Drug Clinical Trial Institution of Peking University School of Stomatology
In 1998, the drug clinical trial institution of Peking University School of Stomatology (‘the institution’ for short) was a clinical pharmacology base of oral medicine among the first bases list approved by the Ministry of Health, also was the pioneer undertaking the clinical trials of oral medicine in China. In 1999, the institution was approved as one of the national drug clinical research bases by the State Drug Administration. In 2006, the institution was issued the certificate for medical institution conducting clinical trials for human used drugs by the State Food and Drug Administration (Certified therapy area: oral medicine). In 2012 and 2015, the institution passed the qualification inspection of drug clinical trial institution and was issued the certificate by the China Food and Drug Administration (Certified therapy area: oral medicine). In December 2018, according to the new requirements of CFDA, the institution had registered the clinical trial institution qualification of medical devices.
Our duties include the clinical trial operation management, investigator training and providing professional technical guidance. We are engaged in building a high-quality clinical trial support platform and providing comprehensive professional technical supports and services for clinical trials investigators.
The institution is qualified to carry out phase II-IV drug clinical trials and clinical trials of medical devices. Up to now, our hospital has undertaken clinical trials of drug or medical device in 6 specialties (including Oral and Maxillofacial Surgery, Oral Medicine, Periodontology, Prosthodontics, Cariology and Endodontology and Preventive Dentistry). Due to the characteristics of diagnosis and treatment of oral diseases, our clinical trials mainly focus on imported and domestic class III medical devices. Since 2012, the institution has undertaken 25 clinical trials, including 4 drug clinical trials and 21 clinical trials of medical devices. Some products of them have successfully been issued the product registration certificate.
The institution attaches great importance to the quality of clinical trials, constantly optimizes the management system and standard operating procedures of clinical trials, gradually establishes the clinical trial quality management system, and fully protects the rights and interests of the subjects. In addition, the institute also pays attention to the training of investigators, and has organized 304 investigators to participate in the GCP and related technical training.
In the future, the Institute will continue to strengthen the operation management of clinical trial, promote the implementation of clinical trials standard and continuously improve the quality of clinical trials, to ensure our hospital’s clinical trials reach the top level in China. The Institute will provide comprehensive, professional and high-quality technical supports and services for both investigators and sponsors of clinical trials, as well as contribute to the innovative research and development of drugs or medical devices for oral medicine.
The leader of institution:Deng Xuliang
Contact person:Hua Hong
Office secretary:Liu Yan
Address:No. 22, Zhongguancun South Street, Haidian District, Beijing
last text: Dental Medical Devices Testing Center