clinical research organization (cro)

Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

What is a Contract Research Organization (CRO)?

The health and wellness industry is fiercely competitive, especially within the consumer packaged goods (CPG) sector. In this dynamic environment, where trends rapidly evolve and consumer demands shift, staying ahead of the competition requires constant innovation. This means not only launching new products that resonate with health-conscious consumers but also continuously marketing and enhancing existing products to maintain brand relevance and market share.

To stay ahead of the game and comply with new FTC regulations, an increasing number of consumer brands are turning to third-party Contract Research Organizations (CROs) to conduct clinical research and consumer perception studies for new or existing products. These studies enable CPG brands to develop science-backed product claims, which not only strengthen their marketing strategies but also provide a significant competitive edge in the marketplace.

CROs provide expert services for every stage of research and development, including clinical trial services, consumer perception studies, and data analysis.  Companies can use CROs to focus on their strengths which will help with gr owth.

What is a CRO?

A Contract Research Organization (CRO) helps with clinical trials and research, mostly within the pharma industry. CROs are not only advancing research for new medications and drugs; many are also focused on testing and assessing products for consumer brands. In this overview, we’ll highlight these particular CROs and their role in consumer product research.

By hiring a CRO, companies can leverage their expertise in clinical trial processes, advanced technology, and specialized resources. This ensures that researchers conduct their work efficiently, ethically, and in compliance with all necessary regulations.

CROs help with more than just clinical trials. They assist consumer product companies in skincare, supplements, cosmetics, and pet health industries with research, regulations, data, and marketing. Their services are valuable and make them ideal partners for these companies.

These companies aim to accelerate their development process while maintaining high quality and safety standards.

Key Contract Research Organization Roles and Responsibilities

Understanding the contract research organization's roles and responsibilities is crucial for optimizing your collaboration with a CRO.  ​ A CRO manages all parts of the clinical research process such as study design, data management, analysis, patient recruitment, and regulatory submissions.  Contract research organizations have an important job as they ensure that researchers conduct clinical trials ethically. They also make sure that these trials follow established guidelines.  ​ This involves maintaining stringent quality control measures throughout the study to ensure data integrity and patient safety. CROs often take on the responsibility of navigating complex regulatory environments to ensure that studies meet all local and international regulatory requirements.

Another critical aspect of a contract research organization’s responsibilities is project management. A project manager from the CRO supervises all activities for the clinical trial. They act as a link between the sponsor and the various teams involved in the study. The project manager ensures that communication flows smoothly between all parties. They are responsible for coordinating and managing the project to ensure its success. This role is vital for maintaining clear communication, managing timelines, and ensuring that the project stays within budget. 

By understanding these roles and responsibilities, sponsors can effectively leverage their CRO partnership to achieve successful clinical trial outcomes. ​

Importance of CROs in Clinical Trials and Research

The role of CROs in clinical trials and research cannot be overstated. They offer many important benefits for health and wellness companies, as well as the biotech and medical device industries. 

Cost Efficiency ​

CROs play a pivotal role in helping companies maximize the value of their research and development budgets. By offering cost-effective solutions and access to specialized expertise, CROs enable companies to allocate their resources more efficiently. 

This strategic partnership allows businesses to conduct high-quality clinical trials and research without the burden of investing in extensive infrastructure, technology, or in-house teams. By outsourcing to CROs, companies can reduce operational costs, accelerate timelines, and focus their efforts on core innovations, ultimately leading to a higher return on investment (ROI) and faster time-to-market for new products. ​

Expertise and Technology

CROs have expert teams skilled in different areas of clinical research, such as managing study design, recruiting participants, and analyzing data. This expertise is invaluable in navigating the complexities of clinical trials, regulatory compliance, and data management.

CROs use advanced tools and technologies to enhance the accuracy, speed, and reliability of research data. These tools and technologies help improve the quality of research data.

They also make the research process more efficient. Additionally, they increase the trustworthiness of the data collected. This technological edge is critical in today’s fast-paced research environment.

Citruslabs leverages a technology-first approach to streamline clinical trials for consumer brands, specializing in areas like supplements, skincare, medical devices, and pet health. By integrating advanced technology throughout the trial process, Citruslabs simplifies and accelerates research, making it more accessible and cost-effective. Their goal is to help brands substantiate product claims, enhance credibility, and drive growth by delivering data-driven results that support innovation and market expansion. ​

Accelerated Timelines

CROs have the experience and resources to manage complex trials efficiently, reducing the time required to reach key milestones. This allows companies to bring new products to market faster, giving them a competitive edge. They also help companies improve results by conducting research carefully and efficiently, leading to better product effectiveness, quality, and approval from regulatory authorities.

Who Should Partner with a CRO?

CRO partnerships are particularly beneficial for consumer brands with stricter budgets and faster timelines, here is a breakdown of who would utilize a CRO:

CEOs and Executives: They must ensure that their companies conduct research efficiently and follow all regulatory rules.

Marketing Professionals: Looking to understand consumer perceptions and market trends that will inform product development and marketing strategies.

Researchers and Scientists: Who want to leverage external expertise and resources for research without dealing with complex logistics.

Whether you're launching a new business or looking to enhance your research efforts, partnering with a CRO can be a game-changer. Their expertise and comprehensive support can help you achieve your brand's goals more effectively.

How to Choose the Right CRO

Selecting the right Contract Research Organization is crucial for the success of your research projects. The right partner can provide the expertise, resources, and support necessary to meet your unique needs and goals. Here are some key criteria to consider when evaluating potential CRO partners:

Experience and Reputation

Industry Experience: Look for CROs with a proven track record in your specific industry or research area. Experience in similar projects ensures that the CRO is familiar with the challenges and requirements of your study.

Reputation: A strong reputation and history of successful projects indicate reliability and expertise. Check for client testimonials, case studies, and industry awards to assess the CRO’s reputation.

Service Offerings and Flexibility

Comprehensive Services: Assess the range of services offered by the CRO and ensure they align with your project requirements. A full-service CRO can manage all aspects of your research, from preclinical testing to regulatory submissions.

Flexibility: Choose a CRO that is flexible and willing to adapt to your specific needs. This is particularly important if your project scope is likely to change or if you require customized solutions such as advanced biomarker tracking or blood-work.

Global Reach and Regulatory Knowledge

Global Capabilities: If your research involves multiple regions or countries, choose a CRO with global capabilities. This ensures your research complies with local regulations and enables access to diverse patient populations.  The CRO must understand the regulations in the research areas. This includes understanding what you need to submit and following the rules that different regulatory groups set.

Technology and Innovation

Ensure that the CRO is invested in the latest technologies for data management, analytics, and reporting. This improves data accuracy, reliability, and research efficiency.  Look for CROs that are at the forefront of research advancements. These organizations continuously integrate new methodologies and technologies, providing you with cutting-edge solutions that drive innovation.

Cultural Fit and Communication

Choose a CRO that aligns with your company’s culture and values. A strong cultural fit ensures smooth collaboration and a more productive partnership. Effective communication is critical to the success of any research project. Ensure that the CRO has a clear communication plan in place and that you have regular access to project updates and reports.

Tips for Getting Started with a CRO

Working with a Contract Research Organization (CRO) can greatly benefit your business. However, with that investment, it’s crucial to plan and approach this partnership carefully. Here’s how to get started:

1. Define Your Research Goals

Before partnering with a CRO, it’s important to clearly define your research goals. To run a clinical trial, collect consumer feedback, or handle approvals, you need clear goals. These goals will help you choose the right CRO. They will also ensure a successful partnership.

2. Evaluate Potential CROs

Do thorough research before choosing a CRO partner. Look for companies with experience in your industry and a good track record of producing high-quality results. Consider factors such as the CRO’s service offerings, global reach, and technological capabilities.  Ask potential CROs for their detailed plans on how they will handle your project and inquire about the resources they plan to use. Also, ask about the timelines they suggest for completing the project. This will give you a clear understanding of what to expect from the partnership.

3. Assess Cultural Fit

Alignment with Company Values: Choose a CRO that aligns with your company’s values and culture. A strong cultural fit will ensure smooth collaboration and a productive partnership.  

Communication and Transparency: Effective communication is critical to the success of any research project. Make sure the CRO has a clear communication plan and maintains transparency throughout the research process.

4. Start with a Small-Scale Study

If you’re unsure about committing to a long-term partnership, consider starting with a smaller, and less resource intensive, pilot study. This will allow you to assess the CRO’s capabilities and determine whether they are the right fit for your business.

After the pilot study, evaluate the results and the overall experience of working with the CRO. Use this evaluation to make an informed decision about whether to continue the partnership and invest in longer-term trials or studies.

5. Build a Long-Term Relationship

Working with the same CRO for the long run has benefits. These include consistency, effectiveness, and a deeper understanding of your business needs. Consider establishing an ongoing collaboration that allows you to leverage the CRO’s expertise over multiple projects.  At Citruslabs, we've had the privilege of partnering with numerous health and wellness brands, guiding them through the complexities of clinical research and research-backed product claims.

Visit our Tested Product Page to see how we’ve helped clients run successful clinical trials and consumer perception studies

How CROs Support Health and Wellness Companies

CROs support health and wellness companies by managing clinical trials from beginning to end. They oversee the entire process of clinical trials and provide clinical research and product claims that are backed by science. CROs, such as Citruslabs, play a crucial role in helping consumer brands with their clinical trials. They help accelerate consumer products through efficient trial management, provide comprehensive regulatory support, and enhance research quality with advanced data management and specialized expertise. 

Partnering with a CRO is a strategic move that can accelerate your business's growth while unlocking new opportunities. By streamlining timelines, reducing costs, and improving research outcomes, a CRO can help you bring impactful products to market more efficiently. This collaboration not only drives innovation but also enhances your team's morale, empowering them to achieve more.

Why Choose Citruslabs?

At Citruslabs, we believe that every brand is unique, and research should be designed to reflect that. We are here to support you with your clinical research needs - from start to finish. Rather than relying on a standard approach, we personalize each study to match your particular goals. This means that our pricing adjusts based on the varied elements of your research needs. Our aim is to provide a creative and budget-conscious solution that is closely aligned with your specific research objectives.

Contact us to learn how we can help you conduct thorough clinical research for your products. 

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What Is a CRO?

Pharmaceutical, biotechnology and medical device companies initiate, manage and fund clinical trials and are ultimately responsible for the clinical trial process. They are referred to as sponsors. Clinical trial sponsors also include government agencies, such as the National Institutes of Health (NIH) in the United States, and non-profit organizations.

The research and development process for a single drug can require the participation of thousands of people. It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion. It is a long, complex and expensive process, and many sponsors are not equipped, resourced or prepared to perform all trial-related duties and functions themselves.

For this reason, sponsors may choose to outsource all or part of the trial-related tasks to a company called a contract research organization (CRO) – sometimes called a clinical research organization – to manage the clinical trial on their behalf, without sponsors having to maintain a staff for these services. CROs have the capacity to conduct the day-to-day research activities that are either not possible or too expensive for a sponsor to achieve in-house. CROs are experts in the space and active partners in clinical research.

• A CRO's Role in Pharmaceutical Development
• Functions of a CRO
• Clinical Research and Trial Management
• Global and Specialized CRO Services

“It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion .”

CROs in the United States

the size that the global CRO market size is expected to reach, in dollars, in 2023

What is a CRO’s role in pharmaceutical development?

CROs play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide .

The services that a CRO may offer can cover the full timeline of the study:

• The development and revision of protocols for trials
• The adaptation of the necessary documentation to the applicable rules
• Obtaining the necessary approvals from clinical research ethics committees and regulatory authorities
• The design and preparation of case report forms
• The determination of the sample
• The selection of the best researchers and research centers
• The final negotiation of the contracts among all parties (the CRO, vendors and sites).
• Once regulatory approval is obtained and the trial begins with site selection and patient recruitment, the CRO can provide monitoring , which consists of controlling compliance with the protocol and the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in case of any adverse event (AE).
• The last steps to ensure the success of any clinical study are the statistical analysis and management of the trial data , the generation of reports (including the clinical study report for submission to regulatory authorities for drug approval) and the control and storage of the documentation.

CRO structure

A Contract Research Organization (CRO) acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.

(Leon Research, https://leonresearch.com/what-is-a-cro-and-how-can-it-help-you-in-your-clinical-trial/ )

Functions of a Contract Research Organization

Typically, a CRO provides scientific, clinical and business continuity for clinical trial sponsors. The CRO can be involved in a range of services from pre-clinical research (which takes place before human trials) to post-marketing surveillance (which takes place after a product has been approved for use).

Other administrative activities may include strategic consulting and protocol development, laboratory and analytical services, project management, trial logistics, medicine and disease coding, statistical analysis and reporting, validation programming, safety and efficacy summaries and the final study report.

Clinical research and trial management

A sponsor hires a CRO to plan, coordinate, execute and manage the life cycle of the clinical trial safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians and research coordinators.

Clinical trials conducted by CROs are completed on average 30 days faster than those conducted by sponsor companies. 1

Every day counts for both patients (who may be anxiously waiting on therapies that could improve or even save their lives) and sponsors (because time spent in the development process counts against the patent protection period after the drug goes to market, affecting sales revenue).

35 years of experience

With more than 35 years of experience, the PPD™ clinical research business of Thermo Fisher Scientific offers an established drug development platform, patient enrollment expertise and robust laboratory services . Our broad range of clinical development, analytical and patient and advisory services – including full service to functional service provider services , digital and decentralized trials, and laboratories – enables customers to drive innovation and increase drug development productivity. We are recognized for accelerating promising medicines from early development through regulatory approval and market access. Our flexible, custom-tailored solutions serve pharmaceutical, biotech, medical device, academic, government and public health organizations in clinical research and development .

Global and specialized CRO services

Most large CROs are full-service, providing complete clinical trial management support, but there are some companies specializing in a specific type of study (e.g., research with medical devices or observational studies) and also CROs specializing in a specific therapeutic area, such as oncology or ophthalmology.

Global CROs, large companies with operations all over the world, provide greater, integrated geographical coverage, with more service offerings and capabilities, while local companies may sometimes have more in-depth knowledge of a particular country’s nuances and demographics as they relate to clinical development.

Global network

The global network consisting of clinical sites within the PPD™ clinical research business of Thermo Fisher Scientific and non-owned partner sites offers access to a diverse pool of healthy volunteers and specialty populations around the world. Our experienced staff provides external oversight of a trial, working directly with the institutions where clinical studies are conducted – hospitals and clinics, called investigational sites. We provide training to the principal investigator and the site staff, and ensure that the safety, rights and well-being of patients are protected; that the conduct of the trial is in compliance with regulatory requirements; and that reported trial data are accurate and complete.

What is the difference between a CRO and a sponsor?

Although the sponsoring company may transfer the trial functions to a CRO, the sponsor owns the investigational product and needs to ensure results are factual and scientifically backed. 

According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , a CRO is: “A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” 

The sponsor maintains a central role throughout the clinical trial process. Although regulatory tasks differ globally, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly).

The ICH Guideline for GCP specifies the responsibilities a CRO can take over from a sponsor : 

• 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
• 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

What are the advantages of outsourcing to a CRO?

A CRO can offer substantial cost savings for a sponsor by reducing the time it takes to conduct a trial compared to a sponsor doing so in-house. This also eliminates the need for staff, infrastructure and lab and office space for the sponsor to run the trials themselves. Finally, a full-service CRO can provide access to a global network of clinical research sites, meaning it can quickly identify suitable sites for clinical trials in multiple countries. Geographical reach or therapeutic focus can be important in patient recruitment, especially in specific populations, such as underserved and diverse , or for rare diseases that affect a small subset of people.

Working with a CRO gives sponsors access to the most advanced technology and systems for data management, product development, research analysis and other clinical research services. CROs are quick to adopt the latest technologies, enabling them to provide strategic insights and advice, and to offer novel and distinctive ways to use advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Given that CROs work with many different sponsors, they often have a breadth of experience beyond even a single large pharmaceutical company.

CROs adhere to clinical compliance on a daily basis, which requires intricate in-house knowledge of regulatory requirements and audits such as GCP (Good Clinical Practice) or GLP (Good Laboratory Practice) audits.

Sponsors conducting clinical research in a niche area such as rare disease may choose to work with a specialty CRO or a global CRO with offering such services.

We have an extensive global network of investigators, clinicians and partners with a wide range of products, technologies and services that can be leveraged for clinical trial conduct. Our goal is to deliver considerable time and cost savings in drug development, critical to accelerating the delivery of life-changing therapies. Our experts consider the end before the beginning by envisioning and planning for commercialization and market acceptance well before the first patient is enrolled in a clinical trial. And before trials are underway, we design for post-approval, real-world patient observation that provides support for payer authorizations and may lead to new  ideas and products .

How does a sponsor select a CRO?

