Clinical and Quality Systems support

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