Clinrex provides consulting services in all areas of GCP / quality management. Examples are:

  • Review of a company’s quality system, in particular review of SOPs
    • GCP and regulatory compliance
    • Gap analysis
    • Streamlining possibilities
  • Writing of SOPs
  • Implementing risk-based Quality Management in your company
  • Planning and conduct of a clinical trial
  • Inspection preparedness / audits and mock inspections.
  • Sponsor - CRO relationship
    • CRO selection
    • Contractual issues
    • How to handle difficult situations, e.g. CRO switch
    • CRO oversight
  • Investigator Initiated Trials (IITs)
  • Non-interventional studies (NIS)