Clinrex provides consulting services across all areas of GCP and clinical quality management. Examples include:

• Review of your company’s GCP Quality Management System (QMS), with a particular focus on SOPs
  
  • GCP and regulatory compliance
  • Gap analysis
  • Opportunities for streamlining and process improvement
• Development and review of SOPs
• Implementation of risk-based Quality Management within your organization
• Planning and conduct of clinical trials
• Inspection and audit preparedness 
• Sponsor - CRO relationships and oversight
  • CRO selection
  • Contractual aspects
  • Management of challanging situations, e.g. a change of CRO 
  • CRO oversight
• Investigator Initiated Trials (IITs)
• Non-interventional studies (NIS)