A contract research organization (CRO) is a specialized clinical research provider engaged on a contractual basis to manage various aspects of clinical trials. CROs can be traced back to the 1930s. They have evolved to be of various sizes, have different areas of expertise and geographical focus, and provide a range of services matching the needs of sponsors. Drug development requires extensive research, with drug discovery (approx. five to six years) and clinical trials (five to seven years) conducted in compliance with stringent regulatory requirements. In-house research may not be viable for some sponsors, and the advantages of outsourcing to CROs make it a clear choice. In this article, we describe what a CRO is and the role of CROs in drug development.

CRO Defined

CROs are specialized clinical research providers (also known as contract research providers) that partner with pharmaceutical, biotech, and medical device companies (sponsors) to manage clinical trials. Typically, sponsors transfer one or more of their trial-related duties and functions to a CRO throughout the lifecycle of clinical trials. CROs are essential in ensuring clinical trials are run efficiently, ethically, and in compliance with ethical and regulatory requirements.

Types of CROs include full-service CROs, which support trials through a comprehensive offering of services; specialty CROs, with a range of services limited to a specific area (e.g., oncology or preclinical research); or a combination of the two. According to IBISWorld, there were 5,096 CROs in the U.S. as of 2023, an increase of 7.5% from 2022. To address the changing clinical research landscape, CROs have expanded their services to include innovations, e.g., decentralized clinical trials (DCTs), artificial intelligence (AI), and enhanced patient recruitment.

The Challenge for Sponsors

Drug development is costly, and it takes, on average, 10 – 12 years to successfully bring a new drug to market. Only ten out of 10,000 candidate drugs originally screened enter clinical trials, while only one out of ten drug candidates in clinical trials is eventually approved for patient use (according to a Deloitte study).

Partnering with CROs

To accelerate drug development, sponsors outsource to CROs who provide specialized services and expertise. Understanding sponsors’ challenges and aligning CRO services to meet their needs throughout the drug development lifecycle allows CROs to continuously bring value to sponsors in a rapidly changing industry. Sponsors sometimes prefer a comprehensive approach encompassing advanced technologies, streamlined processes, and regulatory expertise. To learn what sponsors value most in CRO relationships, TFS HealthScience surveyed in 2023 and found that the quality of sites and patients, CRO experience and capabilities, and connection in a CRO relationship are most valued. 

In recent years, the number of new clinical trials exceeds the number of available clinical research sites to conduct the trials. At the same time, clinical trials have also increased in complexity, further adding to site-level burden. In addition to speed-to-market, cost-effectiveness, and regulatory expertise, sponsors are increasingly demanding from CROs an investment in advanced technologies, integrated solutions, enhanced flexibility and scalability, data analytics, digital transformation, cybersecurity awareness, real-world evidence (RWE) generation, personalized medicine, DCTs, adaptive clinical trial design, and patient-centric strategies.

TFS HealthScience explored the CRO industry’s 2024 roadmap and observed the shifting of focus from tech-driven speed to patient-powered progress, democratizing data, harnessing tech for empathy, and prioritizing mental well-being alongside physical health.

A CRO’s Role in Drug Development

CROs are essential in ensuring clinical trials are run efficiently, ethically, and in compliance with ethical and regulatory requirements. CROs contribute to every step of the drug development process, from discovery and development to post-market safety monitoring. Functions of the CRO include pre-clinical research, clinical trial planning and management, data management, and post-marketing surveillance. In a fast-changing environment, below are some CRO roles and services that bring value to sponsors throughout their drug development journey (Diagram 1).

According to a McKinsey study, the top ten services offered by leading CROs include project management, clinical trial management, data management services, regulatory affairs expertise, and medical writing. In addition, top CRO services include biostatistics support, quality assurance services, PV support, and lab services. Other CRO services may include bioanalytical and central lab services, clinical monitoring, supply delivery logistics, medical monitoring, site selection, study design, site and patient payments, patient selection and recruitment, and specialty lab services.

Diagram 1. CRO Services throughout the Drug Development Process.