When selecting a CRO, here are some questions to consider:

• Can the CRO offer the services that the sponsor needs?
• Does the CRO have related experience and a good track record (i.e., similar projects and references or testimonials from satisfied clients)?
• Is the CRO financially stable?
• Does the CRO have a good system for employee training and a low staff turnover rate?
• Does the CRO have the key staff members required and can it set up a team to deliver qualified results?
• Does the CRO have the required infrastructure?
• Does the CRO have a robust quality assurance system?
• Is the CRO’s team responsive and willing to work with you and communicate throughout the project?
• Does the CRO have specialty services, laboratories, digital and decentralized solutions, a clinical supplies network and other capabilities important to your drug development program?
• Will the CRO help you recruit and manage safety boards or committees?
• Will the CRO conduct audits to help you prepare to pass FDA inspections?
• Can the CRO provide general site support and project management help in addition to clinical monitoring?
• Does the CRO function as a vendor or a true partner ?

Drive your drug development program forward

Partner with a leading, global provider of CRO solutions that leverages a proven track record and deep expertise to keep the patient at the forefront of your trial.

The PPD clinical research business of Thermo Fisher Scientific accelerates your success with a dynamic, forward-thinking approach, a comprehensive suite of capabilities and true partnership with our customers.

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What is a Clinical Research Organization?

The four phases of clinical trials.

• Establishes the effect of a new drug in humans
• Usually conducted on small (12-50) populations of healthy volunteers and/or patients
• Determines a drug's toxicity, absorption, distribution, metabolism and excretion
• Tests a drug for safety and efficacy in a relatively small (200-500) population of patients
• Patients are afflicted with the disease or condition for which the drug is being developed
• Tests the drug in relatively large populations of patients (500-5,000 or more)
• Usually compares the new drug to placebo or to the standard therapy currently being used for the disease of interest
• Results usually provide package insert info (Prescribing Information for doctors, and Patient Information materials)
• Conducted after a drug has been approved by a Regulatory Authority
• Compares the drug to competitor drugs, to explore additional patient populations or disease indications, or to further assess the safety of the drug

Key Functions of CROs

CROs serve as an important component of the drug development ecosystem, offering a wide range of services that encompass every phase of the clinical trial process. Some of the key functions of CROs include:

Protocol design and development : CROs assist sponsors in creating robust and scientifically sound study protocols that define the scope, objectives, and methodologies of the clinical trial.

Patient recruitment and retention : CROs employ various strategies to identify and enroll eligible patients for clinical trials, ensuring that participant targets are met. They also focus on patient retention through engagement and support.

Regulatory and ethics compliance : CROs navigate complex regulatory requirements and ensure adherence to ethical considerations, protecting the rights and well-being of study participants.

Clinical trial operation : CROs manage the day-to-day operations of clinical trials, including site selection, monitoring, data collection, and adverse event reporting, among other activities.

Data management and biostatistics : CROs employ advanced technologies and robust data management systems to collect, scrutinize, and analyze trial data, generating high-quality evidence to support regulatory submissions.

Quality assurance and control : CROs implement comprehensive quality assurance measures to ensure that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, industry standards, and regulatory requirements.

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2024: An Endeavor into the Enigma - Uncovering the Substance of CROs

Reflecting on the complexities inherent in the acronyms CRO (Clinical Research Organization) and CRA (Clinical Research Associate) indeed reveals a multifaceted landscape within the realm of clinical research. For those deeply entrenched in the nuances of clinical inquiry, understanding the operational mechanisms of CROs emerges as a pivotal journey delving into the uncharted territories of healthcare advancement. Whether venturing into the realms of clinical research for the first time or seeking a renewed perspective, delving into the semantic intricacies of CROs and unlocking their transformative potential in healthcare becomes an essential exploration, propelling organizations towards unparalleled developmental heights.

The Essence of a CRO:

Clinical Research Organizations, abbreviated as CROs, epitomize entities entrusted with the management of clinical trials on behalf of pharmaceutical and biotechnological giants. Their mandates encompass the selection of patients, procurement of informed consent, aggregation of data, and the persistent oversight of safety protocols. CROs are broadly categorized into two overarching classifications: full-service CROs, offering a spectrum of services essential for clinical trials, and specialized CROs, focusing their expertise on specific areas such as patient enrollment or data management.

The Era of CRO Dominance:

A seismic shift characterizes the ascendancy of CROs in recent chronicles. The tally of clinical trials orchestrated by CROs surged from 9,000 in 2006 to a staggering 26,000 in 2016. This remarkable ascent fundamentally attributes itself to the accessible expertise and efficiency that CROs demonstrate, all at a cost-effective rate compared to traditional avenues of research. Moreover, the integration of CROs into the operational framework enables pharmaceutical and biotechnological entities to sharpen their core competencies while concurrently mitigating the looming specter of clinical setbacks.

Navigating the Intersection of Costs and Benefits:

However, amidst the commendable merits inherent in CRO engagement, a caveat looms ominously. Skepticism burgeons regarding the equivalence of expertise, with concerns revolving around the potential discrepancy in data quality vis-à-vis conventional research entities. A lingering unease surfaces, questioning the parity of commitment to patient safety between CROs and their traditional counterparts. Navigating through the intricate labyrinth of CRO utilization necessitates a judicious assessment, a meticulous weighing of the benefits against the potential pitfalls in the steadfast pursuit of advancing the uncharted territories of healthcare improvement.

Clinical investigate organizations, recognized as contract inquire about substances, expand outsourced administrations to the pharmaceutical and biotechnology divisions. These organizations organize clinical trials for inventive pharmaceuticals and restorative approaches. The engagement of CROs can be started either by the pharmaceutical companies themselves or by the scholastic teach initiating the trials. The CRO industry has been encountering exponential development in later a long time. In 2024, the worldwide CRO administrations showcase gathered an evaluated $25.1 billion in 2024, with projections showing a compound yearly development rate of 7.5% over the resulting five a long time. Clinical inquire about administrations constituted the most considerable share of this advertise, measuring to $19.8 billion in 2024. Multiple variables contribute to the thriving of the CRO industry. At first, there has been a essential surge in the around the world conduct of clinical trials. Hence, a move from minute, casual trials to sweeping, formal trials overseen by commercial CROs has been watched. Thirdly, there is a recognizable uptick in the outsourcing slant among pharmaceutical and biotechnology enterprises. The essential on-screen characters in the CRO division include major multinational substances such as QuintilesIMS, Covance, and Parexel. At the same time, an developing unexpected of littler CROs specializes in specific restorative spaces or particular trial categories, extending the industry's scope and diversity. So, what absolutely constitutes the modus operandi of a CRO in 2024? In pith, a CRO outfits a comprehensive cluster of administrations including consider conceptualization, ponder execution, watchfulness, information administration, and expository interests. Furthermore, they habitually apportion administrative backing administrations like creating entries and conducting administrative audits. The vital advantage of locks in a CRO dwells in its capacity to speed up the medicate advancement direction. By subcontracting select or whole clinical trial endeavors, pharmaceutical enterprises in 2024 stand to abridge consumptions and rescue time. CROs, blessed with capability in executing clinical trials, adeptly encourage effective and compelling trial executions, subsequently progressing the field of pharmaceutical investigate.

What are the benefits of Clinical Research Organizations?

There are many benefits to working with a Clinical Research Organization (CRO). Perhaps the most important benefit is that CROs can help you to move your clinical research program forward faster and more efficiently. They have the experience and expertise to help you manage all aspects of your study, from start to finish. This can save you a lot of time and money, as CROs know how to navigate the complex world of clinical research.

Another major benefit of using a CRO is that they can help you to reduce risk. By using their experience and knowledge, CROs can help you to select the right study participants, design the study correctly, and implement best practices throughout the study. This can help to minimize any potential risks involved in conducting your study.

Finally, CROs can also help sponsors save money. They have established relationships with vendors and suppliers, so they can often get better deals on study materials and services than you would be able to negotiate on your own. This can result in significant cost savings for your clinical research program.

What are the challenges of Clinical Research Organizations?

The burgeoning domain of Clinical Investigate Organizations (CROs) experiences a heap of challenges in the year 2024. The quick development of this industry applies colossal weight on CROs to speed up and streamline considers, frequently coming about in hurried and substandard work. Concurrently, the basic to reduce costs holds on, coupled with the heightening complexities of administrative orders. Besides, hooking with furious competition from financially beneficial countries includes an extra layer of complexity, given their capacity to give cost-effective services.

These multifaceted challenges have accelerated various misgivings with respect to the quality and security guidelines inside the CRO space. A chronicled occasion in 2013 seen the FDA issuing a cautionary note to a CRO locked in in sedate company considers. The reprobation highlighted different deficiencies in the CRO's endeavors, including insufficient consider plan, subpar information administration, and a shortage of satisfactory observing protocols.

In a more later occurrence, circa 2013, another FDA caution resulted, provoked by a quiet casualty amid a clinical trial conducted by a CRO. The administrative body perceived insufficiencies in the CRO's oversight, showing in an insulant checked ponder and the disappointment to report grave antagonistic events.

These outlines only scratch the surface of the horde security worries that have tormented the CRO scene all through the a long time. The need of exacting quality control measures and inadequately observation can possibly result in extreme wounds or indeed fatalities for people taking an interest in clinical trials. Tending to these security concerns orders a concerted exertion. The FDA has spread direction archives and administrative goals pointed at improving the caliber of CRO endeavors. At the same time, pharmaceutical substances must work out increased acumen in selecting capable CROs whereas giving persevering oversight. Planned patients are empowered to attempt exhaustive investigate some time recently enlisting in clinical trials and ought to posture related inquiries with respect to the trial's procedural conduct.

Innovative Approaches to Better Clinical Research Organizations in the Year 2024

In the scene of clinical investigate organizations (CROs) as of 2024, there is a essential require for upgrade to guarantee the viability of clinical trials. The necessarily part of CROs in the arranging, execution, and documentation of clinical inquire about thinks about requires a sharp center on advancement strategies.

To move the advancement of CROs in 2024, one vital road includes the outsourcing of clinical inquire about preparing. By entrusting this pivotal viewpoint to outside substances, CROs can ensure comprehensive preparing in best hones, cultivating the conveyance of trials of the most elevated quality. This approach too serves to keep CROs side by side of cutting-edge advances and winning patterns inside the field, contributing to their ceaseless refinement.

Another essential road for the upgrade of CROs lies in the enlargement of straightforwardness. This means the basic of making operational subtle elements of CROs freely open. Such straightforwardness envelops illustrating the strategies utilized by CROs, uncovering the results of their considers, and uncovering the charge structures they execute. By grasping straightforwardness, the moral operation of CROs is shielded, guaranteeing impartial treatment of patients.

In the broader setting, the change of CROs in 2024 is a multifaceted endeavor. Outsourcing clinical inquire about preparing and cultivating straightforwardness rise as linchpin procedures to accomplish this overarching objective.

While CROs irrefutably constitute a significant aspect of the clinical inquire about prepare, their adequacy pivots on tending to characteristic challenges. Moved forward communication and straightforwardness with supports, destinations, and patients are basic for CRO viability. Emphasizing quality over amount is vital to maintain a sterling notoriety inside the industry. If diving more profound into the complexities of clinical investigate organizations interests you, consider selecting in our clinical inquire about certification course for an smart investigation of their working.

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The meaning of triage: a guide for the clinical research professional.

A Comprehensive Guide to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) play a crucial role in the pharmaceutical, biotechnology, and medical device industries. They provide support to companies in the form of research services outsourced on a contract basis. In this comprehensive guide, we will explore what CROs are, who their clients are, the stages of the research process they are typically involved in, and delve into the exciting career opportunities within the field of clinical research.

Table of Contents

Introduction to Clinical Research Organizations (CROs)  The Role of CROs in the Research Process  Services Offered by CROs  Clients and Partners of CROs  Careers in Clinical Research  Clinical Research Associate (CRA) Roles and Responsibilities  Educational and Professional Requirements for Clinical Research  Careers Advancement Opportunities in Clinical Research  Tips for Success in Clinical Research  Careers Resources and Professional Organizations  Conclusion

Introduction to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. They offer a wide range of services , including biopharmaceutical development, clinical development, clinical trials management, and pharmacovigilance. CROs aim to simplify the entry into drug markets and streamline the drug development process by providing specialized expertise and resources.

The Role of CROs in the Research Process

CROs play a crucial role in the research process, from the early stages of drug discovery and development to the final stages of clinical trials and commercialization. They work closely with their clients to design and execute clinical trials, ensuring adherence to regulatory requirements and ethical standards. CROs also provide support in data management, statistical analysis, and the preparation of regulatory submissions.

Services Offered by CROs

CROs offer a wide range of services to their clients, including but not limited to: 

Biopharmaceutical development : CROs assist in the development of new drugs, from preclinical studies to early-phase clinical trials. Clinical development: CROs design and manage clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Clinical trials management: CROs oversee all aspects of clinical trials, including site selection, patient recruitment, data collection, and safety monitoring. 

Pharmacovigilance : CROs monitor the safety of drugs and medical devices during clinical trials and after they are on the market. 

Real-world evidence and outcomes research : CROs collect and analyze data from real-world sources, such as electronic health records, to generate evidence on the safety and effectiveness of drugs and medical devices. CROs conduct studies to evaluate the effectiveness and safety of drugs and medical devices in real-world settings. 

Clients and Partners of CROs

CROs work with a diverse range of clients, including pharmaceutical  companies,  biotechnology firms, medical device manufacturers, research institutions, and government organizations . They collaborate closely with their clients to ensure that research studies are conducted efficiently, safely, and in compliance with regulatory requirements. CROs also partner with academic institutions and foundations to support their research initiatives.

Careers in Clinical Research

Clinical research offers exciting career opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. 

Careers in clinical research span a wide range of roles, including Clinical Research Associate (CRA), Clinical Project Manager, Data Manager, Biostatistician, and Medical Writer, among others. These roles require a combination of scientific knowledge, attention to detail, critical thinking, and strong communication skills.

Clinical Research Associate (CRA) Roles and Responsibilities

Clinical Research Associates (CRAs) play a crucial role in the execution and monitoring of clinical trials. Their responsibilities include site selection and initiation, monitoring study progress, ensuring compliance with protocols and regulatory requirements, and maintaining accurate and complete documentation. CRAs work closely with investigators, study coordinators, and other stakeholders to ensure that trials are conducted safely and efficiently.

Educational and Professional Requirements for Clinical Research Careers

Careers in clinical research typically require a strong educational background in life sciences or a related field. Many positions, such as CRAs, require a bachelor's or master's degree in a scientific discipline. Professional certifications, such as the Certified Clinical Research Associate (CCRA) certification, can enhance career prospects and demonstrate expertise in the field.

Advancement Opportunities in Clinical Research

Clinical research offers ample opportunities for career advancement and professional growth. Experienced professionals can progress to more senior roles, such as Clinical Project Manager or Clinical Operations Director, where they oversee the planning and execution of multiple clinical trials. Continuing education, networking, and staying updated with industry trends are essential for career advancement in clinical research.

Tips for success in seeking a Career in Clinical Research

To succeed in clinical research careers, professionals should continuously develop their scientific knowledge, stay updated with regulatory requirements, and enhance their communication and project management skills. Networking, building relationships with key stakeholders, and seeking mentorship can also contribute to career advancement in the field.

Resources and Professional Organizations for Clinical Research Professionals

Several resources and professional organizations cater to the needs of clinical research professionals. These include industry publications, online forums, conferences, and professional associations. Organizations such as the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) provide educational resources, networking opportunities, and professional certifications for clinical research professionals.

Clinical Research Organizations (CROs) play a vital role in the pharmaceutical, biotechnology, and medical device industries by providing research services on a contract basis. They offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Careers in clinical research offer exciting opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. By partnering with CROs and pursuing careers in clinical research, professionals can contribute to the advancement of medical science and the development of innovative therapies.

If you're interested in exploring careers opportunities in clinical research, view our current vacancies at ICON today.

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When austin was 3 years old, his parents realized something was wrong..

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With 10+ years of experience in rare diseases and cell and gene therapy trials, Rachel leads our global, cross-functional Center of Excellence for Rare Diseases. She supports strategies to deliver your projects effectively, ensuring the patient perspective is included every step of the way.

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What Is a CRO And How Can They Help You?

by Siron Clinical | Jul 28, 2021

A clinical trial involves complex overlapping processes, many of which require specialized expertise and experience. So how can you run a clinical trial successfully if you don’t have the expertise in-house? That’s where a CRO comes in.

What Is a CRO?

A contract research organization, or CRO, supports the biotech, medical devices and pharma industries by providing clinical research services. Working with a CRO can be a cost-effective way of ensuring the expertise and experience needed, especially for companies carrying out research in niche markets.

The services a CRO provides vary depending on what the client needs. They can cover the span of the clinical research process, from preclinical research to pharmacovigilance (clinical trial phases I to IV) and other services, such as commercialization and the development of assays and biopharmaceuticals.

