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GCP audit

Conduct timely audit and quick submission of audit report

Ensure the quality improvement and the reliability of the commissioned services by implementing internal GCP audits for all studies.

Main Services

Building-up the scope of audit adequately covers the sponsor’s demands.
Timely issues audit plan, audit report, checklist and audit certificate in line with the service agreement.

  • Audit for clinical trial (medicinal product, medical device/sponsor or investigator initiated trial)
  • Audit for GCP System
  • Audit for investigator-initiated clinical study
  • Capability assessments (Client, In-Country Clinical Caretakers, CROs, etc.)
  • Mock inspection
  • SOP review

Flow of Audit

Flow of Audit