ROTFEL

PHARMACEUTICAL LIBRARY

CRO

Contract Research Organization (CRO)

A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.

The International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) in its Good Clinical Practice (GCP) guidelines defines a CRO 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.” (1.20).

Furthermore

  • (5.2.1) A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
  • (5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
  • (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
  • (5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

ROTFEL © 2014 Frontier Theme