Sites & Operations
Contract Research Organization (CRO)
A Contract Research Organization (CRO) is a service organization that contracts with a pharmaceutical, biotech, or medical-device sponsor to perform some or all of the operational activities of a clinical trial, from protocol design through regulatory submission.
Major full-service CROs (IQVIA, Labcorp Drug Development, Parexel, Syneos, ICON, PPD, Fortrea, Medpace) provide clinical operations, data management, biostatistics, regulatory, medical writing, and pharmacovigilance. Functional Service Provider (FSP) models contract specific functions rather than a full study.
Sponsor-CRO oversight obligations under ICH E6(R3) require documented vendor governance, quality oversight, and transfer-of-obligations records.
Related terms
Sponsor (Clinical Trial)
A sponsor is the individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial, including regulatory submissions, IP supply, monitoring, safety reporting, and reporting of results.
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
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