National Drug Clinical Trial Institute
Supporting unit: Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine
Professional group qualification: tumor (gynecology), gynecology, obstetrics, reproductive health and infertility
Agency leader: Lu Weiguo
Director of the Ethics Committee: Wu Ruijing
The drug clinical trial institution is affiliated to the Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine (Zhejiang Women's Hospital). Since 2009, he has received the on-site inspection of the qualification of the State Food and Drug Administration (SFDA) and obtained the formal qualification certificate for clinical trials in 2012. In 2015, the organization accepted the on-site inspection of the SFDA review and certification, and in October the same year obtained the review certificate. At present, the institute has four majors: tumor (gynecology), gynecology, obstetrics, reproductive health and infertility. It can undertake clinical trials of Phase II, III and IV drugs and clinical trials of medical devices and in vitro diagnostic reagents. Strictly in accordance with the "Guidelines for Quality Management of Clinical Trials of Drugs" promulgated by the State, "Technical Guidelines for Clinical Trial of In Vitro Diagnostic Reagents" and "Guidelines for Quality Management of Clinical Devices for Clinical Devices", the code of conduct is studied, the data is true, and traceable.
At present, there are 29 senior professional titles and 33 middle-level professional titles in the organization. Set up an office, a data room, a data archive (institutional archives), a test pharmacy/device warehouse, etc. The agency office has an independent office space that is responsible for the day-to-day work of the organization. There is an independent ethics committee to review and track the clinical trial projects undertaken. The organization uses the CTMP platform of the drug clinical trial institution project management software to carry out information management of various clinical trials.
The organization is equipped with a variety of advanced large and medium-sized diagnostic and therapeutic equipment to serve clinical trials. Such as the United States GE Hispeed series spiral CT, Germany's Siemens company's flat angiography machine (DSA), the United States GE 730 expert version of the real-time four-dimensional color Doppler ultrasound and PHILIP DR, real-time three-dimensional ultrasound diagnostic equipment, Oxford fetal monitoring network, protein purification instrument (AKTA explorer 100 system), Roche E170 type electroch emilumine scence immunoassay system. In addition, the hospital has the earliest intravenous drug distribution center in the province, which integrates formula, configuration and distribution to improve the effectiveness and safety of patients.
Each year, the organization sends more than 10 national or provincial GCP trainers, and more and more clinicians, nursing staff and other medical technicians are interested in joining the drug clinical trials.
Contact: Li Xiao, Zhao Yi
Contact number: 0571-89992206
Clinical trial management platform: http://zyfb.runtrial.net
Mailing address: No. 1 Xueshi Road, Hangzhou, Zhejiang, China
Postal code: 310006