The following services are provided:


  • Full service CRO audits
  • Vendor audits (e.g. Pharmacovigilance, Data Management, Laboratory)
  • Computerized system audits (e.g. Data Management Systems, Safety Database, Trial Master File)
  • "Mock-audit", to prepare for an upcoming inspection or sponsor audit

Quality Management System

  • Develop / implement Quality Management System
  • Define the actual company/study processes
  • Quality Control of company SOPs
  • Develop the required SOPs
  • Provide support as an Interim Quality Assurance Manager

Monitor procedures

  • Implement Monitor procedures for clinical trials
  • Provide monitor training


  • Good Clinical Practice (ICH GCP)
  • Inspection readiness
  • Company specific SOPs
  • Training and coaching monitors / CRAs
  • Training and coaching Clinical Trial Assistants