CSIA Services
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.
Services
- 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.
- Archiving for individual clinical trial (GCP documents)
- Reconciliation of case report forms
- 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)
- Quality check for CSR
- Submission of audit report and records
- Issues of the audit certification