Since CROs range in size, from small organizations to large multinationals. They often specialize in certain areas – especially the smaller organizations. For example, they may provide services in specific areas, or focus on a number of therapeutic areas. By specializing like this, CROs can ensure they have the expertise needed in the areas in which they work.

The CRO’s Role In The Clinical Trial Process

One specific area in which CROs support clients is setting up, managing and closing clinical trials. CROs that specialize in clinical trials – including Siron Clinical – often work on every part of the process, from setup, which requires expertise in regulations, to FDA or EMA approval and ongoing monitoring.

According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , a CRO is: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”

The sponsor has a central role throughout the clinical trial process. Although regulatory tasks differ in the EU and the US, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly). The sponsor is responsible for managing and financing the trial.

The ICH Guideline for Good Clinical Practice (GCP) specifies the responsibilities a CRO can take over from a sponsor :

• 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
• 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

How Siron Clinical Can Support You

As a CRO specialized in clinical trials, Siron Clinical can support your trial with services covering the entire process.

• Project Management , including developing and tracking study timelines, ensuring all activities are within scope and budget, coordinating and executing Clinical Trial activities and acting as the central point of contact for the client.
• Clinical Monitoring , including protocol, regulatory and ICH GCP compliance verification, site personnel training and pharmacovigilance: assisting and ensuring appropriate reporting of CIOMS, DSURs, annual IDB updates.
• Quality Assurance / Control , including clinical study document review, accompanied site visits and inspection preparation site visits.
• Regulatory Submissions , including regulatory advice, preparation and submission of dossiers, and acting as EU Legal or Data Controller representative.

You can benefit from these services across a range of therapeutic areas in which we have experience . Over the last 20 years, we have worked on 120 complex clinical trials, including orphan indications, pediatric, cardiovascular, oncology, hepatology and dermatology studies.

To find out how Siron Clinical can support your clinical trial, contact our team .

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CROs are recognized as strategic partners for sponsors seeking to manage and conduct clinical trials efficiently. They assist in study design, which involves determining the research objectives, defining the study population, and selecting appropriate endpoints and outcome measures. CROs bring their expertise in research methodology and regulatory requirements to help sponsors design studies that are scientifically rigorous and aligned with regulatory expectations.

Does a CRO assist with trial site selection?

Site selection is another crucial aspect of CRO operations. CROs evaluate potential trial sites based on factors such as patient population, infrastructure, and investigator experience. By conducting thorough assessments, CROs ensure that the selected sites have the necessary capabilities to execute the trial effectively and recruit eligible patients. This process significantly contributes to the successful implementation of clinical trials.

Is patient recruitment part of the CRO remit?

Patient recruitment is often a significant challenge in clinical research. Working with sites, CROs employ various strategies to optimize patient recruitment , such as implementing targeted advertising campaigns, utilizing patient databases, and collaborating with healthcare providers and patient advocacy groups. By employing these approaches, CROs help sponsors enroll the desired number of participants within the designated time frame, ensuring that the trial progresses as planned.

What is covered in the data management process?

Data management is a critical component of clinical trials, and CROs play a vital role in ensuring the integrity and accuracy of data collected. They develop comprehensive data management plans, which include processes for data collection, cleaning, validation, and storage. CROs also leverage advanced technologies and systems to streamline data collection and facilitate real-time access to study data, enabling timely analysis and decision-making.

Does the CRO manage site monitoring?

Monitoring is an essential aspect of clinical trials, and CROs conduct regular visits to trial sites to assess protocol adherence, data accuracy, and patient safety. These visits, known as monitoring visits, involve reviewing source documents, verifying data against case report forms, and identifying and addressing any deviations or issues. Through monitoring, CROs ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.

Is regulatory compliance a key feature of CRO services?

Regulatory compliance is a fundamental responsibility of CROs, who navigate the complex regulatory landscape governing clinical research. They ensure that trials adhere to local regulations, international guidelines, and ethical standards. CROs maintain regular communication with regulatory bodies, facilitating the submission of necessary documentation and approvals. By upholding regulatory compliance, CROs ensure the reliability and validity of trial results.

Does the CRO service include overall project management?

Project management is a crucial function provided by CROs, encompassing the coordination and oversight of all trial activities. CROs develop comprehensive project plans, establish timelines, allocate resources, and monitor progress to ensure the smooth execution of clinical trials. Effective project management ensures that trials are conducted efficiently, within budget, and according to the predefined timelines.

Does the CRO manage data analysis?

Data analysis is a critical step in clinical research, and CROs possess expertise in statistical analysis and interpretation. They employ advanced statistical methods to analyze trial data, generate insights, and draw meaningful conclusions. Through data analysis, CROs contribute to the evaluation of treatment efficacy, safety profiles, and patient outcomes, ultimately supporting evidence-based decision-making.

What is covered in pharmacovigilance?

Pharmacovigilance is an integral part of CRO operations, focusing on the detection, assessment, understanding, and prevention of adverse events associated with investigational drugs. CROs develop robust pharmacovigilance systems and processes to ensure the ongoing safety monitoring of trial participants. By promptly identifying and reporting adverse events, CROs contribute to the overall safety and well-being of study subjects.

Does the CRO manage regulatory submissions?

Regulatory affairs form a crucial aspect of CRO services, involving the compilation and submission of regulatory documents to obtain necessary approvals from regulatory authorities. CROs assist sponsors with global regulatory writing and consulting , preparing regulatory submissions, including investigational new drug applications, ethics committee approvals, and clinical study reports. Their knowledge of regulatory requirements and expertise in document preparation streamline the approval process, enabling timely initiation and completion of clinical trials.

The global landscape of CROs is marked by their presence in various regions across the globe. CROs have the expertise to navigate local regulations, cultural nuances, and language barriers. This global reach enables them to conduct multinational trials, ensuring the inclusion of diverse patient populations and enhancing the generalizability of trial results.

The CRO industry is witnessing emerging trends that are shaping the future of clinical research. The integration of digital technologies, such as electronic data capture systems, remote monitoring solutions, and wearable devices, has revolutionized data collection and patient engagement. These technologies enhance the efficiency and accuracy of data capture, minimize errors, and improve the overall patient experience.

What is RWE?

Real-world evidence (RWE) utilization is gaining prominence in the CRO industry. CROs leverage RWE, which includes data from real-world settings, such as electronic health records and claims databases, to complement traditional trial data. By incorporating RWE, CROs enhance the understanding of treatment effectiveness, safety profiles, and patient outcomes in real-world populations, providing a comprehensive view of therapeutic interventions.

What is adaptive trial design?

Adaptive trial designs are becoming increasingly prevalent in clinical research, allowing trials to be modified and optimized in real-time based on accumulating data. CROs embrace adaptive trial designs, enabling sponsors to make data-driven decisions, refine study protocols, and enhance trial efficiency. These designs maximize the use of resources, reduce timelines, and improve the likelihood of trial success.

CROs are instrumental in advancing clinical research and the development of new therapies. Through their multifaceted services, including study design, site selection, patient recruitment , data management, monitoring, and regulatory affairs, CROs ensure the highest standards of quality, safety, and ethical conduct in clinical trials. They play a pivotal role in accelerating the drug development process, improving efficiency, and reducing costs for sponsors. As the global landscape of clinical research continues to evolve, CROs navigate local regulations, embrace emerging trends, and leverage advanced technologies to drive innovation and contribute to the translation of scientific discoveries into tangible benefits for patients worldwide.

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What is a contract research organization plus, top 5 cros to check out in 2022.

What is a CRO?

A contract research organization – CRO – is a company that provides outsourced services related to drug development and clinical research. Pharma and biotech firms and other sponsors may rely on a CRO for support in one or more aspects of developing and bringing new drugs and medical devices to market.

Keep reading as we explore the role of CROs in drug development, what services they offer, and why many sponsors work with one. We’ve also included a list of the top 5 CROs, and questions to ask before signing a contract with a CRO.

What Do CROs Do?

The main role of CROs is to carry out activities that the sponsoring pharmaceutical company cannot or chooses not to do in-house.

Pharmaceutical companies often count on both internal and external resources, and sometimes they need assistance with tasks that fall outside of their core capabilities. Most modern CROs provide services spanning the drug development pipeline, from running entire clinical trials to individual services such as data management, patient recruitment, protocol development, drug manufacturing, and the list goes on. CROs themselves might partner with other companies to provide robust services across the full spectrum of clinical trial activities. For example, CROs might partner with Power as a part of a multi-layered recruitment strategy for a trial.

The goal of a CRO is to provide streamlined services to pharmaceutical companies in order to help them get their new drugs developed, tested, and approved. It’s often more resource efficient and quicker to outsource certain aspects of clinical development, allowing sponsors to focus on their core operations.

For example, let’s say a biotech company has developed a new drug that looks promising in preclinical laboratory tests, but they’ve never conducted a clinical trial. It would generally be much more straightforward and efficient to partner with a CRO to conduct clinical trials than to dive into the complex regulatory landscape and risk inefficiencies or failures in the clinical testing of their promising new drug. Although the biotech firm would still be the sponsor of the trial, retaining responsibility for regulatory compliance, the CRO would be responsible for recruiting patients, administering the study drug, monitoring patients and overseeing the trial, and reporting the results back to the company. Each of these aspects is, in and of itself, a whole world that requires specialized expertise. It makes much more sense to outsource these aspects to dedicated professionals.

See the image below for some example services offered by CROs:

Are contract research organizations the same as clinical research organizations?

Contract research organizations (CROs) may get involved in all aspects of the clinical development process, from initial drug discovery through to pre-clinical and clinical trials and post-marketing surveillance studies. A CROs might help design a study, recruit patients for the study, perform laboratory tests, monitor patients during the study, analyze study data, prepare study reports for the sponsor, and present reports or summaries to regulatory bodies.

Clinical research organization is a less-common term which might be used to refer to a specific type of CRO that specializes in conducting clinical trials for pharmaceutical companies and other sponsor organizations. Thus, where a CRO might offer comprehensive service across the clinical development spectrum, a clinical research organization would be focused primarily on conducting phase I through phase IV studies for new drugs and medical devices.

Why do sponsors work with CROs?

CROs play an important role in pharmaceutical and biotechnology product development. Here are just some of the reasons why sponsors may decide to work with CROs:

1. Specialized operations and cost control

Building and managing clinical trial operations completely in-house is complicated, expensive, and requires specialization in a multitude of areas. The rise of CROs meant that pharmaceutical companies no longer needed to own all of their own scientific and clinical research facilities. Full-service CROs offer sponsors a complete set of solutions, allowing them to delegate as much or as little of the overall clinical development operation as they desire so as to optimize resource use and development timelines.

2. Expanded access to technology

CROs offer various technological solutions to support sponsors in designing, conducting, and managing clinical trials. Many of these tools are specific to clinical trials, and would not be commonplace in a lab-focused pharmaceutical company, for example. Sponsors can choose to leverage these technologies or product suites depending on the needs of each unique study. Some examples of eClinical technologies that sponsors may use include: planning tools (protocol design, patient enrollment, etc.); site management tools (activation, payments, etc.); modern patient recruitment tools (e.g., Power ); clinical trial management systems ( CTMS ); clinical data management systems (CDMS); analytics platforms.

3. Ability to handle large amounts of data

There are a lot of moving pieces involved in successfully running a clinical trial. CROs with experience in clinical trials will have efficient data handling procedures in place, making them a reliable partner for this complex aspect of modern trials which often draw from various data sources such as wearable devices, EHRs, eCOA / ePRO interfaces, etc.

4. Streamlined regulatory affairs (FDA regulatory compliance)

CROs typically have experience working with regulatory agencies such as the Food and Drug Administration (FDA). The FDA regulates the entirety of clinical trials, ensuring that ethical research guidelines and patient privacy safety standards are upheld. Sponsors must adhere to a multitude of FDA and HHS guidelines when conducting any clinical trial. Regulatory affairs is a complex landscape requiring familiarity with various parallel and overlapping regulations, as we discuss in our explainer on regulatory compliance in clinical trials . An experienced CRO will be able to help pharmaceutical companies get their products to market faster by facilitating regulatory submissions and navigating the intricacies of guidelines laid out in Title 21 and 45 CFR, GCP, HIPAA, etc. Partnering with a CRO offers an attractive alternative to hiring and training internal experts specializing in regulatory affairs, particularly for sponsors who aren’t conducting trials frequently.

5. Multi-disciplinary expertise leads to quicker and more effective trials

CROs often consist of a team of professionals with diverse backgrounds and specializations, which means that they can offer the appropriate expertise needed to effectively manage various aspects of clinical trial operations.

What to ask when choosing a CRO partner for clinical research

With the massive offer of CROs currently available, it’s important to realize the weight of the decision when selecting partners for clinical research. As the sponsor, regulatory compliance falls entirely under your responsibility, so choosing a trustworthy partner with a proven record of compliance can help you be sure your trial is in the right hands. Partnering with an incompetent or inexperienced CRO may have the opposite effect of streamlining trial timelines and resource usage, causing delays and risking valuable resources or even patient health.

The following 3 points act as a guideline for choosing a potential CRO before signing a provider agreement with them for a clinical trial, regardless of the extent of their involvement.

1. Obtain trustworthy information. It's important to gather as much information as possible about a potential research partner, as there is significant weight placed on such agreements. The website of the CRO itself will not tell the whole story; it is a good idea to look for real reviews and feedback from other companies who have worked with the CRO.

Make sure that the CRO you are considering has an established track record of success with past and current clients. Check that the CRO has an active online presence and transparent contact information, along with active client support.

The CRO should also have a good reputation among its employees; complaints by employees might be a red flag, particularly if they’re related to protocol deviations, non-compliance, mismanaged client disputes, internal uncleanliness or disorganization, or other issues that could impact patient safety and regulatory compliance.

2. Check that the CRO is up-to-date with regulatory standards and accreditations. The regulatory landscape is updated frequently, so it’s important to verify that the CRO in question has been active recently and has up-to-date authorization and accreditation for the specific operations you are considering contracting them for. If you can’t find this information on the website, contact them and have an open discussion to get clear answers.

3. Verify that the CRO has real expertise in the specific task you wish to outsource. This may seem obvious, but just because a given CRO is world-renowned in conducting clinical trials does not mean they will be experts in analyzing your specific data, particularly if you’re working in rare diseases or other niche areas. Direct experience in a similar therapeutic field and trial type is important, as it translates into efficiency and tells you that they will be comfortable navigating the particular waters you’re entering together. After all, the point is for the partnership to make your operations smoother, and for that, you need a partner with relevant experience.

What Are The Top CROs in 2022?

The contract research organization (CRO) industry is rapidly growing, and it's easy to see why due to the unique roles they fulfill in pharmaceutical and biomedical research.

We’ve curated a list of the top 5 contract research organizations (CROs) in 2022:

IQVIA is a leading healthcare technology company providing integrated services spanning the entire healthcare and clinical development spectrum. IQVIA offers solutions for clinical trials and research/development, real-world evidence studies, safety and regulatory compliance, and commercialization, and features a vast suite of technological tools powering “smarter healthcare.”

2) Labcorp Drug Development

Labcorp Drug Development, formerly Covance, is a contract research organization that offers drug development, clinical trial, and laboratory services to the pharmaceutical industry. The company's mission is to help advance patient care by providing clients with high-quality services and solutions.

Labcorp was founded in 1996 and has since grown into one of the world's largest CROs, with over 40 offices worldwide.

PPD is part of Thermo Fisher Scientific, serving as the clinical research services arm of the research giant. PPD is known internationally, having conducted clinical trials in over 100 countries, and currently consisting of over 35,000 employees worldwide.

PPD offers a comprehensive range of clinical development and laboratory services, providing sponsors with customizable solutions backed with a proven track record of professionalism and success.

ICON plc offers a full range of consulting, clinical development, and commercialization services to pharma, biotech, and other healthcare sector actors. Founded in Dublin, Ireland in 1990 and now counting on offices in 46 countries worldwide, ICON has a global team of experts and extensive experience in a wide range of therapeutic areas.

Medpace provides full-service clinical development services aimed particularly at biotech firms, with services ranging from study start-up through to monitoring, pharmacovigilance, regulatory affairs, and even medical writing. Founded in 1992, Medpace now operates in 6 continents and their teams of medical, operational, and regulatory specialists support their “therapeutically-aligned” scientific expertise and the delivery of their full-service, solution-oriented trial execution model.

CROs have become ubiquitous in clinical research amidst the trend toward partnering with third-party providers and the rise of specialized end-to-end clinical development services. A well-equipped CRO will be a valuable ally in managing drug development and clinical trial operations, bringing expertise and experience as well as access to state-of-the-art technology and facilities. Often, partnering with a CRO means optimizing resource allocation and thus keeping costs down. If you’re considering partnering with a CRO to enhance your research, development, or clinical trial efforts, it’s important to make an informed decision to ensure your operations are in the right hands. If you’re looking for a partner specializing in modern patient recruitment, reach out to us – we will be happy to show you the incredible power that lies within our patient recruitment marketplace and advanced recruitment solutions.

