At WuXi Clinical, we are dedicated to ensuring our quality management system is focused on controlling the specific risks identified for your study, ensuring the integrity of data and the protection and safety of human subject participants. We accomplish this by incorporating the principles of quality management, GCP guidelines, and applicable regulatory authority requirements within our standard operating procedures, work instructions, employee training curriculum guidelines and internal processes.
Our Quality Assurance program includes compliance audits, procedural and regulatory compliance, and operational synergy between all departments. This operational synergy ensures protocol compliance, identifies risks to quality, and helps identify study specific training for your clinical trial.
The quality team has more than 10 years of working experience in the field of clinical research, and in-depth knowledge and practical experience in the operation and management of clinical research projects, quality management, quality assurance and handling regulatory inspections. In China, the quality team has performed more than 150 project audits in the past several years and has successfully passed over 10 regulatory inspections from China NMPA.