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)