Clinical Research Organization


Client: Clinical Research Organization
Service: System Audit
Place : Delhi CRO, India


  • Company’s Management Philosophies towards Quality and Compliance
  • Company’s track record in Quality and Compliance
  • Company’s Peers in the Industry view
  • Employee or Process Errors have occurred since the last few significant change-control
  • How Rejections handled
  • Regulatory Action against the company


  • Analysis of CRO Team (Has Company Lose
  • Process Analysis
  • Implementation of CAPA
  • Follow up with industry standards and Guidlines