Clinical Research Center
The Clinical Research Center and the National Drug Clinical Trial Agency passed the qualification certification of the drug clinical trial agency of China Food and Drug Administration in August 2008, specializing in tumor. The center has successfully passed the qualification review in October 2014 and May 2017.
The Drug Clinical Trial Agency is composed of the General Office, Oncology Department, Phase I Trial Ward, Oncology Key Laboratory, and New Drug Storeroom. The oncology department includes 10 departments: Department of Oncology, Gynecologic Oncology, Urology Oncology, Breast Oncology, Hematology Oncology, Head and Neck Oncology, Neurooncology, Tumor Radiotherapy, Gastroenterology and Oncology.
The hospital has a clinical research management committee and an ethics committee, which is responsible for the establishment and ethical review of drug clinical trials, ensuring the clinical trial projects being scientific, and protecting the safety and rights of subjects.
The general office is responsible for the daily affairs of the entire organization. It has an independent office, equipped with full-time management personnel, complete office facilities, and perfect management system and SOP.
The faculty in Oncology Department has have passed the GCP training for more than 300 times, and all obtained the certificate, which ensures the quality of the trial. The hospital's Phase I trial ward was officially put into use in July 2018. It has 50 beds, equipped with information rooms, blood collection areas, phase I test pharmacies, drug preparation rooms, sample processing and storage rooms, data rooms, and monitoring rooms District, professional research team.
The hospital implements centralized management of clinical trial drugs. The new drug warehouse is equipped with professional drug administrators, complete drug storage equipment, temperature control systems, and independent electronic test drug management systems to manage the test drugs in a standardized manner.