A contract research organization, or CRO for short, is a specialized provider that is outsourced on a contractual basis by pharmaceutical, biotechnology, and medical device companies (sponsor) in the clinical research industry to manage various aspects of clinical trials. Typically, sponsors can transfer one or more of their own trial-related duties and functions to a CRO throughout the lifecycle of clinical trials, wherein the transferred duties are specified in writing. 

For sponsors looking to conduct clinical trials efficiently and effectively, understanding the functions and responsibilities of a CRO is paramount. In this article, we will explore the key aspects of what a CRO actually does and why their expertise is vital for successful clinical trial management. 

The Global Demand for Contract Research Organizations (CROs) 

Estimates by Global Market Insights valued the CRO market size at US$56.7 billion in 2022 and projected a compound annual growth rate (CAGR) of 6.9% between 2023 and 2032 to US$108 billion in 2032. Although the COVID-19 lockdown restrictions in 2020 initially slowed the market, it quickly rose again as R&D and manufacturing processes resumed and CRO partnerships in clinical research were being embraced by biopharma and biotech sponsors worldwide. The COVID-19 pandemic also accelerated the transition from traditional paper-based records to digital data solutions, creating a niche in which the advanced technologies typically offered by CROs could especially flourish. Overall, the projected market growth of this industry is driven primarily by increasing R&D expenditure worldwide, greater number of clinical trials emerging in different countries, and increasing capabilities of globalized clinical research as a result of rising technological advancements. 

The Role of the Contract Research Organization 

Nearly three out of every four clinical trials are estimated to be conducted by a CRO contracted by sponsors, underscoring the value of these companies to the drug development process today. Although they may have started out as a peripheral vendor to which clinical trial companies could outsource certain R&D activities, CROs are now considered an integral partner within the pharmaceutical, biotech, and medical device industries. The primary advantage of such a partnership is the flexibility and resources CROs provide to sponsors,  freeing up their time to invest more in R&D innovation and allowing them to thrive in a competitive fast-paced marketplace. 

Clinical Trials Services Provided by Contract Research Organizations 

There is a significant variety in the types of services that a CRO can offer for sponsors, comprehensively covering multiple areas spanning the drug development pipeline, from initial discovery of a new molecule to post-marketing surveillance. Visit our article on the TFS Intellect Hub to discover the top 10 must-have services offered by leading CROs. 

• Pre-clinical research: Providing facilities to support initial testing and analysis of a new drug or medical device. 
• Clinical research: Providing trained teams of clinical trial professionals to oversee the administration and management of clinical trials, as well as navigate local regulatory guidelines to maintain strict compliance. 
• Other services: Providing specialty services in bioanalysis, data management, biostatistics, central laboratory capabilities, and many more. 

In terms of the services they provide, CROs are typically classified as either full-service, specialty, or some combination thereof. Whereas a full-service CRO can support clinical trials through a comprehensive array of services (e.g., project management, site selection, data management, etc.), specialty CROs offer a focused scope of services that is limited to a specific area (e.g., oncology, preclinical development, medical devices, etc.). For example, TFS HealthScience is a full-service CRO with teams supporting numerous topics of expertise (see here) and solutions (see here).  

Regardless of the type of CRO chosen, the vast diversity of duties they can perform for clinical research companies creates a strong support system that enables sponsors to streamline their operations and focus their resources on innovation and growth.  

How Contract Research Organization Partnerships Impact Clinical Research 

According to a 2023 report released by PPD, The Pulse: Global R&D Insights in Pharmaceuticals, many of the respondents noted a growing strain of talent shortages, of which 41% increased their reliance on CROs through functional service provider partnerships. By leveraging the specialization and expertise of a CRO, biopharma and biotech companies can accelerate their drug discovery and development processes, thereby bringing vital new treatments to market more quickly. Furthermore, as clinical trials become increasingly globalized, CROs act as an invaluable partner enabling sponsors to navigate numerous local regulatory restrictions and overcome such challenges to ensure their clinical research activities are fully compliant.  

Conclusion 

CROs play a pivotal role in the pharmaceutical, biotech, and medical device clinical research industries as a result of the broad and diverse array of services they provide in the pursuit of bringing new therapies to market. By outsourcing their research and development activities to a CRO, companies can maintain a focus on their core competencies, while also benefiting from the specialized expertise and substantial infrastructure of the CRO. As the landscape of these industries continues to evolve and grow, the role of CROs within this ecosystem is likely to become even more critical and indispensable in the future, evidenced by the expected growth of the CRO market over the next decade alone.  

About TFS HealthScience CRO 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients. 

Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!