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Clinical Trial office Support

It is the supporting service for investigational site to operate the study smoothly; especially supporting for organizing clinical trail system, and preparing and managing documentation created during the study.

  • Organizing clinical trial system (GCP system)
  • Organizing standard operating procedure (documentation and amendment)
  • Inspection support of investigator and investigational site for site selection
  • Operation support of clinical trial 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
  • Training of clinical trial staff
  • Other clinical trial office related support tasks