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People. value. research..

Clinical Research Organization: Our commitment is to enhance global health by prioritizing people and pioneering patient-centric clinical research worldwide. ‍

PVR is an agile and patient-centric CRO with global reach and focus on Real World Data

More and more clinical trials fail to meet key targets. Declining patient recruitment, engagement and retention result in insufficient or low-quality data, causing delayed or unsuccessful market authorization. PVR’s agile capabilities enable end-to-end quick project design, focusing on patient centric services and real world data solutions that contribute to the clinical trial and market success.

What is PVR?

PVR is a nimble and patient-focused Clinical Research Organization (CRO) boasting global reach and a specialization in Real-World Data. In an environment where numerous clinical trials struggle to meet critical targets, issues like dwindling patient recruitment, engagement, and retention often lead to insufficient or subpar data, causing delays or even failure in securing market authorization. Leveraging our agile capabilities, we offer end-to-end rapid project design, centered on patient-centric services and real-world data solutions. This approach significantly contributes to the success of both clinical trials and market approval processes, positioning PVR at the forefront of global clinical research advancement.

Clinical Research Organization (CRO): How they work?

• Author Company: Clariwell Global Services
• Author Name: Zain Malik
• Author Email: [email protected]
• Author Telephone: +917709551477
• Author Website: https://www.clariwell.in/best-clinical-research-courses-in-pune-with-100-percent-job-guarantee

A clinical research organization (CRO) is often called a contract research organization (CRO). CRO is a service organization that provides support to pharmaceutical and biotechnology industries in the form of outsourced clinical research courses and services for both medical devices and drugs.

The main functions required to conduct clinical researches, which are usually departments of the clinical research organization, are:

• The function of medical operations: People working in this area are given clinical research training from various clinical research institutes. This sector includes medically qualified people who are capable of constructing and designing clinical studies, clinical trials, and their protocols to provide medical-related input throughout the study. This includes roles like medical monitor, clinical research physician, advisors, etc.
• Clinical operations: This is the most organized and the largest team in any contract research organization. It consists of medical research associates, clinical trial assistants, managers, etc. This is the team of the CRO, which selects the clinical trial sites and locations, assists the studies, monitors the studies, etc.
• Data Management: This team helps in managing and designing various tools and databases. This is done in order to collect data from the trial. They help in ensuring that the data collected from the trials is accurate and is suitable for analysis. To keep track and organized, this team uses sophisticated software and modern technologies.
• Biostatistics: This team plays a major role in the outcome of the trial. They help in analyzing the study data and figuring out whether the study has yielded positive results or negative results while adhering strictly to all the protocols. They also generate statistical tables, figures, and graphs with their interpretations which are all then passed down to the medical writers to compile into reports.
• Writing team: these writers compile all the data into medical reports that can easily be understood by the public as well. They also manage the study protocols, study analysis reports, promotional material, etc.
• Quality assurance: The audits to ensure that the guidelines, standard operations, and regulation procedures are followed throughout are assessed by these trained professionals. This department is entirely dedicated to ensuring the quality of the product.
• Human Resources: Every clinical research organization has a dedicated human resource organization that is responsible for hiring trained professionals for various job roles and positions within the organization. They have to maintain a certain level of talent in the talent pool available.
• IT team: This is generally considered to be the support staff of the Clinical research organizations. They take care of all the IT-related needs like maintenance and purchases of laptops, desktops, telephones, software, etc.
• The finance team: All the monetary controls and the finance part, including the administration of the whole CRO, is managed by this department of the CRO.
• Training and Development: This is a dedicated department to training and developing in the CRO. It focuses on the professional development of all its employees and conducts routine training to make sure that their staffs remain up to date with all the developments in technology. It acts as a clinical research institute that provides the best clinical research courses and clinical research training .

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List of Contract Research Organizations in United States

Featured cros.

SanaClis is a full-service Global CRO with a fully integrated clinical supply chain, thereby offering a comprehensive range of end-to-end services for clinical trials. SanaClis was founded in 2000 by seasoned industry experts, all of whom have had ex...

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec...

ProRelix Research

Since 2014 ProRelix Research has been supporting our clients with outstanding clinical research services. The successful growth of ProRelix Research has been achieved by putting high quality and client focus at the heart of everything we do.We levera...

Atlantia Clinical Trials

Atlantia Clinical trials is a world-class provider of human clinical studies. For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maint...

Local, small- and mid-size Contract Research Organizations in United States

A10 Clinical Solutions (A10) helps its clients get their life-saving, innovative, investigational new drugs to market faster and safer by the quality management of critical clinical trials. A10 is known for its outstanding thought-leadership and is o... View full profile

• United States

Aagami, Inc. is a life sciences consulting firm based in the suburbs of Chicago which offers, Strategic Consulting Services Business Development support in regions where you are unable to reach out due to bandwidth Technology Licensing Se... View full profile

Our mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. Absorption Systems was Established in 1996 Absorption Systems develops a... View full profile

AES owns a proprietary database containing fully identified patient data. And we own a global site conduct organization. Put them together and you get a unique solution for global patient delivery that offers certainty of budget, time, speed, and qua... View full profile

We are a full-service clinical CRO with a relentless mission to complete your clinical trial on time. Backed by our strong operational strategy and leadership, a devoted team of medical professionals in each country and connections to prominent medic... View full profile

Accelsiors is a scientifically-driven CRO committed to serving the needs of its Sponsors with the highest level of quality. We provide a full array of services and pride ourselves on having ready access to treatment naive patient populations. From co... View full profile

Accumedix Mission Accumedix Develops and Commercializes New Medical Device Technologies. We intend to generate an excellent return for our investors by providing outstanding value for our customers. We will continue to grow the company through const... View full profile

Since our inception in 2001, ACI Clinical has been providing timely, unbiased, actionable medical/safety/data guidance and decision support tools to mitigate risk and ensure patient safety in clinical trials. ACI provides this timely oversight and gu... View full profile

Actimus Biosciences as a knowledge based CRO, was established in the year 2005. The facilities are located in Visakhapatnam, Andhra Pradesh, India. We pride ourselves by providing most reliable and quality services to pharmaceutical companies in thei... View full profile

ABL provides contract manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. ABL combines its expertise in translational science together with operational excellenc... View full profile

Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilen... View full profile

Telemedicine is revolutionizing the healthcare industry, improving access and reducing cost for patients and providers alike. With digital health technology more advanced than ever and virtual consults that put both parties face to face, telemedicine... View full profile

Albuquerque Clinical Trials, Inc. (ACT) We are a privately-owned, dedicated clinical research center specializing in Phase II-IV clinical trials for pharmaceutical and biotechnology sponsors. Founded in 1988, we have over 80 years of combined researc... View full profile

AlcheraBio is a Contract Research Organization (CRO) and animal health consultancy group. We are dedicated to helping companies achieve their clinical trial goals on time, within budget, and with high-quality data. We are proud to see that our work c... View full profile

The Alliance for Clinical Trials in Oncology seeks to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines, committed to discovering, validating and disseminating effective strategies f... View full profile

Allphase Clinical Research is a full-service, progressive, Contract Research Organization (CRO) providing high quality clinical development strategy and management services for early-stage to post-market programs. Allphase was founded with the mandat... View full profile

AGI has enjoyed tremendous success and growth throughout the years, and as we have grown, we have strengthened our dedication to providing only the best and most cost-effective research and development support to the scientific community. Each AGI em... View full profile

Amarex Clinical Research has extensive experience successfully performing clinical studies from across all phases of research and discovery, development, validation and approval. We incorporate scientific excellence and product development strategy i... View full profile

Our vision is for Anabase to provide the best resources, experience and expertise to companies of any size for their products to succeed in the market place by addressing the medical needs of patients and physicians around the world. Anabase aims at... View full profile

APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible. To achieve th... View full profile

• United Kingdom

Applied Biosystems instruments and reagents have been trusted in the lab for over 20 years by the world's top scientists. Researchers who demand efficiency, accuracy, and gold-standard technology use Applied Biosystems integrated systems for sequenci... View full profile

AHRM Inc. is a full service Contract Research Organization (CRO) with a focus in Health Outcomes and Health Economics Research. By providing the ability to integrate both clinical and economic research into one protocol or study, AHRM Inc. can suppor... View full profile

Absolute Research Solutions was created to assist pharmaceutical companies in the successful and timely completion of their trials. Through over ten years of clinical trials experience, our consultants have been involved in all phases of the drug de... View full profile

At Clinical Systems, Inc. we focus on producing clinical label products that meet the strict requirements of the pharmaceutical and biopharmaceutical industries and have led the way in innovations, accuracy and quality. We’ve developed the most power... View full profile

Atlantia Clinical trials is a world-class provider of human clinical studies. For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maint... View full profile

We are a Site Management Organization whose sole purpose is to support the successful outcome of all clinical trials. We are constantly striving to identify and recruit experts in the field of Clinical Research. Dedi... View full profile

Avail Clinical Research is a privately owned research facility, founded in 1998 in DeLand, FL. As an Accel Research Company, Avail and its sister sites (Achieve in Birmingham, Alabama and Accord in Port Orange, Florida) are supported by a strong infr... View full profile

Avitacor is a California-based company that specializes in providing management, marketing, sales and scientific expertise of CRO services to pharmaceutical and biotechnology companies. Avitacor has developed business alliances for the conduct of cli... View full profile

Axio is a premier provider of biostatistics and data management services to pharmaceutical, biotechnology, and medical device companies. We are focused exclusively on delivering timely, high-quality data and thoughtful analysis to help our clients de... View full profile

AXIS is an efficient, metric based clinical research provider with a global footprint of operations. Our mandate recognizes the need within the medical research community for quality clinical services backed by experience, ICH/GCP training, protocol... View full profile

Axon Medchem is a leading European service platform for medicinal chemistry, spinned-off from Axon Biochemicals BV. Together with Axon Biochemicals BV, it conducts business operations as a contract research organization (CRO) in medicinal chemistry.... View full profile

• Netherlands

Founded in 1974, Bioanalytical Systems, Inc. (BASi®) is a publicly traded, global company headquartered in West Lafayette, Indiana, that provides contract research services and sophisticated, niche instrumentation to the life sciences industry, prima... View full profile

We recognize that the most effective, motivating, and supportive participant engagement solutions are designed in partnership with health providers and always consider the needs of the patient. Our products and services inspire the whole study commun... View full profile

bioaccess™ is a contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of services from bench to commercialization. With bioaccess™,  medical device and biopharma companies will have long-... View full profile

At Barc Lab our work is about helping you succeed, yet we have a nice story to tell. Take a glance at who we are and what we do. The quality of life and the health of patients has always been our top priority. Our first customers were looking for a c... View full profile

Biomere is a global, nonclinical contract research organization (CRO) with locations on the east and west coast, as well as multiple locations in China (JOINN). In addition to our rapidly growing ocular research program and gene therapy expertise, we... View full profile

Thank you for visiting our website, and for your interest in learning more about our company. Biometrix was founded in 1994, with the goal of providing high quality instrumentation services at a reasonable price to the biotechnology, pharmaceutical a... View full profile

Biostat International, Inc. is a contract research organization based in Tampa, Florida. For 20 years, BSI has met the needs of device and pharmaceutical companies by providing research services. In 2011, BSI launched rED Cap, a web based electron... View full profile

Welcome to the Biotrial website, where you will find extensive information on the services we offer, on our expertise and experience, and of course on how to contact us. At Biotrial, drug evaluation and pharmacology research is a tailor-made service.... View full profile

Blue Sky BioServices, founded in 2003 to serve the Boston area life sciences research hub, is now the leading Contract Research Organization (CRO) providing Gene through Screen services to the global biotech, pharma, and academic R&D market. Our... View full profile

Boston MedTech Advisors provides comprehensive and practical business services leveraging its Principals and other Team members' unique perspective of the medical technology and healthcare industry and their understanding of the challenges companies... View full profile

At Bracane, we offer comprehensive program evaluation and research operation support services through a customer-focused approach. Our dedicated teams prioritize timely completion and staying within the customer's budget. We specialize in market, con... View full profile

For almost two decades Bradstreet Clinical Research has provided clinical research and regulatory affairs services to pharmaceutical, medical device and medical education companies. Our clients consistently compliment us for being an outstanding serv... View full profile

Bright Pharmaceutical Services is a privately-held full-service Contract Research Organization that was founded in 2002. Our clients range from small startups to the largest pharmaceutical, device and biotech companies, as well as government entities... View full profile

Burleson Research Technologies (BRT) is a Contract Research Organization (CRO) in the Research Triangle Park area that provides laboratory services to clients from the biotechnology, pharmaceutical, chemical manufacturing, and health care industries... View full profile

C&R Research, first CRO in South Korea since 1997, has partnered with Korea's health and medical industries in clinical development for the past years.We are the Global End-to-End Service Provider, supporting the new drug development process to i... View full profile

• South Korea

Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes. By assessing the scientific, medical, regulat... View full profile

Cambridge Biomedical Has You Covered From assay development to clinical sample testing, our services are as dynamic as they are dependable. We work across a wide range of therapeutic areas and technology platforms to support all aspects of clinical t... View full profile

Our name combines these ideas. As the world’s #1 drug development, delivery and supply partner with over 80 years of experience, we are the catalyst for your success. We have helped thousands of innovators by optimizing and manufacturing thousands of... View full profile

CCS Associates, Inc (CCSA) is a woman-owned, small business providing leading-edge scientific advisory services in pharmaceutical and device discovery and development to government agencies as well as the pharmaceutical and biotech industries. 30 yea... View full profile

Certus' mission is to provide outstanding quality and high value clinical trial management, monitoring, data management, regulatory, biostatistical, writing and imaging core lab services within the pharmaceutical, medical device, imaging (MRI, CT, X-... View full profile

ChemDiv, a fully Integrated Target-to-Clinic Contract Research Organization (CRO) headquartered in San Diego, CA USA, has been a pioneer in discovery libraries since 1991. Its first diverse heterocyclic compounds collection was compiled from academic... View full profile

ClinAudits assists clients in the pharmaceutical, biotechnology, biologics, gene therapy, tissue engineering, and medical device industries to meet FDA and other regulatory agencies compliance requirements, both domestically and internationally. We a... View full profile

ClinDatrix, Inc. is a privately held, full-service CRO founded in 2002 to help drug and medical device innovators advance their therapeutic products toward regulatory approval. Over the past decade, ClinDatrix has grown to offer contract research exp... View full profile

Diverse Experience = A Stronger Partnership Our team has experience in every phase of Clinical Research projects. Our employees have worked at large Contract Research Organizations, Pharmaceutical companies and as independent contractors. Clinfinity... View full profile

A singular focus on clinical research With 20 years of continuous operations dedicated to clinical trials, you can trust us to expertly design and manage your most complex study. Our study experience includes both domestic and international trials. W... View full profile

We were founded in 1990, before the device industry knew it needed a consultant in clinical research, and we claim to be the oldest medical device CRO in the States. Today Clinical Device Group we offer consulting, contracting, and rich-content train... View full profile

Providing regulatory and clinical trial services to medical device companies internationally in accordance with FDA and ISO standards. View full profile

CRMG is a nimble clinical development services organization, focused on providing biotech and pharmaceutical companies with an assortment of capabilities tailored to support clinical development programs and studies from Phases I – IV. Our organizati... View full profile

CSSi was founded in 2005 as Clinical Site Services to serve individual sites with their patient recruitment needs, later expanding into a major global centralized patient recruitment company. A leader in the industry, CSSi delivers strategic patient... View full profile

We are a premier full-service CRO that provides clinical development services to pharmaceutical, biotechnology, and medical device companies. Our mission is to provide high quality, prompt, and cost-effective clinical drug development services to our... View full profile

CliniRx is a full service mid-size CRO that provides comprehensive end- to- end solutions for clinical studies. CliniRx’s services include Phase II –III and late Phase (Phase IV) across numerous therapeutic areas and specialties.These specialty areas... View full profile

Trial sponsors work with ClinSmart because we have a track record of success, and a team of individuals that value trust. We leverage our local presence to build strong trust and communication with biopharma teams in the region. Learn more about how... View full profile

Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS._x000D_ Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level... View full profile

Clintec, established for 21 years, is an innovative, medium-sized global functional services provider with a depth of expertise in oncology and rare diseases. Clintec combines the agility and flexibility typical of smaller CROs with the global covera... View full profile

Commonwealth Biotechnologies, Inc., was founded in 1992 to provide sophisticated research and development support services on a fee-for-service basis to the global biotechnology and pharmaceutical industry. Since 2004, CBI has pursued a strategy of a... View full profile

Comparative Biosciences was founded in 1996 to provide expert scientific resources and quality service to all sectors of the biomedical and biopharmaceutical community. We offer extensive experience in GLP and non-GLP preclinical toxicology, efficacy... View full profile

