ABSTRACT
The use of CROs 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 many pharmaceutical and most biotechnology companies. At present, more than 450 CROs exist in the United States and Europe 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 a complete drug development support system, from synthesis and characterization of the drug substance to conducting phase 3 safety and efficacy human trials and preparing 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 drug product stability testing, bioanalytical method development and validation, or clinical trial protocol preparation and study support, such as site and investigator selection or data management.
