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3rd PARTY QA AUDIT

Independent third party inspection is provided for the following items:


1. Phase BE, PK and I inspection.

2. Phase II-IV clinical trial site inspection

3. Clinical trial research document (TMF) audit

4. Establish clinical trial SOP

5. Research institute quality management system audit

6. Data management audit

7. Statistical analysis audit

8. Clinical trial report (CSR) audit

9. Clinical trial submitted to CFDA before verification.

10. Central laboratory audit