The Clinical Trial Center is CFDA Certified and offers different services to improve Scientific and Ethical standards of Anticancer Drugs Clinical Studies. Meeting the National and ICH GCP Requirements, the center carries out research to support clinical trials out to improve the National Pharmaceutical R&D.
The Clinical Trial Center manages the clinical trials within the Phase I Unit which employs 26 people and offers 12 beds. It also takes care of Data Management, Bio-statistics, the GCP Training Program, Post-Marketing Research and Clinical Epidemiology.
The CTC conducts the following range of actions:
- Hospital-wide clinical research involving the human body (drugs, equipment, diagnostic reagents, non-registered clinical studies, etc.) for project management, program audit, ethics submission, quality control, summary reports and other audit signature
- Participation in all clinical trials, such as sending doctors, research nurses, SAE collection, etc.
- Drug, data management or supervision
- Conducting Phase I pharmacokinetic experimental drugs study, therapeutic drug monitoring
- 5010 project reporting, quality control, and management of daily operations
- Statistical analysis of some projects; providing experimental design, statistical analysis and other consulting
- GCP training techniques and clinical trials
- DME/Evidence Based Medicine course for graduate student