The quality assurance department is independent of all aspects of clinical trials and consists of personnel with many years of clinical trial experience. The team has rich audit experience and a comprehensive training system. The project experience covers phase I-IV, and the indications involve oncology, ophthalmology, endocrinology, gynecology and neurology, etc. Provide a full range of professional assurance for the whole project quality control of customers.
In accordance with domestic and international clinical trial regulations and requirements, Bna quality assurance department has established a comprehensive clinical research standard operating procedures (SOP), and is constantly improving. Through elearning self-learning system, professional skills training and skills sharing are carried out regularly. Through CTMS system and TMF system independently managed, the project management ability will be strengthened to efficiently perform inspection, rectify deviation and timely control risks for the bid party. In accordance with the relevant regulations and the Requirements of the Berneria SOP/ sponsor SOP, the Quality management team of Berneria conducts timely and efficient audit of the clinical trial project, ensures the cooperative operation of the clinical trial, reports the problems found in the audit, and requests the subject to respond to corrective and preventive actions and submit to QA audit.