For nearly 30 years, Concentrics Research has been a leader in the conduct of Rx-to-OTC Switch and late-stage (Phase II-IV) research for the pharmaceutical, biotechnology, medical device, nutritional, and consumer healthcare product industries. In 19... View full profile

CPC works with hundreds of key opinion leaders both locally and around the world who function in a variety of roles including chairing and/or membership in Executive, Steering, Data Monitoring, Event Adjudication, and Entry Criteria Adjudication Comm... View full profile

The CRO Group is a leading global consulting organization and service provider. We specialize in providing consulting services for Medical Device, In-Vitro Diagnostic, Over The Counter (OTC), Digital Health, Software as a Medical Device (SaMD), and W... View full profile

Cu-Tech, a full-service contract clinical research organization (CRO), is uniquely specialized in the development of products related to dermatologic disease, and skin care. We are pleased to offer our clients over a decade of experience in providing... View full profile

DAVA Oncology is a strategic consulting company which offers numerous products and services customized to fit biopharmaceutical drug development needs. View full profile

Davinci is a contract research organization specializing in preclinical animal studies. Our services include GLP and non-GLP materials testing (for acute or chronic timelines), procedure and model development, and preinstrumentation of models. Our cl... View full profile

We are a renal research site network with a  spectrum of services for clinical drug research and device development. For 30 years we have helped 500+ clients with their development projects. From centralized research services in an integrated, coordi... View full profile

DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical... View full profile

DSP Clinical Research is a specialty Contract Research Organization (CRO) dedicated to the management and execution of Phase I – IV clinical studies. We drive top-tier success for small to mid-size pharmaceutical, medical device, and biotechnology co... View full profile

Edinger Medical Group is committed to providing exceptional healthcare to patients throughout Orange County. With offices in Huntington Beach and Fountain Valley, Edinger physicians specialize in Internal Medicine, Family Medicine, and Pediatrics. Ca... View full profile

EGeen International, Inc. is a global, specialized, rapid-response Contract Research Organization (CRO). Our business is to advance the drug development of biotech and pharmaceutical companies by offering fast, high quality and cost-effective clinica... View full profile

Delivering formulation development solutions, CGMP manufacturing, and comprehensive analytical services to efficiently navigate the drug development process. View full profile

Contract research - regulatory, clinical, post-market studies, product marketing -- for neurology, cardiology, endovascular, orthopedic. View full profile

Emissary International has been navigating the clinical trials process for over a decade, earning itself a second-to-none reputation with clients in the medical device, pharmaceutical, biotechnology and contract research organization (CRO) industries... View full profile

endpoint is the destination for people who are passionate about delivering the most innovative and high-quality IRT solutions for clinical trials. We find purpose through hard work and a commitment to excellence, resulting in a competitive advantage... View full profile

Excel Life Sciences (ELS) is a US-based, India-focused provider of comprehensive clinical trial management services. ELS is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and delivery... View full profile

Fast-Track Drugs and Biologics, LLC is a contract research organization (CRO) providing strategic planning, clinical trial and regulatory support services to the pharmaceutical and biotech industries for the development and licensure of vaccines and... View full profile

FEFA is an ISO 9001:2015 Certified Corporation. We have established a process for meeting and exceeding the expectations and requirements of our clients. We also have a program to evaluate the quality of the services we provide. This enables FEFA to... View full profile

We are a CRO providing integrated, scientifically-driven research, analytical and development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We have enable... View full profile

GenesisCare Clinical CRO is an independent company founded by GenesisCare, with people skilled across the full spectrum of traditional CRO service offerings yet connected through GenesisCare to additional research services and investigator sites. Why... View full profile

Genialis is a data science and drug discovery company focused on new ways to treat disease. Blending computational biology and AI-based methods, Genialis merges and models data at the intersection of clinical and translational medicine. Genialis is t... View full profile

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. GenScript’s businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and syntheti... View full profile

Global Drug Development (GDD) Experts is the Site Management Organization (SMO) of choice in India. GDD is a US-based company, and brings global expertise in quality assurance and patient enrollment to the Indian SMO market. Unmatched in therapeutic... View full profile

Today, Grayline is recognized as a premiere clinical trial research facility. The company and its staff bring to each clinical trial a formidable body of experience and expertise. That collective experience covers a wide range of research designs, ta... View full profile

Our physicians and staff bring more than 40 years cumulative clinical research experience to our Naples, Florida facility. Our facility is under the directorship of a principal investigator with over 28 years of clinical research experience, most of... View full profile

GVK BIO, a leading Contract Research & Development Organization – CRDO that services the global Biopharma industry; is headquartered in Hyderabad, India with operations in four sites including California, USA. Established in 2001, GVK BIO has ove... View full profile

Han Bo Rui Qiang (Shanghai) PharmaTech Ltd（US subsidiary: H&J CRO International-New York LLC） is a small Full-Service CRO in China yet ambitious to provide global clinical trial solutions. It was founded by Professor Fanqiang MENG in 2003 and h... View full profile

Health Decisions is a full-service CRO specializing in clinical studies of therapeutics for women’s health indications and studies of diagnostics for all therapeutic areas. Health Decisions has focused on women’s health since its inception more than... View full profile

The Helix3 team has been consistently working together since 1994 developing new methods and conducting GLP studies for regulatory submissions.  We are committed to providing innovative solutions with an unmatched focus on quality, flexibility and at... View full profile

Founded in 1947, Hill Top Research is one of the world’s leading clinical research services companies with centers in the United States and Canada. Hill Top Research provides clinical trial services in Dermatology Rx and efficacy/safety studies for t... View full profile

About HIMSS SoCal The Healthcare Information and Management Systems Society (HIMSS) was organized in 1961 as the Hospital Management Systems Society (HMSS), an independent, unincorporated, nonprofit, voluntary association of individuals. HMSS was fo... View full profile

Hurley Consulting Associates Ltd. is an international consulting company serving the health sciences industry since 1987.  With unique expertise to prepare datasets, reports, global regulatory submission documents and dossiers, Hurley Consulting inte... View full profile

Hyperion provides diverse services from in-house research and laboratory capabilities to program management and administrative support for government customers View full profile

ICTS is a clinical trials support company that specializes in achieving superior results in research studies by building and maintaining stronger connections throughout the entire clinical trial process. Our innovative and customized communication mo... View full profile

From site startup to study closeout (and everything in between), Imperial is ready to put 75 years of global operational expertise to work for you. We deliver all of this with a professional, personal touch, and a positive, hassle-free experience. View full profile

InClin is a full service Contract Research Organization with offices in the San Francisco Bay Area and Sydney, Australia. We are a single source provider of an integrated full suite of clinical development services from Phase 1 through Phase 4, inclu... View full profile

Innovate Research stands as a leading Contract Research Organization (CRO) dedicated to providing comprehensive services in the dynamic field of clinical research, established in January 2014 With a strategic presence across the globe, our offices ar... View full profile

• United Arab Emirates

Innovative Clinical Concepts (ICC) is a woman/minority owned clinical trials Research Service organization that provides specialized services to study sponsors/CROs. Our primary focus is to work with physicians and clinical practices who serve minori... View full profile

Insearch was incorporated in 2008 as a clinical business development company. Owned and operated by long-term industry experts, it is our mission to bring clinical expertise to our client sites while nurturing relationships with our Pharma and CRO pa... View full profile

Integrated Clinical Research is committed to provide comprehensive care with the most advanced technologies and services. The center conducts Phase I through IV pharmaceutical and medical device research. Founded in 2004, Integrated Clinical Research... View full profile

Founded in 1998 by visionary clinical research thought leaders, Integrium is a full-service Clinical Proof of Concept (PoC) firm that specializes in a wide range of therapeutic areas including cardiovascular, metabolic disease and dermatology researc... View full profile

Intermountain Allergy & Asthma has a long standing reputation of excellence in serving our Wasatch Front communities for well over 30 years. Our conveniently located offices in Draper and Ogden provide a wide range of Allergy and Immunology servi... View full profile

International HealthCare (IHC) is a full service contract research organization (CRO) and product development company providing clinical trials and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. View full profile

The International Pharma Trials group is committed to the highest standards of clinical excellence and scientific expertise. View full profile

InrexTest facilitates and coordinates pharmaceutical and medical device studies through our team of internal experts coupled with top quality labs supporting preclinical and clinical testing at every stage of development. At InrexTest, we understand... View full profile

As a full-service medical imaging core lab, we provide comprehensive services in support of Phase I-IV Clinical Trials and Class I, II, III Medical Device Trials. View full profile

JRF Global offers comprehensive non clinical GLP research services for regulatory submissions, worldwide. We offer fast, transparent, cost-effective, and hassle-free services in Toxicology, Eco-toxicology, Chemistry, Environmental Fate and Metabolism... View full profile

Founded in 2004, JANIX is an efficient, metric based clinical research organization (CRO) with a global footprint of operations including North America, Europe, Israel, Africa and Asia Pacific View full profile

Contract Research Organization View full profile

Kriger Research Group International provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US, Canadian, European and multinational pharmaceutical companies. KRGI is your way to... View full profile

Labnetworx is a consulting company that operates at the interface of Healthcare, Life Sciences, Pharmaceuticals and Information Technology. We offer our customers solutions designed to meet the needs of today and tomorrow.... View full profile

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) a... View full profile

Laxai Life Sciences Pvt. Ltd. was established in the year 2007, with a vision to accelerate the discovery chemistry campaign of global pharmaceutical companies, by supporting the high quality intended compounds in reduced pricing and timeline. With t... View full profile

Libra Medical, Inc. was founded in January 2007 as a full Contract Research Organization (CRO) providing innovative solutions to the Regulatory Affairs, Clinical Research, and Quality Assurance functions within life science companies. Our clients inc... View full profile

LifeTree Research is committed to continuing research on various diseases that are greatly impacting people globally. View full profile

Linical and Accelovance have merged to create a market-leading, midsized, global contract research organization (CRO) with a significant footprint across North America, Europe and Asia-Pacific. As the next step in the merger, Accelovance has incorpor... View full profile

Led by Chief Scientific Officer Dr. Neil Singla, Lotus Clinical Research has assisted in the delivery of hundreds of innovative solutions for patient care in pain management since 2001. Learn more about our mission, our team, and the impact our analg... View full profile

Clinical Maestro is a revolutionary platform of modular and integrated business applications. It enables all participants in clinical trials, Sponsor Companies and Service Providers, to plan studies, model and manage clinical contracts in an entirely... View full profile

Our scientists are trained in the fields of cell biology, molecular & micro biology, immunology, biochemistry, and often have multiple years of experience in a related field other than what was their degree research. The expertise gained througho... View full profile

Maya Clinicals is a Northern California CRO with an extensive network of sites, MD’s, and specialists in India. We are focused on working with Bio-Pharma start-ups and Pharma companies in a unique and flexible co-development model to accelerate drug... View full profile

MCRA is the leading industry-specialized, multi-service, employee-based, integrated business that assists clients in the entire technology life cycle, from research and development, through commercialization. Our team provides services to a wide rang... View full profile

MD Biosciences is an industry-leading provider of preclinical, translational and clinical-phase contract research services for the development of pharmaceutical and diagnostic assets. Established in 1991, MD Biosciences offers expertise, services and... View full profile

• Switzerland

Medelis is a full service oncology clinical research company. We provide sponsors with a highly-skilled and proactive oncology clinical trial management team to design and manage phase I through phase III oncology trials in North America and Europe. View full profile

Mediconomics provides spot‑on professional CRO services. Mediconomics is a successful CRO and consultant for research and development projects of both Medicinal Products and Medical Devices. Headquartered in Hannover, Germany and with subsidiaries... View full profile

MedSource provides support for complex clinical trials with expertise in complex therapeutic areas such as oncology, neurology, and rare diseases and complicated study designs from first- in- human dose escalation to adaptive designed registration st... View full profile

As a contract research organization, MedTrials serves as a provider of specialized clinical research services ranging from clinical trials consulting, project management and monitoring, data management, biostatistics and auditing to providing industr... View full profile

MicroConstants Overview: We are a GLP-compliant Contract Research Organization focused on performing bioanalysis, drug metabolism, and pharmacokinetic analysis in support of new therapeutic development programs. We specialize in method development, v... View full profile

MMS is a place where years of proven success have guided sponsors through their data services and regulatory submissions goals. When MMS takes on a project, colleagues become ingrained in that sponsor – taking on a greater level of care and guiding t... View full profile

In today’s increasingly complex clinical development environment, life sciences companies are faced with pressures from regulators, payers, and the public to manage clinical trials that are safe, cost-effective, and informed by big data and technolog... View full profile

NCGS INCORPORATED, FOUNDED IN 1984, IS INTERNATIONAL, FULL-SERVICE CRO THAT SPECIALIZES IN CONDUCTING AND MANAGING CLINICAL TRIALS View full profile

North Carolina Clinical Research (NCCR) is an independent, multi-therapeutic outpatient clinical research site located in Raleigh, North Carolina. NCCR has conducted Phase I, II, III and IV clinical trials in both children and adults since 1986. We h... View full profile

Our practice philosophy is an extension of the philosophy of life that we share. We love our roles in research and development, as well as, the advancement of medicinal therapies. We have been blessed with a great staff and countless opportunities to... View full profile

Norwich Clinical Research Associates Ltd. (NCRA) has been providing quality clinical research services since 1994. Our primary product is the completion of clinical research projects accurately and cost effectively. NCRA offers competitively priced c... View full profile

Novatia, LLC is contract research organization providing products and services based on years of industrial scientific experience with analytical methodologies and pharmaceutical development. View full profile

Count on us to handle the details, so you can focus on quality care. For post-acute or senior living residents who rely on your experienced staff to help manage their medications or do it themselves we offer cost-effective, best-in-class pharmacy ser... View full profile

Oncotherapeutics offers a comprehensive service portfolio that supports preclinical studies and clinical trials from phase I to IV. We strive to provide high quality deliverables and our clients, from small start-up biotech (16-50 employees) to large... View full profile

Ora is the world’s leading full-service ophthalmology CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, we helped our clients obtain 46 approved and marketed products. We support... View full profile

Orbis Data Solutions, a specialized clinical consulting and contract staffing firm, provides Clinical Data Management and Biometric expertise to pharmaceutical, biotechnology and medical device companies nationwide. Orbis Data leverages its Biometric... View full profile

Navigating the CRO landscape can be difficult for biotech companies that vastly rely on outsourcing as the differentiation between CROs seems marginal and confusing at times. Orphan Reach is different: We are a boutique service provider solely focuse... View full profile

Outcome Health is a healthcare innovation company reinventing the point of care to facilitate better outcomes for patients, their loved ones, and healthcare professionals. Through partnerships with nonprofit organizations, health advocacy groups, lea... View full profile

In 1972 Mart Spalding Sr. founded Northview Biosciences. Pacific BioLabs was founded in 1982 as Northview Pacific Labs (NVP), the West Coast division of Northview Biosciences, Inc. CRO Supporting the Growth of Biotech NVP was opened to help Northvi... View full profile

Pacific Biomarkers is a biomarker testing services provider, supporting pharmaceutical, biotech and in-vitro diagnostic (IVD) manufacturing companies through preclinical and Phase I-IV studies of drug and IVD development. Pacific Biomarkers has an e... View full profile

Pacific Bridge Medical has 30 years of experience with business development and regulatory affairs in the Asia markets. We focus only on Asia, and we know it well. Our consulting services can help at any stage of your business, with everything from... View full profile

Palm Beach CRO is a full-service boutique Clinical Research Organization (CRO) that is devoted to small to mid- size pharmaceutical, biologics, generics, vaccines, medical food and consumer healthcare companies with broad range of clinical research s... View full profile

When you need to find qualified patients for clinical trials, it's easy to get lost in the process. Mapping out a direction and taking the right path is critical. That's why The Patient Recruiting Agency™ (TPRA) is here. We are metrics driven and our... View full profile

PaxMed International is a leader in regulatory affairs for the medical device industry. We work with medical device manufacturers of all sizes, providing the expertise required to rapidly bring to market emerging technical innovations. View full profile

Peachtree BioResearch Solutions is a full-service Clinical Research Solutions Organization that specializes in providing clinical development services to biotechnology, pharmaceutical, and medical device companies – focusing on emerging to mid-sized... View full profile

Pharm-Olam (is now Allucent) is a mid-size global full service contract research organization (CRO), founded in 1994, and over time, we have established a strong reputation of performing exceptionally in challenging international clinical trials. Our... View full profile

Pharmaffiliates Analytics and Synthetics P. Ltd., a Research Based Organization is a gigantic name in the global market, which offers services to Pharmaceutical industry, Biotechnology industry, API manufacturers, Bulk drug suppliers, clinical CROs,... View full profile

Founded in the US state of Delaware in 1997, PharmStats Ltd. is a professionally specialized Contract Research Organization (CRO) with rich experiences providing statistical and clinical support for clinical trials and pharmaceutical development pack... View full profile

