Contract Research Organization (CRO) | Practical Law

Contract Research Organization (CRO) | Practical Law

Contract Research Organization (CRO)

Contract Research Organization (CRO)

Practical Law Glossary Item w-001-3983 (Approx. 2 pages)

Glossary

Contract Research Organization (CRO)

A person, company, or other organization that contractually assumes one or more of a clinical trial sponsor's obligations. The Food and Drug Administration (FDA) defines and regulates contract research organizations (CROs) (21 C.F.R. § 312.3), and may hold a CRO directly responsible for any sponsor obligations it assumes under an investigational new drug application.
CROs can provide broad services or particularized expertise to sponsors that may not be available within the sponsor's organization. The services that CROs provide include:
  • Preclinical research activities.
  • Clinical research monitoring.
  • Protocol design.
  • Clinical trial management.
  • Preparation and submission of regulatory materials to the FDA or other regulatory agencies.
  • Completing post approval regulatory obligations and reports.