The following services are provided:

Audits

  • Internal audits on behalf of the client
  • "Mock-audit", to prepare for an upcoming inspection or sponsor audit
  • Preparing for Headquarter audits by reviewing and assuring completeness of study files

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

Training

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