MAIN BUSINESS

Third Party Audit

Services Content

We have an independent Quality Assurance (QA) department to provide clinical auditing services to our clients, evaluating the quality of clinical trials, the conduct of clinical trials, the recording and analysis of trial data in compliance with trial protocols, system documentation, and drug/medical device clinical trial regulations.

Service Advantages

The audit professional team consists of full-time QA personnel and audit consultant experts with many years of experience in clinical trial auditing and its quality management system validation, who are familiar with relevant domestic and international laws, regulations and guidelines for clinical trials, and understand the guidelines for the treatment of relevant diseases. A number of the special experts enjoy a high reputation in the field of domestic and international clinical trial auditing, and some of the experts serve as the lecturers for the domestic regulatory authorities and the professional training in the field of clinical trials.

Business Details

Clinical trial site audits (including phase I-IV trials, drugs, medical devices, bioequivalence, pharmacokinetics, etc.)
Audit of Quality System of Clinical Trial Organizations and Research Centers
Audit of test data management and statistical management
Audit of third-party clinical trial service providers (including contract research organizations, sample testing units, central laboratories, etc.)