GCP Audits

Good Clinical Practices (GCPs) are critical to both ensure patient safety and integrity of data generated during clinical trials.  Regulatory bodies require that clinical trials be conducted following GCPs.  Globiox auditors have extensive experience auditing sponsors, investigators, and other support sites against ICH E6 R2, FDA regulations 21CFR parts 11, 50, 54, and 56, and others.

Globiox's team of expert Good Clinical Practice (GCP) Auditors ensure your company has conformed to ever changing regulations. Below is an abbreviated list of some GCP audits we perform. If you require a specialty audit, or an audit type not listed below, contact our team of experts for a free evaluation of your needs.  

  • Domestic and International Clinical Research Trial Audits
  • Contract Research Organization (CRO) Audits
  • Centeral & Specialty Laboratory Audits
  • Clinical Trial Supply & Drug Depot Audits
  • Institutional Review Board Audits
  • Audits of Final Study Reports
  • Adverse Event Reporting System and Pharmacovigilance Audits
  • Computer Systems Validation Audits
  • FDA Mock Audits including: Biostatistics, Clinical Operations, Clinical Trail Supplies/Suppliers, Drug Safety, Regulatory Affairs, Quality Control, Quality Assurance, Medical Writing, and more
  • IND/IDE Safety Reports
  • System and Process Audits
  • Supplier Audits
  • Data Integrity Audits
  • REMS Audits
  • Contract Manufacturer Organization (CMO) Audits