The Role of Contract Research Organizations in Drug Development & Clinical Trials

Contract research organizations, or CROs, are playing an increasingly important role in drug development and clinical trial management. According to Thomson CenterWatch, CROs played a substantial role in 64% of phase 1, 2 and 3 clinical studies in 2003, as compared with 28% in 1993.¹

Why has the role of contract research organizations grown so dramatically in just ten years? For many of the same reasons other industries have turned to outsourcing: cost savings, access to expertise, and shorter product development cycles.

According to one study,² each day a drug is delayed in going to market costs the sponsor $1 million in lost revenue. Drug development costs have skyrocketed, and clinical trials have become longer and more complex due to factors including tighter FDA regulation and increasing data requirements. Therefore, it’s critical for sponsors to meticulously design trials to gain approval or "fail early" in preclinical or phase 1 if the compound is likely to ultimately fail to gain such approval.

Good contract research organizations have management and medical teams with many years of expertise in developing NDAs, making them logical partners to help sponsors develop studies that stand the greatest probability for approval. Many CROs offer a full suite of drug development and clinical trial management services, and choosing a CRO with deep therapeutic expertise to support your entire drug development process can be the best hedge against rising costs and lengthy trials.

Common services offered by contract research organizations

Preclinical program analysis, design, management and execution
Preclinical program review and "gap analysis"
Trial strategy and design to gain FDA approval
Site identification, qualification, management, contracting and payment
Investigator identification & recruitment
Patient recruitment & accrual strategies
Project management
Clinical monitoring
Medical monitoring
Data management
Pharmacovigilance
Statistics
Medical writing
EDC
Regulatory compliance
Quality assurance

» Next: Working with a contract research organization

1. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics. Boston: Thomson CenterWatch, 2007. Citation via Commericalizing Clinical Trials – Risks and Benefits of the CRM Boom by Miriam Schuchman, M.D. The New England Journal of Medicine, October 4, 2007.

2. Pharmaceutical Outsourcing: Contract Research Organizations. UBS Warburg LLC, 2003.