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Quality Assurance

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 upon the request from our customers for all studies by building-up the scope of audit adequately covers the sponsor’s demands such as 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

Audit Work Flow

Audit of In–house Systems
  • Organizing and system for clinical trial
    Service contract, allocation of staff, etc.
Audit of In–house Documents
  • Archiving for individual clinical trial (GCP documents)
  • Reconciliation of case report forms
On–site Audit
  • Organization and system for GCP
    Review of SOPs, clinical trial office / secretariat, system in case of emergency, etc., facilities tour for storage of investigational products / documents
  • Documentation and records for trial
  • Cross confirmation between case report forms and source documents (medical records, records of lab test)
Audit of Clinical Study Report
  • Quality check for CSR
Audit Report Submission
  • Submission of audit report and records
  • Issues of the audit certification