Our mission is to conduct safe, ethical, and successful trials that exceed the expectations of participants and sponsors alike. Through our work, we seek to increase the wellbeing of others, bolster medical progress, and continue to be a good member... View full profile

Since opening our doors in 2002, our approach to patient recruitment is what has set us apart. A focus on providing a unique, customized program for each and every clinical trial we undertake – along with superior service delivered by a highly respon... View full profile

Prelude Dynamics is a global provider of customized web-based Clinical Trial Management Solutions and Services. We offer unique, innovative research and clinical solutions to all areas of the pharma industry, world wide. View full profile

With a track record of more than three decades working with industry leaders, mid-size and start–up companies, Promedica International (PMI) can support your clinical research projects with a wide range of specialized clinical study services, includi... View full profile

PROMETRIKA, LLC is a clinical research organization (CRO) supporting the biopharmaceutical and medical device industries since 2003. Based in Cambridge, Massachusetts, a biopharmaceutical hub, PROMETRIKA has provided more than a decade of experienced... View full profile

Since 2014 ProRelix Research has been supporting our clients with outstanding clinical research services. The successful growth of ProRelix Research has been achieved by putting high quality and client focus at the heart of everything we do.We levera... View full profile

Integrity. Quality. Excellence. Since our launch in 1996, we have been driven by a shared commitment to providing outstanding service in the world of clinical research. And to this day, that commitment remains our guiding principle. We opened our doo... View full profile

At Providence Clinical Research, patients volunteer in clinical trials and help to develop the medications of tomorrow. Our physicians carefully monitor our patients' health while they test these medications for drug manufacturers and the Food and Dr... View full profile

Quantum Solutions India (QSI) is now part of the PAREXEL family of companies. The acquisition of QSI strengthens PAREXEL’s capabilities in outsourced safety management solutions, providing a more comprehensive, efficient, and economical solution to c... View full profile

Pharmaceutical Studies PreviousNext Quantum Laboratories, Inc. is a Florida corporation dedicated to providing professional CNS clinical research services to the pharmaceutical industry and to patients that we serve. Quantum Pharmaceutical Research... View full profile

Quartesian LLC was formed in January 2003 and is headquartered in Princeton, N.J. with the goal of providing world-class clinical development services to its clients. This goal is accomplished by adhering to the founding principles of excellence, int... View full profile

A Passion for Bio-specific Artificial Intelligence (BioAI™) Understanding the biomedical literature and other text content is critical to the $5T healthcare industry. Traditional approaches are not able to deal with the volume of data and eliminate t... View full profile

QPS is working as a contract research organization (CRO) in close collaboration with a large international network of scientists, investigators and professionals. We are operating from strategically located sites throughout Europe, the United States,... View full profile

Quorum Review IRB, the first name in streamlined, service-centered independent ethics and regulatory review, assures the ethical integrity of clinical research. With our partners, we advance the frontiers of medical innovation while sustaining the ri... View full profile

There’s been roller coaster changes in the healthcare economy over just the past decade. RCRI has been there providing accurate, efficient, and complex regulatory and clinical consulting services for decades. Our team continues transforming medical... View full profile

Cancer is one the top 5 diseases in the world. It affects many lives worldwide, and we intend to do much about it. Since 2006, Releaf Research, a woman-owned CRO, is known to for exceeding client expectations. We consider every study we support a pot... View full profile

Research Assist, is a boutique contract research organization (CRO) providing exceptional clinical research services to industry (pharmaceutical, biotech, and device) clients since 2000. Our seasoned staff of professionals are experienced in the mana... View full profile

Research Dynamics was founded in 1993 by Lorraine D. Ellis, MS, MBA. We have been providing clinical research services and training to the industry for over 20 years. Our staff of clinical research professionals is dedicated to providing the best in... View full profile

ResearchPoint Global is a full-service CRO with 15 global offices and clinical coverage in over 60 countries. Founded in 1999, ResearchPoint Global (RPG) is a worldwide clinical organization with more than 450 employees and coverage in over 60 countr... View full profile

Collaborating on all therapeutic modalities, Resolian fuses expertise from Alliance Pharma and Drug Development Solutions to provide world-class scientific solutions. View full profile

Clinical Research with Agility and Adaptability Rho is a full-service contract research organization optimally sized to deliver results from clinical research with agility and adaptability. Maximizing profitability, stability, and planned growth has... View full profile

Rxcel Partners is a consulting firm headquartered outside of New York City with consultants located in the Northeast, Southeast, Midwest and West, dedicated to providing the pharmaceutical, biotechnology, medical device and venture capital industries... View full profile

Schiff & Company, Inc., founded in 1982, specializes in full services to the industries regulated by the United States Food and Drug Administration (FDA) and similar agencies in other countries. Services provided include the preparation of regula... View full profile

By enabling scientists to easily Outsource Everything But the GeniusTM, we are pioneering a faster, leaner and more innovation-centric approach to research. Our vision is to create a world in which scientists are limited only by their imagination. Ou... View full profile

SEKISUI XenoTech is a specialty global Contract Research Organization (CRO) specializing in ADME/DMPK/DDI testing of potential drug candidates. Utilized by top pharma companies, biotechs, and numerous other organizations, we provide the finest tools... View full profile

Jeffrey Buell formed sequence Development in 2012 as a commercial real estate development firm pledging to take an atypical perspective to properties in the 21st century. Sequence approaches each project it undertakes with a focus not on the single b... View full profile

Through our strategic investments and partnerships, ShangPharma Innovation is focused on filling the critical investment gap that exists for earliest-stage therapeutic breakthroughs. Based in the San Francisco Bay Area, our experienced team of inves... View full profile

Sinclair Research Center is a privately owned biomedical research facility located in Central Missouri. Sinclair was formed in 1964 by the University of Missouri and originally named the Sinclair Comparative Medical Research Farm (SCMRF). Its primary... View full profile

Founded in 1925 and headquartered in Akron, Ohio, Smithers is a multinational provider of testing, consulting, information, and compliance services. With laboratories and operations in North America, Europe, and Asia, Smithers supports customers in t... View full profile

SMP is a small sized CRO with its main office in Brasov, Romania. Our main activity is to conduct clinical research in bioequivalence studies and clinical trials of phase II-IV in Romanian sites. Through our offices the SMP personnel provides full mo... View full profile

2017 marks the 60th anniversary of the founding of Shin Nippon Biomedical Laboratories. With decades of experience as a contract research organization, our team provides study data about the safety and efficacy of pharmaceuticals, which is essential... View full profile

In 1972, the Social Psychiatry Research Institute was established by two psychiatrists to support and conduct clinical research for antidepressant and anti-anxiety drugs. From our founding in New York over 40 years ago, SPRI has grown from a small ne... View full profile

Sofpromed is a full service Clinical Research Organization (CRO) specialized in the global management of phase I-IV clinical trials worldwide for biotechnology and pharmaceutical companies across all therapeutic areas. We manage clinical trials glob... View full profile

Sovereign Health of California provides treatment for alcoholism, drug addiction, mental health conditions and dual diagnosis (co-occurring substance abuse and mental illness). We offer residential and outpatient treatment programs for adolescents an... View full profile

With the most advanced technology; the integration of monitoring, recording, analyzing and reporting all in one place; and a unique specialization in cardiac safety testing for new drugs in development, we provide the highest quality results with the... View full profile

STATKING Clinical Services is proud of its over 30 year history of service to industrial clients. Since the company's founding in 1989, the company has evolved from providing statistical consulting and data analysis services on a variety of household... View full profile

STI Pharma, LLC, located in Newtown, PA, was founded in 2008 by a team of industry veterans. STI is a specialty pharmaceutical company focused on the acquisition, development and marketing of high quality prescription pharmaceutical products. Our pro... View full profile

Why Choose SRC? Whether you are a startup or a large multinational company, you can benefit from the experience and expertise of SRC to meet your objectives in a highly cost effective way. Experience SRC has a proven track record in drug, medical... View full profile

Our diverse company operates multiple types of healthcare services dedicated to improving the quality of care in a convenient and cost-effective manner. The support of our ancillary services is one of many unique attributes that differentiate us from... View full profile

Sylvana Research has been conducting research on investigational medications for approximately 30 years. We perform research studies year-round for indications such as allergies, asthma, hypertension and psoriasis. We are contracted by the Pharmaceut... View full profile

Headquartered in Port Jefferson, NY, Symbio is a client-focused global full service Clinical Research Organization (CRO). We manage all CRO core services in house and have our offices in the USA and Europe. We deliver excellent service and provide ex... View full profile

Established in 2008 by Pharma industry experts Technology driven organization with a flexible approach. Founded by scientists with proven industrial track record. Expertise in Process Research/Development and scale-up (non-GMP and cGMP). Research... View full profile

Synchron was started by a group of pharmaceutical professionals in 1998. Today Synchron is a leading Contract Research Organization in India providing broad range of clinical research services from phase I to phase IV, including : Bioavailability... View full profile

Sysdata is a USA based Contract Research Organization (CRO) formed in 2009. During the past few years, we have developed the health relationship with both big and small pharmaceuticals such as Pfizer, Amgen, Forest Lab, Biogen and Regeneron, etc. We... View full profile

Target Health Inc., a full-service CRO and Clinical Trials Software company, is committed, through creative collaboration, to serve the pharmaceutical community with knowledge, experience, technology and connectivity. Our pledge is to optimize the li... View full profile

Whether in the race of bringing that best-in-class treatment to patients or conducting post-marketing research to generate real-world evidence, you can count on Tech Observer to reach the goal. We can help in clinical operations, data management, sta... View full profile

TGA BioServices, an Absorption Systems company, is a contract research organization (CRO) providing the Pharmaceutical, Biotechnology and Academic communities a comprehensive range of laboratory services in support of basic research and development a... View full profile

Full-service CRO with an unwavering focus delivering high quality, on-time and cost-effective clinical research. While our impeccable reputation in anti-infective research and development has been at the core of our growth, we have extended that repu... View full profile

• South Africa

Therapeutics, Inc. designs, creates, and executes development programs for FDA registration of topical, oral and injectable dermatology drugs, biologics and devices. In addition to designing and managing Phase 1-4 dermatology studies, we maximize cli... View full profile

Incorporated in 1996, SIRO Clinpharm Private Limited is a Clinical Research Organisation supporting trials from Phase II to Phase IV and beyond post-launch of products. SIRO offers a range of services, from clinical operations to data services, data... View full profile

TKL Research is a fully integrated network of clinical research centers serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. Delivering results for over seventy years, we offer two purpose-built phase I clinic... View full profile

Dr. Hooper has several years of experience in primary healthcare in a rural setting from his practice of Emergency Medicine across the state of Mississippi. He received advanced training in science at LSU and was recruited to implement clinical mass... View full profile

We are Transcom Global, an ISO 9001:2015, ISO 17100:2015 and EN15038:2006 certified provider of translation, localization and QA services for the global life science industry. Our professional team understands your language and unique terminology. Fa... View full profile

 Specialist Pharmaceutical ConsultancytranScrip is a highly specialist pharmaceutical consultancy that provides strategic expertise, therapeutic experience and operational excellence across the entire product lifecycle, supporting clients globally.We... View full profile

We combine traditional western medicine with alternative care practices, blending the best of both worlds to provide our patients with the most effective treatment outcomes. Our mission is to improve your health from the inside out, while restoring b... View full profile

The US Oncology Network believes local cancer care is better care. We empower the delivery of advanced integrated cancer care through our network of independent physicians who share expertise and resources to provide quality, value-based care close t... View full profile

Vedic Lifesciences has been helping food supplement and ingredient companies substantiate health claims for North America, Europe and Asia for the last two decades. As a contract research organization (CRO), we have completed more than 400 clinical a... View full profile

For over 25 years, Versagenics staff have been leading innovators in the CRO industry. Our services allow clients to be proactive in managing their clinical development programs while maintaining constant and consistent contacts for all project relat... View full profile

In 1994, Vital Systems was built to accelerate clinical research services for emerging biotechnology, pharmaceutical and medical device companies. Vital Systems prides itself on high quality and responsive service that delivers intelligence from data... View full profile

Established in August 1988, Washington Biotechnology, Inc. (WBI) is located in Baltimore, Maryland, USA. WBI’s major service areas are: In Vivo Efficacy Testing of compounds and biologics over a wide range of disease models including inflammatory/a... View full profile

Dr. Schneider has worked in the pharmaceutical, biotech, and device industries for over 20 years. During this time she has worked in regulatory, risk management, product safety, medical education and communication, and marketing. Watermark is a priva... View full profile

Clinical Expertise to Fuel Your Study As a CRO specialized in early clinical development, we offer clinical trial services, overnight observation capabilities at our Phase 1 clinical site, and regulatory support. We utilize a collaborative approach w... View full profile

Westat began as a visionary startup in 1963. Now, 50+ years later with 1,900 employees, we continue to pioneer new ways to support the changing needs of clients. Our unique collaborative culture enables us to create dynamic multifaceted teams with br... View full profile

WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioe... View full profile

WuXi AppTec’s Laboratory Testing Division is a comprehensive and integrated testing platform for drug and medical device development. Fully integrated within WuXi AppTec, a world-class CRO with operations in China and the US, the Laboratory Testing D... View full profile

Our clinical team is committed to patient safety, study recruitment and excellent data. We are a comprehensive study team dedicated to the success of our trials, patient’s health and safety, and data integrity. ​Universal Research Group conducts and... View full profile

Global Contract Research Organizations in United States

Website: www.54gene.com  Email: [email protected]  Phone: +971 58 594 9926; +1 310-266-9926. 54gene’s Clinical Programs Group (CPG) is a contract research organization that provides innovative, customizable, and cost-effective clinical trials solutions... View full profile

Since 1975, ACM Global Laboratories has been a recognized leader in both medical diagnostic and global clinical trial testing services. With wholly owned facilities in New York, England, Shanghai China, Mumbai India and Singapore, we operate in more... View full profile

ACROSS Global is a unique, full-service, comprehensive alliance of qualified CROs and Specialist Service Providers dedicated to providing a professional, cost-effective, focused, and seamless service to the pharmaceutical, biopharma and medical devic... View full profile

• Bosnia & Herzegovina
• Congo, DR of
• Philippines
• Saudi Arabia

For more than 25 years, Aixial, the Contract Research Organisation (CRO) of the ALTEN Group, has been supporting pharmaceutical industry key accounts in Europe for various types of services: Insourcing & outsourcing. Aixial environments are vari... View full profile

• Czech Republic

Alcami is a world-class contract development and manufacturing organization (CDMO) with executive offices in Wilmington and Durham, North Carolina. Alcami is the first company to offer a solution that is tailored to small and mid-size pharmaceutical... View full profile

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and an... View full profile

ARENSIA Exploratory Medicine, a German company, specializes in "first-in-patient" Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure... View full profile

With 15 years of experience, we have defined a process that consistently achieves success for our clients.RESEARCH that uncovers the real needs and delivers actionable insights.At the heart of any healthcare challenge lies a compelling narrative. To... View full profile

BioReliance provides testing and manufacturing services to pharmaceutical and biopharmaceutical companies that span the product cycle from early pre-clinical development to licensed production. Our goal is to advance the development and delivery of h... View full profile

A global, full-service contract research organization. We take your trials personally. dMed Global, a full-service Clinical Contract Research Organization (CRO) based in Shanghai, China and Clinipace Incorporated, a full-service Clinical CRO with hea... View full profile

Cato Research is a contract research organization (CRO) that provides integrated services to pharmaceutical, biotechnology, and medical device companies. We specialize in complex development programs requiring innovative regulatory and clinical strat... View full profile

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. In Applied Translational Medicine, Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug a... View full profile

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work h... View full profile

Clinlogix provides the clinical, operational, regulatory, and niche therapeutic expertise — along with the passion, innovative spirit, and intellectual drive — that you need to fulfill the promise of your product. As drugs, devices, diagnostics, and... View full profile

Cmed specializes in complex disease areas, particularly oncology, immuno-oncology, cell therapy and other specialty therapeutics areas.Clinical trials in oncology, especially involving cell & gene therapy (e.g. CAR T cells) are increasingly compl... View full profile

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensi... View full profile

CrownBio brings clarity to drug discovery around the world by helping biopharmaceutical companies solve some of today's most pressing challenges in oncology, inflammation, cardiovascular, and metabolic disease Drug Discovery. Our premier Translationa... View full profile

Established in 1999, Cyprotex Limited was acquired by Evotec AG (www.evotec.com) in 2016. Cyprotex, an Evotec company, has sites at Alderley Park near Macclesfield, UK and in Watertown near Boston, USA. The company has dedicated and highly qualified... View full profile

Address: 603-7 St Thomas Street Toronto, ON M5S 2B7, Canadadicentra is a full-service Contract Research Organization (CRO) and professional consulting firm that specializes in addressing all matters related to safety, quality, and compliance for all... View full profile

