GCP (Good Clinical Practice) audits are required for companies conducting clinical trials on investigational medicinal products or medical devices that involve the participation of human subjects. Sponsor companies must meet the international ethical and scientific standards of GCPs and are responsible for ensuring that the design, study conduct, performance, monitoring, auditing, analysis and reporting of their clinical studies meet GCP requirements and that the data and  results submitted to regulatory agencies are legitimate. GCP audits can be conducted in conjunction with site monitoring visits. Our global team of GCP auditors help you maintain compliance with 21 CFR Parts 11, 50, 54, 56, and ICH E6(R2) regulations by conducting audits of:

  • Contract Research Organizations (CROs)
  • Investigator/Clinical Sites 
    • Routine
    • For-cause/suspected fraud
    • Site qualification audits
    • Interim site audits
    • Study completion audits
    • Investigator financial disclosure
  • Central and bioanalytical labs
  • Data Management (IRT)
  • Trial Master File (TMF/eTMF)
  • BIMO (Mock Bioresearch Monitoring)
  • REMS (Risk Evaluation and Mitigation Strategies)
  • PV (Pharmacovigilance)
  • Institutional Review Board (IRB) 
  • GCP Inspection Readiness
  • Phase 1 Units

In addition to audits and consulting, we can provide customized on-site training. Click here to learn more.