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Third-party audit:

Be responsible for the audit of clinical trials, supervise and ensure that all clinical trial procedures meet the requirements of GCP, research scheme, SOP and relevant laws and regulations, find and correct problems in time, protect the rights and interests of subjects and ensure the scientific and reliable clinical trial data.

• BE, PK, Phase I trial audit

• Phase II-IV clinical trial site audit

• Clinical Trial Master Files (TMF) audit

• Establish clinical trial SOP

• Research institution quality management system audit

• Data management audit

• Statistical analysis audit

• Clinical study report (CSR) audit

• Pre-submission audit of clinical trials to NMPA

• Central laboratory audit