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IRB Office Support

It is the supporting service for institutional review board established by investigational site for smooth study operation; especially, preparing the documentation and operating IRB.

  • Organizing clinical trial system (GCP system)
  • Organizing standard operating procedure (documentation and amendment)
  • Establishment support of IRB office
  • Operation support of IRB office
  • Organizing clinical trial contract
  • Preparing, archiving, and managing all the documentation
  • Supporting the contact with sponsor
  • Supporting the correspondence with monitoring and audit from sponsor and regulatory authorities
  • Other clinical trial office related support tasks