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2017-06-23 14:51:49



Established in 1983, the Base for Drug Clinical Trial in West China Hospital of Sichuan University is one of the fourteen premier center in China. The base/GCP center consists of an institute of clinical pharmacology, Phase I clinical trial research unit/drug analytic laboratory and twelve specialized fields approved by the State Food and Drug Administration (SFDA). The twelve specialized fields are: Infectious Disease, Cancer, Psychiatry, Cardiology, Respiratory Medicine, Gastroenterology, Endocrinology, Hematology, Neurology, Dermatology, and Traditional Chinese Medicine (Respiratory and Gastroenterology). Thirteen specialized fields (Hepatology, Nephrology, Clinical Immunology, Thoracic and Cardiovascular Surgery, Urological Surgery, General Surgery, Orthopedics, Anesthesiology, Nuclear Medicine, Geriatrics, Emergency Medicine, Otorhinolaryngology, Ophthalmology) are expected the approval by the SFDA. There are more than 200 physicians and nurses who have obtained the certificates of clinical pharmacology or GCP training.

 

Since its initiation, the center has conducted more than 290 clinical investigations, including studies for 41 Category I new drugs, 69 Category II new drugs, 34 Category III new drugs, 11 imported registered drugs and 135 in other categories. The base/center has published 351 papers which has obtained 52 scientific and technological awards and recognition, including 8 at the state level, 33 at the provincial level, and 11 at the municipal level. The base/center has become one of the nine GCP centers in the nation supported by the Department of Science and Technology since 2004.

 

To facilitate the progress of each clinical trials, the center is equipped with a completed infrastructure which includes specialized units for Phase I clinical trial, Traditional Chinese Medicine, information system, biostatistics, and quality control.

 

There are 12 beds in the Phase I clinical trial ward. There are reception room for the clinical trial subjects, activity room and emergency room. Emergency cart, ECG, respiratory machine, defibrillator and some other equipment are provided.

 

There is advanced analytic equipment in phase I clinical trial laboratory, such as LC-10Advp series and LC-2010HCT series HPLC from Japan, 486 series HPLC from Waters, 3400 series GC from Varian, AxSYM and IMx automatic immune analytical instrument from US and VIVa automatic immune analytical instrument from Germany.

 

The base/ center has established an efficient administrative system to enhance the quality of clinical research activities. Standard operating procedures (SOPs) are written to standardize the process. There are independent ethic committee and scientific committee in the hospital. The ethic committee reviews and approves all research protocols involving human subjects to protect the rights and interests of the subjects.   

 

Throughout its history, the strength and inspiration of the Base for Drug Clinical Trial / GCP Center has been from its people. Every staff member plays a vital role which contributes to the delivery of the finest efforts to all aspects of clinical trials and helps stretch the boundaries of biomedical research. The dedication of our researchers has earned our center nationwide recognition. The Goals of the Base for Drug Clinical Trial / GCP Center are to:

l  Establish the finest and largest clinical trial center in the nation

l  Establish the platform for drug clinical research, especially on respiratory, cardiovascular and biotherapeutic (gene therapeutic) drugs

l  Through national and international exchange programs, participate in the international multi-center projects, and conform to the international standards for drug clinical trial.

l  Establish standard information and data management system

l  Develop cooperating and training system for drug clinical trial in western China area

 

Director:  Dr. Dejia Huang

Executive Associate Director:  Dr. Chuntao Liu

Associate Director:  Dr. Yulin Ji

Contact information:

Base for Drug Clinical Trial / GCP Center

West China Hospital, Sichuan University

 37 Guo Xue Xiang,

 Chengdu, Sichuan, 610041, P.R. China

 Phone:  (028)85422707, (028)85423655,(028)85423837

 Fax: (028)85422707






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