Audit

Through systematic review of clinical trial related activities, records and documents, it is confirmed whether the data, analysis and reports in the process are complete, correct and credible, and whether the rights and interests of subjects meet the GCP and related requirements. Department of Quality assists in various services from trial initiation, planning, execution, maintenance, data analysis to completion of clinical trial reports, in compliance with international regulations such as ICH guidelines and local regulations. It also confirms the top service quality through internal audits. We also provides external audits to assist clients in ethical and scientific aspects in compliance with international regulations.

• Phase I – IV GCP Audits

• Site Audits

• Investigational Product Labeling and Packaging Process Audits

•Clinical Database Audits

• Vendor Audits

• Internal System and Process Audits

• Essential Documents Audits