Contract Research Organization (CRO) is a specialized entity that conducts clinical trials and research on behalf of pharmaceutical, biotechnology, and medical device companies. CROs assist sponsors in the development and evaluation of medical products providing a range of services, including:
- study design,
- patient recruitment,
- data collection and analysis,
- regulatory compliance,
- quality assurance, etc.
Definitions
ICH E6(R2)
ICH E6 1.20 Contract Research Organization (CRO):
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].
See also
Links to this page
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf