Clinical Trial Unit of FUSCC is one of the clinical trial bases which is first approved by China Ministry of Health in 1983, confirmed by SFDA in 2005, reconfirmed by CFDA in 2010,2015 respectively. We set up GCP office, documents storage room, clinical trial pharmacy in 2004. The specialties in oncology and medical imaging were certified and recertified by CFDA. The Phase I Clinical Trial Unit was approved by SFDA after the field inspection. In September 2011, the Phase I Clinical Trial Unit worked with the South Texas Accelerated Research Therapeutics company (START) and established the FUSCC-START Phase I Clinical Trial Center.
We build up clinical trial quality assurance system, regulations and SOP and update timely. The unit supervises all the clinical trials conducted in FUSCC and takes in charge of GCP and other clinical research training and staffs. After years of training and practicing, we have built a nationwide professional team with high-level of medical knowledge for clinical cancer research.
Since the establishment of the Clinical Trial Unit, we have undertaken 1000 clinical trials for global multi-center, phase I clinical trials and pharmacokinetic studies for innovative domestic drugs, and multi-center clinical trials for registered domestic drugs and investigator initiated trials.
Laboratory of Phase I Clinical Trials
Our laboratory is an active research department within the Fudan University Shanghai Cancer Center. We focus on clinical pharmacokinetic research in phase I clinical trial of new investigational anticancer agents, including:
Sensitive and specific LC-MS/MS based bioanalytical method development for quantification of anticancer agent and its active metabolites in blood and urine of patients.
Human pharmacokinetic and pharmacodynamic evaluation of new compound in First-in-Human study.
PK/PD modeling and simulation for dose regimen optimization in anticancer chemotherapeutics
Currently, there are 5 staffs in the laboratory. We provide bioanalytical services and clinical pharmacokinetic research for phase I clinical trials of new drugs. The quality management system is developed and implemented according to the requirements for the Testing Laboratories Competence (ISO17025), to guarantee test result validity, and satisfy the demands of clients.
Please contact us if you require further information.
Yan Sun, Ph.D.
Laboratory of Phase I clinical trials
Tel : (8621) 64175590 Ext. 81112
Fax : (8621) 54268173