ABSTRACT
The International Conference on Harmonization (ICH) document “E6 Good Clinical Practice: Consolidated Guidance” defines a Contract Research Organization (CRO) concisely as, “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” CROs can perform many, if not all, of the tasks associated with the development of a drug, including developing drug compounds, conducting toxicology studies, carrying out Phase I to Phase IV clinical trials, producing a submission, and many more. Larger CROs may have the resources to provide any of these services, but more typically, a CRO will specialize in a few particular areas. Data management groups will have the most contact with CROs conducting clinical trials rather than those involved with drug development, for example.
