Auditing Services

Sponsor Audits and Services

  • Clinical Database and Data Management Audits
  • Clinical Protocols and Clinical Study Reports (CSR)
  • Clinical Trial Audits
  • Investigator Brochures (IB)
  • Regulatory Submission Document Review and Audits
  • Trial Master Files (TMF) Audits
  • PAI Readiness
  • Gap Analysis
  • Internal Audits

Vendor/Contract Service Provider Audits

  • Part 11 Compliance: IVRS, IWRS, EDC, eDiary, CTMS, EDMS
  • Bioanalytical & Toxicology Laboratories (GLP)
  • Central Laboratories (GCP)
  • Contract Research Organizations (CROs)
  • eSystem Service Providers: Datacenters, ECG Core Laboratory, eDiary
  • In-Vitro Diagnostic and Medical Device Sites
  • IRBs/IECs
  • Kit Manufacturing and Clinical Trial Supplies Logistics
  • Manufacturing, Storage, and Distribution Sites
  • Non-clinical (animal) Studies
  • Pharmacovigilance and Complaint Handling Sites
  • Phase I-IV Investigator Sites
  • For-Cause Audits