Contract Research Organization (CRO) Audits

Conducted on behalf of the sponsor, the audits help ensure that the CRO is in compliance with Good Clinical Practice (GCP) regulations and will include:

• Verifying adherence to program specific procedures outlined in the clinical research protocol(s) and contractual agreements.
• Verifying data supporting the clinical trials are generated, recorded and reported in compliance with the protocol and SOPs.
• Training review
• 21 CFR Part 11 assessments