Leveraging Science and Engineering to Accelerate Innovation When it comes to understanding the physical structure, chemical properties and performance of advanced materials and integrated circuitry, no other scientific services company offers the bre... View full profile

In clinical research, every detail matters. As trial complexity increases, new risks emerge. Missteps and inaccurate data can mean more expensive trials and delays in bringing life-saving treatments to the patients who need them most. We help you spo... View full profile

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies t... View full profile

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Global Clinical Trials, LLC is a full-service CRO with offices and operations in the United States, Europe and Asia. Our professional staff have been sharing their unique experience and utilizing established contacts with the key opinion leaders (KOL... View full profile

GreenLight Clinical is internationally recognised by sponsors and investigators as a Physician-led CRO of choice in Ophthalmic & Early-Phase Research. As a full-service CRO, we help customers bring innovative treatments and medical devices to mar... View full profile

HEMEX is a global provider of clinical research services to small and medium-sized life sciences companies in diverse therapeutic areas. By combining extensive clinical expertise, commitment to speed, and dedication to patient-centric approaches, HEM... View full profile

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of consulting, and outsourced developme... View full profile

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec... View full profile

IMS Health and Quintiles are now IQVIA, a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, m... View full profile

Keyrus Life Science is the C2RO launched by the Keyrus Group, the “Making Data Matter” company. Keyrus Life Science is a unique Connected Clinical Research & Development Organization. Keyrus Life Science helps connect industry expertise, Life Da... View full profile

MAC Clinical Research is one of Europe’s largest contract research organisations (CRO), committed to providing full-service delivery of global clinical studies. Headquartered in the UK with offices globally, we conduct studies both through our fully-... View full profile

MakroCare is expert strategic development and commercialization global partner for pharmaceutical, biotechnology and medical device industries. Our experience, programs and processes bring a new dimension to development strategy, regulatory/risk plan... View full profile

Medidee’s CRO (Clinical Research Organisation) services are backed up by decades of experience in the fields of medical device engineering, quality and regulatory affairs. This unique combination of all relevant competences supports all aspects of yo... View full profile

Our unique global partnering philosophy emphasizes an uncompromising commitment to clinical research and to the highest level of ethical standards and performance in our jobs. We are selective about the projects we engage in because we are devoted to... View full profile

NDA is a world leading drug development consultancy with a dedicated team of over 150 consultants supported by an expert network and a specialist Advisory Board. Our goal is to streamline drug development in order to accelerate patient access to impo... View full profile

Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional full-service CRO. With the increasing pace of globalization in drug development, Novotech’s expertise in the vibrant... View full profile

OCT is one of the leading Eastern European contract research organizations. Since 2005, we have conducted hundreds of clinical trials in Eastern Europe, in both CEE and the CIS. Our team of 200+ professionals provides a full range of high-quality CRO... View full profile

For over 35 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new produ... View full profile

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and go... View full profile

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic... View full profile

Our mission is to be the best CRO in the world as measured by our employees, clients, investigators, and vendors. Our teams work tirelessly to ensure that we deliver on time and on budget. You will always know what's going on with your study when you... View full profile

QPS was founded in 1995. Today, the company is considered one of the top CROs in the world. QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. QPS provides quality services... View full profile

Quanticate is a leading global data-focused Clinical Research Organization (CRO) which may also be known as a 'Biometric CRO'. Quanticate is primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing s... View full profile

We are the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. Our services range from routine blood tests — such as total cholesterol, Pap testing and white blo... View full profile

Rede Optimus is a medical device CRO with a global outreach to USA, EU and Brazil. Rede Optimus was founded by a group of  physicians dedicated to the medical device field which focusses on collaborative research and traditional CRO work. With our fo... View full profile

RTI Health Solutions is the place you turn when you need substantiated, authoritative evidence and advice. We are scientists first—academically-trained, credentialed researchers who know how and when to apply the appropriate research methodologies to... View full profile

SanaClis is a full-service Global CRO with a fully integrated clinical supply chain, thereby offering a comprehensive range of end-to-end services for clinical trials. SanaClis was founded in 2000 by seasoned industry experts, all of whom have had ex... View full profile

Life sciences services from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. There is no other area of business that is more heavily regulated than the development, testing and distribution... View full profile

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The best technology succeeds in the background. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eC... View full profile

Smooth Drug Development offers a full range of clinical development services in Europe and Asia (Baltic States, Belarus, Bulgaria, Hungary, Germany, Moldova, Russia, Serbia, Spain, Slovakia, India, Kazakhstan, Uzbekistan). It includes project managem... View full profile

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs a... View full profile

Synexus is a company dedicated to conducting clinical studies and have been investigating the effectiveness of new medicines and treatments for more than 20 years. We provide a friendly, relaxed environment where you have the chance to help shape the... View full profile

TAKE Solutions delivers domain-intensive services in Life Sciences and Supply Chain Management. In the fast-growing Life Sciences space, TAKE offers clients a unique combination of full-service Clinical, Regulatory and Safety services backed by uniqu... View full profile

Worldwide is the first customer-centric CRO. Founded by physicians dedicated to advancing medical science and built on an unwavering commitment to operational excellence, we are able to strategically balance science, medicine, operations, and commerc... View full profile

X7 Research is a new generation CRO providing a vast range of services in the EU, CIS, USA and Asia. X7 Research is a CRO of just the right size, where the clients’ needs are always first priority. As a result, 100% of our initial customers return to... View full profile

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Top 10 Contract Research Organizations (CROs) in 2024

Introduction  

Contract research organizations (CROs) play a significant role in ensuring clinical trials are run efficiently, ethically, and in compliance with ethical and regulatory requirements. The demand for clinical trials is growing, with recent analysis estimating the value of the clinical trials market to be US$84.7 billion in 2024 and projecting a compound annual growth rate (CAGR) of 6.49% to reach US$123.5 billion in 2030. Analysts identify increasing drugs in the pipeline and growing investment in pharmaceutical research and development (R&D) as growth drivers.     

To address changing market environments and the evolving needs of pharma and biotech companies, CROs have expanded their service areas to include innovations, e.g., decentralized trials, artificial intelligence (AI), and enhanced patient recruitment.  

To learn what our partners value most in CRO relationships, TFS HealthScience conducted a survey in 2023. Our partners seek quality of sites and patients, experience and capabilities, and connection in a CRO relationship.  

Let’s look at the top 10 CROs in the global clinical trials market and what sets them apart.  *The list of CROs is in no particular order.

1. IQVIA  

Founding Year : 1982  

Company HQ Location : Durham, NC, U.S.  

Founded in 1982, IQVIA provides advanced analytics, technology solutions, and clinical research services. It operates in over 100 countries and has approximately 87,000 employees. Leveraging its analytics, tech, big data resources, and domain expertise, IQVIA creates connections across different aspects of healthcare and helps accelerate clinical development and commercialization of innovative interventions. Solutions provided include R&D, real-world evidence (RWE), commercialization, safety and regulatory compliance, technologies, e.g., enterprise information management, performance management & insights, and provider reference data network. IQVIA has been recognized for its work, including the recent “Best AI-based Solution for Healthcare” award in the 2023 AI Breakthrough Awards.  

2. Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific, Inc.)  

Founding Year : 1985  

Company HQ Location : Wilmington, NC, U.S.    

Founded in 1985, PPD has grown from a one-person consultancy to a global CRO with more than 35,000 employees across 46 countries. PPD supports customers in conducting life sciences research and improving patient outcomes through diagnostics or therapies and has a track record of running clinical trials in over 100 countries. Services provided include clinical development, early development, peri- and post-approval, biotech solutions, functional service partnership solutions, laboratory services, product development and consulting, and site and patient-centric solutions. In 2021, PPD was acquired by Thermo Fisher Scientific Inc., a leader in serving science, committed to making the world healthier, cleaner, and safer. Thermo Fisher Scientific has received numerous accolades, including the most recent “Best Vaccine CRO of the Year” at the 2023 Asia Pacific Vaccine Excellence Awards.  

3. ICON plc  

Founding Year : 1990  

Company HQ Location : Dublin, Ireland    

ICON is a healthcare intelligence and clinical research organization. Headquartered in Dublin, Ireland, ICON has grown from a team of five in 1990 to approximately 41,150 employees in 106 locations across 53 countries. Clients include pharmaceutical, biotechnology, medical device, and government and public health organizations. ICON has been recognized for its strengths, including being one of Forbes World’s Top Companies for Women and the Financial Times Leaders in Diversity. Solutions include cardiac safety solutions, clinical and scientific operations, consulting, early clinical, laboratories, language services, medical imaging, site and patient solutions, strategic solutions, technologies, decentralized clinical trial solutions, and real-world intelligence.  

4. TFS HealthScience  

Founding Year : 1996  

Company HQ Location : Lund, Sweden  

TFS HealthScience (TFS) is a premier and innovative global mid-size CRO that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. With nearly 800 professionals and entities in North America, Spain, Europe, and Asia Pacific, TFS delivers tailored clinical research services in more than 40 countries.  

TFS offers comprehensive solutions, providing full-service support throughout the clinical development process, expert insourcing, targeted recruitment, and strategic workforce management solutions. Underlining its commitment to leveraging advanced technology for clinical excellence, TFS recently became the first CRO to adopt Medidata Detect , a data surveillance and risk monitoring solution that improves data quality and product development and promotes patient safety in clinical trials.  

For the fifth consecutive year, TFS received a Silver Rating from EcoVadis in 2024, placing it in the top 15% for sustainability excellence , a distinction that reinforces TFS’s commitment to corporate sustainability. TFS services include clinical development (Phase I – III, Phase IV & RWE), resourcing solutions, and functional services (FSP).  

5. Laboratory Corporation of America  

Founding Year : 1978  

Company HQ Location : Burlington, NC, U.S.  

Laboratory Corporation of America (LabCorp) is a global provider of innovative and comprehensive laboratory services supporting doctors, hospitals, pharmaceutical companies, researchers, and patients through its diagnostics and drug development lab capabilities. With more than 60,000 employees, LabCorp operates in over 100 countries and has performed more than 600 million tests for patients worldwide. It worked on over 80% of new drugs approved by the US Food and Drug Administration (FDA) in 2022. Last year, Labcorp was awarded the inaugural Forrester Research 2023 Customer Obsession Leadership Award.  

6. Charles River Laboratories International, Inc.  

Founding Year : 1947  

Company HQ location : Wilmington, MA, U.S.  

Charles River is steadfastly committed to collaboration, responsibility, and leadership within the global research community. From its beginnings as a one-person laboratory in Boston in 1947, Charles River has grown into a worldwide support network with over 150 facilities in 21 countries. The CRO has worked on over 80% of the FDA-approved drugs in the past five years. Clients include leading pharmaceutical, biotechnology, agrochemical, government, and academic organizations, while services range from basic research to drug discovery and development, manufacturing, and commercialization. Charles River was jointly named “Best Contract Research Organization (with NJ Bio, Inc.) at the 10 th Annual World ADC Awards 2023.  

7. Syneos Health ®    

Founding Year : 1998  

Company HQ Location : Morrisville, NC, U.S.  

Syneos Health ®  is a fully integrated biopharmaceutical solutions company that translates unique clinical, medical affairs, and commercial insights into outcomes to help clients address market realities. Bringing together professionals who work across more than 110 countries, Syneos Health ®  shares insights, uses the latest tech, and applies business practices to accelerate the delivery of important patient interventions. Solutions include clinical development (bioanalytical solutions, early phase, Phase II–IV, real-world and late Phase, decentralized solutions, site, and patient access), medical affairs, commercial delivery, and consulting. Syneos Health ®  has received recognition for its work, including the 2023 ViE (Vaccine Industry Excellence) Award and PM360 2023 Innovator in Clinical Trials.  

8. Parexel International Corporation  

One of the largest CROs worldwide, Parexel provides Phase I to IV clinical development services. From its inception in 1982, Parexel now has a team of more than 21,000 global professionals with expertise in clinical, regulatory, and therapeutic areas. Parexel conducted more than 360 clinical projects in the last five years and enrolled more than 114,000 patients. Among its accolades, it was named Best CRO in 2023 by an independent panel for Citeline and Top CRO to Work With by investigative sites worldwide. Solutions provided include portfolio management and asset valuation, early development and innovation, i ntegrated clinical development, approval and access, and value substantiation lifecycle management.  

9. WuXi AppTec, Inc  

Founding Year : 2000  

Company HQ Location : Shanghai, China  

Based in Shanghai, WuXi AppTec is a global company with a presence in Asia, Europe, and North America. WuXi AppTec supports the pharmaceutical and healthcare industry in advancing discoveries and delivering new treatments to patients while helping customers improve productivity. WuXi AppTec’s open-access and integrated platform supports clients through various stages of development and empowers the global healthcare sector to advance discoveries and interventions for patients. Services provided include chemistry drug CRDMO (Contract Research, Development, and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development, and Manufacturing Organization). Last year, WuXi AppTec was recognized by Frost & Sullivan as the 2023 Global CRDMO Company of the Year.  

10. Clinipace (Caidya)  

Founding Year : 2004  

In 2021, Clinipace and dMed merged, becoming a mid-size CRO with the largest Asia-Pacific presence, later renamed Caidya. Caidya is a global, multi-therapeutic CRO headquartered in Morrisville, North Carolina, emphasizing personalized partnership, international expertise, and knowledge sharing. Striving to impact the future of drug development and healthcare, Clinipace is committed to improving how clinical research is conducted in major therapeutic areas, including oncology, rare disease, gastroenterology, nephrology, and women’s health. Services include clinical development, clinical operations and delivery, regulatory services, and surveillance, and trial data and technology. In 2023, Caidya won the CRO Leadership Award for Overall Capabilities at the CRO Leadership Awards.  

Select the Right CRO for Your Clinical Trials  

Selecting the right Contract Research Organization (CRO) for your clinical trials is a critical decision that can significantly impact the success and efficiency of your research. It involves a thorough evaluation of the CRO’s expertise, experience, and capabilities in managing the specific therapeutic area of your study.  

Considerations should include the CRO’s track record in conducting similar trials, their understanding of regulatory requirements, and the quality of their data management and monitoring processes. Effective communication and collaboration are also key factors, as seamless interaction between your team and the CRO is essential for successful trial execution.  

Additionally, evaluating the CRO’s technological infrastructure and innovation capabilities can ensure that your clinical trials leverage the latest advancements in data collection and analysis. Ultimately, a well-informed selection process can lead to a successful partnership that accelerates the development of new therapies and enhances the overall efficiency of your clinical trials.  

Would you like more information on how TFS HealthScience can work with you to deliver your next clinical trial?  Contact us  today to start the conversation!  

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What is a CRO and how can it help you in your clinical trial

What is a cro.

In life sciences, a CRO is an outsourced company that acts on behalf of the sponsor and is in charge of the managing, monitoring and correct development of the clinical study.

A Contract Research Organization (CRO) acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.

It is a type of company that offers its clinical trial management services mainly to the pharmaceutical, biotechnology and medical device manufacturers.

The management of a clinical study is more complicated than it would seem, since many actors intervene (manufacturers, sponsors, ethical committees, Competent Authorities, Centers, Foundations, Researchers, legal departments, participants …). In addition, it is necessary to work under the rules of Good Clinical Practice and the Harmonization Guides (GCP-ICH Guidelines) that ensure the quality of the study. Being able to count on a CRO as a partner in which to trust the management of the study is essential. 

Services offered by a CRO

Traditionally, CROs have been in charge of initiating and monitoring clinical trials, but more and more we see companies offering all the services associated with conducting a clinical Study, such are considered “full service CROs”.

The services that a CRO can offer can be divided according to the phase in which we are in the study:

• The start-up includes the development and revision of protocols for trials, the adaptation of the necessary documentation to the applicable legislation, obtaining the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and preparation of the case report forms, the determination of the sample, the selection of the best researchers and research centers and the final negotiation of the contracts.
• Once approval is obtained and the trial begins, the CRO offers its services for monitoring, which consists of controlling compliance with the protocol and with the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in the event of the appearance of any Adverse Event.
• The last steps to ensure the success of any clinical study are the management of the data, the generation of reports and the control and storage of the documentation.
• Throughout the study, work is carried out in accordance with Good Clinical Practices (GCPs) that ensure the quality of the study.

Types of CROS

There are different criteria to classify CROs:

• If we take into account the level of specialization of the company, we can find companies specialized in a type of study (clinical trials, research with medical devices or observational studies) and also CROs specialized in a therapeutic area, such as oncology or ophthalmology.
• Taking into account the geographical area in which they move, we can classify CROs as local or global. Global companies tend to be large companies with headquarters all over the world, their coverage is greater, but they are usually less flexible than local companies, whose knowledge of the country’s peculiarities is greater, but their coverage is usually not as extensive.

How to choose a good CRO

Choosing a good CRO is very important, as much of the success of the study will depend on its management and will help the trial run as smoothly as possible.

