chapter  5
14 Pages

Working with a Contract Research Organization (CRO)

ByDuane B. Lakings

INTRODUCTION The use of contract research organization (CROs) or contract service organizations (CSOs) in discovery, nonclinical, clinical, and manufacturing drug development programs-or “outsourcing,” as the process is commonly referred to by the industry-is a common practice of most, if not all, pharmaceutical and biotechnology companies. At present, more than 450 CROs exist in the United States and Europe with others being started or already available in Asia, and the use of their services for all aspects of the drug discovery and development process is rising. The growth of outsourcing is expected to continue, with some CROs offering an almost, but not quite, complete drug development support system, from synthesis and characterization of the drug substance to conducting phase 3 safety and efficacy human clinical trials, and preparing marketing applications, such as an New Drug Application (NDA), documents for submission to regulatory agencies. Other CROs specialize in selected aspects of the drug characterization process, offering services in such areas as pharmacology animal model development and implementation, formulation development and drug substance and proposed drug product stability testing, bioanalytical chemistry method development and validation, or clinical trial protocol preparation and study support, such as site and investigator selection or data management.