How to Select and Oversee Contract Research Organizations

Pharmaceutical and biotechnology companies face the challenge of managing the operation and costs associated with bringing a drug to market. The return on investment (ROI) must be greater than the huge amounts of money spent during years of research and development. The right choice for clinical trial outsourcing can facilitate trial execution and reduce the timeline to completion, thus reducing costs and increasing ROI. Central and Eastern European and emerging markets are increasingly being incorporated in clinical trials from planning to trial execution. Outsourcing and vendor selection choices have broadened to include emerging markets, which have demonstrated clinical trial success by tapping patient populations, increasing enrollment rates, and achieving early completion. Vendors in these markets have gained valuable experience which can be leveraged in future trials. This chapter examines the alternatives and variables to consider when selecting and overseeing a contract research organization to support a global clinical trial.