Step 1: Discovery and Development Research for new drugs begins in the lab	Step 2: Preclinical Research Drugs undergo lab & animal testing	Step 3: Clinical Research Drugs are tested on people to ensure they are safe & effective (Phase I, II, III)	Step 4: Regulatory Review Regulatory review teams thoroughly examine all submitted data to make an approval decision	Step 5: Post-Market Safety Monitoring The regulatory agency monitors all drug & device safety once available for use by the public
CRO Services Project Management,  Data Management & Biostatistics, Medical Writing, Strategic Resourcing Solutions
Laboratory Capabilities  Regulatory & Start-up  Clinical Strategy & Submissions  Product Maintenance  Marketing Authorization  Study Start-up Planning  Feasibility & Site Selection  Patient & Site Recruitment		Drug Safety & Pharmacovigilance services,  Quality & Compliance,  Medical Monitoring, Study Maintenance & Completion
		Clinical Monitoring  On-site monitoring  Remote monitoring  Centralized monitoring  Online project tracking  Risk-based monitoring	Submission & clinical study agreements (CSAs) Agency & Ethics queries	RWE (non-interventional studies/Phase IV)  Real-World Data (RWD) sources  Analytics  e-Digital  Life Science

CRO Services

1. Regulatory and study start-up services 

As part of the regulatory and study start-up services, CROs will work on clinical strategy and submissions, which include regulatory strategy and support, clinical trial document review, preparation and development support, and Orphan Drug Applications. Product maintenance includes updates of the summaries of product characteristics (SPCs)/product leaflets/labeling. In addition, market authorization consists of preparing and submitting marketing applications, compiling and submitting all procedures, and labeling proposals. Good site selection and initiation are paramount for successful clinical trials and include planning, followed by feasibility and site selection, submission, and clinical study agreements (CSAs), agency and ethics queries, study maintenance, and completion.

2. Clinical monitoring 

Clinical monitoring solutions tailored for each protocol help keep clinical trials on track and mitigate risk. Strategic monitoring plans include on-site monitoring conducted by the clinical research associate (CRA) at sites. In contrast, remote monitoring includes remote monitoring visits, off-site data review, teleconferences, and electronic document collection. Additionally, centralized monitoring, e.g., remote evaluation of accumulating data across the study, online project tracking such as a customer portal for sponsors to track project deliverables, and risk-based monitoring, which is a dynamic approach to the design, implementation, and oversight of the trial, are provided by CROs.

3. Project management 

Project managers, driven by quality and operational excellence, manage day-to-day activities. 

4. Data management and biostatistics 

CROs provide data management and biostatistics solutions for generating accurate data, e.g., tools to capture, analyze, and display data.

5. Medical writing 

Medical writing and the quality of documentation, including regulatory writing, provided by CROs.

6. Strategic resourcing solutions 

For companies requiring resourcing solutions, CROs like TFS HealthScience provide strategic resourcing solutions, such as professional insourcing and recruitment services for individuals or entire teams. Services also include operationalizing talent and ongoing governance.

7. Drug safety and pharmacovigilance (PV) 

Drug safety and PV experts establish, manage, and optimize sponsors’ product safety needs throughout the entire clinical development and post-marketing journey.

8. Quality and compliance 

CROs must ensure data integrity and high-quality services for all customers, including addressing global compliance challenges.

9. Medical monitoring 

Medical monitors are physicians who provide strategic guidance and resolve detailed issues, among other things. Their services include protocol design and review, medical data review, interaction between the site and site management team, study report review, and medical safety monitoring.

 

Selecting your CRO Partner 

Here are five steps to take to find your right CRO partner. Before that, if you are searching for a trusted CRO partner to support your research journey, TFS is here to help. We combine a large CRO’s full-service capabilities and global reach with the flexibility and personal approach only a mid-size CRO can deliver.  

TFS HealthScience is a full-service CRO with teams supporting numerous topics of expertise (see here) and solutions (see here).

Would you like to learn more about how TFS can help you deliver your next clinical trial?  Contact us today to start the conversation!