A Contract Research Organization (CRO) is an external provider that delivers outsourced services to sponsors for planning, running, and managing clinical trials.
CRO services may include study startup, site monitoring, data management, pharmacovigilance, regulatory submissions, and project management across development phases. Sponsors use CROs to scale operations quickly and access specialized expertise for global or complex trials. CRO performance directly affects protocol compliance, participant safety, and data integrity. Strong sponsor oversight of CRO activities is essential for regulatory readiness and quality assurance.