Some of the questions to ask when choosing it are:

• If you are looking for a CRO that can also advise you on the choice of centers, the number of monitoring and even the necessary sample size. In this second case, it is essential to find an experienced CRO.
• If the way of working adapts to that of the sponsor
• If the rates you propose are adequate and provide a clear and disaggregated budget
• If it is a company committed to the study

CROs are a fundamental part of clinical trials that offer a wide variety of services associated with conducting the study that facilitate the work of the Sponsor.

There are many types of CROs, so it is essential that we know what to expect from them before starting to work together because they will be a key partner in the success of the study.

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Find out why we were the highest-rated ph i service provider for overall user preference and the highest-rated ph ii/iii cro for overall performance., discover why your cro search is over.

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At Worldwide, we believe a personalized approach is the only way to unlock the power of everyone working on a study – from operational and therapeutic experts to site partners and scientists. That means you’ll always have direct access to our experts. You’ll be able to tap into more than 30 years of therapeutic experience on a global scale. And your mission is our mission – we are dedicated to working with you to meet your goals.

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Your extended team…always within reach.

We were founded on an unwavering commitment to therapeutic excellence and personalized attention. And today, that’s more important than ever. That means you have access to our senior-level experts who will work directly with you. It means we listen to you, understand your study’s needs, and actively seek customized solutions that are tailored to your specific project – even if we need to pivot and adapt along the way.

Every study is different. Every path forward is different. And we will partner with you every step of the way.

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Flexible? Check. Responsive and nimble? Absolutely.

We understand that no clinical trial looks the same. Your trials deserve solutions backed by decades of therapeutically relevant and adaptable expertise. That’s exactly what we bring to the table.

When you partner with Worldwide, we’ll stay by your side through the entire lifecycle of product development with nimble, solutions that are never “just off the shelf” but customized for you and your specific needs.

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CRO Update: Where are Contract Research Organizations Headed?

How CROs have adapted to recent challenges—and how they’ll continue to evolve in the future.

Contract research organizations (CROs) have undergone significant changes in recent years, and even more changes are on the horizon. Some of the new and established trends in CROs are the result of technological advances, while others have arisen in response to market pressures or the COVID-19 pandemic. Experts say that spending on research and development has continued to grow over the last 15 years, even as the pandemic has caused biotech stocks to slump. However, CROs continue to face a variety of challenges, from competitive pressure to commoditization to evolving patient engagement models. Market stratification is placing pressure on smaller CROs to niche down or subcontract as larger organizations capture more of the market. As CROs navigate a post-pandemic future, there will be opportunities to implement lessons learned from COVID-19 and adopt emerging technologies that can improve data management, mitigate staffing shortages, or facilitate better patient monitoring and engagement.

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Anticipating Near-Term Structural Change in the Outsourcing Landscape

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The Anti-CRO for Ophthalmology Health Pioneers

Our All-in-One CRO solution delivers the full package of CRO services, site operations and technology necessary to operate your study. It starts with building your protocol through todelivering your data.

Accelerate your ophthalmology research. produce more human-centered clinical trials., fast-track the journey of bringing unique and innovative consumer health products to market with lindus health’s all-in-one consumer health cro., want to see everything included in our all-in-one offering.

We fast-track your ophthalmology research with our All-In-One Ophthalmology CRO solution that provides a full suite of end-to-end services for every phase of your trial.

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What is it like to work with Lindus?

"Lindus goes above and beyond to help tackle unexpected changes as they arise and provide exceptional services every step of the way.”

“In the past I’ve felt like most my interaction with CROs was about change orders; having a real partner with cost certainty is a game changer.”

“Working with Lindus has been a transformational experience. We would love to work with them again and again!”

"Lindus Health’s approach to clinical trial execution and their associated technologies should be incredibly helpful to biotech and pharmaceutical companies and enable them to bring new therapies to market faster and more efficiently."

“Working with the Lindus Health team has forever changed our experience running clinical trials. They have a can-do attitude and make things happen, going above and beyond the call of duty.”

“Lindus puts great emphasis on aligning incentives with sponsors, and their risk-sharing, milestone-based payment model is much needed in the CRO industry. Their patient and technology-centric approach to clinical trials will greatly benefit biotech and pharma companies, enabling faster, cost-effectve studies.”

“Lindus puts great emphasis on aligning incentives with sponsors, and their risk-sharing, milestone-based payment model is much needed in he CRO industry. Their patient and technology-centric approach to clinical trials will greatly benefit biotech and pharma companies, enabling faster, cost-effectve studies.”

Meet our dedicated Ophthalmology team

Dr. Luke Twelves

Vp of medical.

GP for 25 years, formerly CEO of Omnes Healthcare and director of clinical governance at United Health.

Olivia Dantonio

Trial nurse coordinator.

NMC registered and USA board-certified nurse with critical care experience in the UK and US. Passionate about supporting patients while making evidence-based treatment accessible to wider populations through clinical research.

Anthony Brogno

Director of clinical operations.

Over 15 years of experience in clinical research and patient advocacy. In the first half of his career, he led global clinical trials in various therapeutic areas for different CROs. In the past 7 years, he has worked with organisations of different sizes to develop new and innovative models for conducting clinical trials beyond traditional settings.

Shenna Cadiente

Trial coordinator.

Experienced clinical research nurse working across adult and paediatric trials managing and delivering Rare Disease research studies. Passionate in maximising the efficiency of research through public involvement and patient-centred approach.

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Frost & Sullivan Awards Avance Clinical for Global Biotech CRO Excellence, Highlighting Agility, Responsiveness, Customer Value, and Proven Ability to Expedite Quality Clinical Programs USA - English India - English

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Aug 26, 2024, 23:30 ET

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Avance Clinical streamlines its biotech clients' clinical trial operations, workflows, and data management, optimizing study efficiencies, minimizing costs, and accelerating trial timelines.

SAN ANTONIO , Aug. 26, 2024 /PRNewswire/ -- Frost & Sullivan recently assessed the biotech contract research organization (CRO) industry and, based on its results, recognizes Avance Clinical with the 2024 Global Customer Value Leadership Award. The company is a leading CRO facilitating top-tier clinical trials with globally recognized data for biotech firms worldwide. With an exclusive focus on the biotech sector, the company leverages over 30 years of deep clinical research experience across more than 250 therapeutic indications to provide customized services catering to biotech R&D's dynamic needs. Overall, the company's world-class team, exceeding 330 clinical and regulatory specialists, delivers high-quality clinical trials in Australia , New Zealand , Asia , Europe , and North America for international biotechs. As a full-service CRO, it builds on its extensive expertise across various modalities (ranging from small molecules to advanced cell therapies) to offer sophisticated solutions covering the entire spectrum of drug development, from preclinical stages through to Phase II/ III studies.

Avance Clinical comprehensively supports biotech clients through all clinical trial stages—including protocol development, site selection, patient recruitment, and data analysis—and eliminates the need to engage with multiple CROs. This streamlined approach optimizes clinical study efficiencies, minimizes overall costs, and accelerates trial timelines. Moreover, Avance Clinical, as a midsized entity, embeds itself deeply into its biotech customers' operations, with its scientific and regulatory consulting teams engaging as early as possible to optimize their trial designs and protocols. The company's flat organizational structure gives customers direct access to leadership teams, facilitating continual collaboration throughout their drug development journeys. Avance Clinical's in-house regulatory team seamlessly integrates into biotech clients' clinical and project delivery operations to minimize delays and costly errors by up to 50% and 30%, respectively.

Unmesh Lal , global research director at Frost & Sullivan, observed, "Unlike larger multinational CROs, this intimate approach enables Avance Clinical to understand customer challenges closely, empowering it to deliver flexible solutions and hands-on guidance that optimally position it to match the fast-paced nature of biotech R&D. As a result, the company's agility and responsiveness make it the ideal partner for small to mid-sized biotech companies, addressing a crucial need that competitors often struggle to fulfill."

Avance Clinical's in-house regulatory experts provide strategic counsel on study design, regulatory compliance, and protocol development, and they support customers' adaptability to rapidly evolving regulatory landscapes. The company assists biotech companies in achieving a 'clinic ready' status and offers a 'global ready' roadmap for later phases, effectively transitioning biotech products through the clinical development journey and towards marketing authorization. Its high-quality, globally accepted data empowers biotech clients to adequately address the sector's increasing drug development complexities.

Avance Clinical's expansive network of over 2,000 high-quality, trusted clinical trial sites ensures geographic diversity and a wide patient population for each client. It facilitates quick feasibility evaluations and rapid progression through start-up activities, allowing for expedited patient recruitment and shorter overall timelines. This ensures faster and more effective clinical trials, including accelerated study start-up durations of five to six weeks for early phase studies in Australia .

"Avance Clinical's customer focus, agility, and responsiveness position it as the ideal contract research organization partner for biotech customers. The company's globalization strategy, continual scientific collaboration, unmatched regulatory expertise, and personalization capabilities set it apart from its contemporaries. Its overall customer-first approach offers immense value to existing and new customers and solidifies Avance Clinical's reputation in the market," added Sama Suwal , best practices research analyst at Frost & Sullivan.

Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in implementing strategies that proactively create value for its customers with a focus on improving the return on the investment that customers make in its services or products. The award recognizes the company's unique focus on augmenting the value that its customers receive, beyond simply good customer service, leading to improved customer retention and customer base expansion.

Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

About Frost & Sullivan

For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, megatrends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact us: Start the discussion .

Tarini Singh P: +91 9953764546 E: [email protected]

About Avance Clinical Avance Clinical is the largest premium full-service Australian, Asian, and North American CRO delivering quality clinical trials with globally accepted data for international biotechs. The company's clients are biotechs completing Phase I to Phase III of their drug development program which requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase Avance Clinical offers pre-clinical consulting and regulatory services with their experienced ClinicReady team right from pre-clinical and Phase I through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 250 indications, the CRO can deliver world-class results and high-quality internationally accepted data for TGA, FDA and EMA review.

Technology Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

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Biotechnology

製薬会社の頼れる味方！CROってどんな存在？

CROの役割：治験を支える様々な業務

Croの重要性が高まっている背景, croの活躍が医療の発展を促進.

先生、「CRO」って医療関係の言葉で出てきたんですけど、どういう意味ですか？

「CRO」は「受託臨床試験機関」のことだよ。簡単に言うと、薬を作る会社から、新しい薬の効果や安全性を確かめる試験を頼まれる会社のことなんだ。

なるほど。薬を作る会社は自分で試験をしないんですか？

薬の試験は専門的な知識や経験が必要だから、専門の会社に頼むことが多いんだよ。CROは試験を計画したり、試験がちゃんと行われているかチェックしたりする役割を担っているんだ。

「医薬品の開発支援機関」を指す『CRO』について説明します。 CROは、製薬会社からの依頼を受けて、新薬開発のために行われる臨床試験を代行する企業のことを指します。製薬会社から臨床試験を任されたCROは、試験を行う医療機関に担当者を派遣し、試験が計画通りに実施されているかを確認する、モニタリング業務を行います。 モニタリング業務に加えて、CROは質の高い臨床試験を実施するために、試験計画書を作成したり、集めたデータの管理や分析なども行います。

– CROとは

CROとは、Contract Research Organizationの略で、日本語では「受託臨床試験機関」と言います。 新しい薬を開発する際には、その薬の効果と安全性を確かめるための臨床試験が欠かせません。しかし、製薬会社にとって、これらの試験全てを自社で行うことは容易ではありません。 なぜなら、臨床試験は非常に複雑で、多くの時間と費用、専門知識を必要とするからです。

そこで、製薬会社は試験の一部、あるいは全体を専門機関に委託することがあります。 この専門機関こそがCROです。 CROは、製薬会社に代わって、臨床試験に関わる幅広い業務を請け負います。具体的には、臨床試験の計画の作成から実施、被験者から得られたデータの収集、解析、そして結果をまとめた報告書の作成までを行います。

CROに業務を委託することで、製薬会社は時間と費用を抑え、自社の資源をより効率的に新薬の開発に充てることができるようになります。 また、CROは臨床試験に関する豊富な経験と専門知識を持つため、質の高い臨床試験の実施と、より正確で信頼性の高いデータの取得が可能になります。

– CROの役割治験を支える様々な業務

新しい薬が患者さんのもとに届くまでには、多くの時間と費用をかけた、厳密なプロセスを経る必要があります。その中でも特に重要なのが「治験」 です。治験とは、開発中の薬の効果や安全性を確認するための臨床試験のことですが、その実施には膨大な作業と専門知識が求められます。そこで、近年注目されているのがCRO(医薬品開発受託機関)です。

CROは、製薬会社から治験の一部、もしくは全ての業務を請け負い、治験がスムーズかつ適切に実施されるよう、様々な業務を遂行します。具体的には、まず治験の計画段階において、 治験実施計画書(プロトコル)の作成 を行います。この計画書には、治験の目的、方法、期間、対象となる患者さんの基準などが事細かに記載されます。

治験の実施段階に入ると、CROは 治験に参加してくださる患者さん(被験者)の選定 、治験を実施する医療機関への 臨床開発モニター(CRA)の派遣 を行います。CRAは、治験が計画書通りに実施されているか、患者さんの安全は守られているかなどを監視する、非常に重要な役割を担います。

そして、治験期間中は、患者さんから得られたデータの収集、管理、解析などもCROの重要な業務です。これらのデータは、最終的に新薬の承認申請に必要な報告書としてまとめられます。

このように、CROは治験の計画から実施、データ解析、報告書作成まで、幅広い業務を担うことで、治験の 品質、安全性、倫理性 を確保し、ひいては新薬開発の成功を支えているのです。

– CRAとCROの違い

臨床試験を取り巻く用語として、CRAとCROという言葉がよく聞かれます。どちらも臨床試験に深く関わる役割を担いますが、その違いについて詳しく見ていきましょう。

CROは、「医薬品開発受託機関」を意味する Contract Research Organization の略称です。製薬会社が新しい薬を開発する際、様々な試験や手続きが必要となりますが、CROはこれらの業務を製薬会社から受託して代行します。つまりCROは、 製薬会社のパートナーとして、医薬品開発を効率的かつスムーズに進めるための専門的なサービスを提供する企業 と言えます。

一方、CRAは「臨床開発モニター」を意味する Clinical Research Associate の略称です。CRAは、CROに所属する従業員であり、 実際に医療機関に出向いて、治験が計画書通りに実施されているか、患者さんの安全は守られているかなどを確認する重要な役割 を担います。具体的には、症例報告書の確認、治験薬の保管状況の確認、医療従事者への説明や指導などを行います。CRAのきめ細やかな monitoring業務によって、治験の品質と患者さんの安全が確保されます。

つまり、CROとCRAは密接な関係にあり、CROはサービスを提供する企業、CRAはそのサービスを現場で実行する担当者ということができます。両者の連携によって、より安全で効果的な医薬品が開発され、患者さんに届けられるのです。

– CROの重要性が高まっている背景

現代の医療において、新しい薬を開発することは、以前よりもはるかに難しく、複雑になってきています。 それに伴い、新しい薬が本当に効果的で安全かどうかを確認するための臨床試験も、大規模で複雑なものとなっています。

製薬会社は、これまで自社の研究施設や病院と協力して、これらの臨床試験を行ってきました。しかし、近年の臨床試験の規模拡大や複雑化に伴い、製薬会社だけで全てをこなすことが難しくなってきています。そこで、臨床試験を専門に行うCROと呼ばれる企業に、試験業務を委託するケースが増加しています。

また、近年は新興国が経済成長を遂げ、世界的に医療への需要が高まっています。 新しい薬の効果や安全性を世界中の人々で確認するためには、世界規模で臨床試験を実施する必要があり、これもCROの需要が高まっている要因の一つです。CROは世界中にネットワークと豊富な経験を持つため、グローバルな臨床試験にも柔軟に対応できるという強みを持っています。

近年、医薬品開発の分野において、CRO(医薬品開発受託機関)という存在が注目されています。CROは、製薬会社に代わって医薬品の臨床試験や承認申請などの業務を請け負う企業です。

CROは、 製薬会社のパートナーとして、新薬開発のスピードアップとコスト削減に大きく貢献しています。 具体的には、製薬会社から依頼を受け、臨床試験の実施計画の立案から、試験の実施、データ収集、解析、そして承認申請に必要な書類作成まで、幅広い業務を担います。

CROの活躍は、 製薬会社が新薬開発に専念できる環境を整え、結果として、より革新的な医薬品を患者さんに届けることに繋がります。 近年、医療技術は日々進歩しており、それに伴い、新薬開発のプロセスも複雑化しています。CROは、高い専門性と豊富な経験を持つ人材を擁し、複雑化する新薬開発を効率的に推進することで、医療の発展に貢献しています。

製薬会社とCROのパートナーシップは、今後ますます重要性を増していくと考えられています。新しい治療法を待ち望む多くの患者さんのために、CROは陰ながら医療の発展を支え続ける存在です。