Quality Assurance & Audits

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. As more and more Multi-Regional Clinical Trials (MRCT) are conducted in China, it has never been more important for local CROs to conform to ICH standards. Luckily for CSC, we have incorporated it in every aspect of our work since establishment.

Our Quality Assurance & Audit team is composed of audit consultants and full-time QA personnel, has an average of more than 15 years of experience in global and local clinical trial projects, more than 10 years of experience in clinical trial audits and Quality Management System verification. Many of our QA team are experts nominated by FDA and EMA. Some of them have also served as experts or trainers of local and foreign regulatory authorities, as well as professional training in the clinical trial training sites.

Our auditors are familiar with global clinical trial laws, regulations guidelines and understand relevant disease treatment guidelines, and have rich practical experience in clinical trial design and planning, implementation and supervision, data collection and analysis, quality control and quality assurance, auditing and meeting pharmacovigilance inspections.