关键词: 信息化管理, 药物临床试验, 药品监管, 上海

Abstract:

Informatization management is a crucial approach to enhancing the efficiency and quality of clinical trial supervision. Advancing the informatization of pharmaceutical supervision can improve the transparency， efficiency， and safety of clinical trials， thereby strengthening drug safety assurance. To comprehensively elevate the supervision efficacy and quality of drug clinical trials， Shanghai has actively explored the application of informatization management in the supervision of drug clinical trials and has established the "Data Supervision Platform for Drug Clinical Trials". This platform aims to provide a foundation for dynamic， full-process supervision of clinical trials and to continuously refine a scientific， precise， and efficient regulatory system. This study reviews the background of the development of informatization in the supervision of drug clinical trials in Shanghai and the information on existing drug clinical trial registration platforms， summarizes the practical applications and current status of informatization management in the supervision of drug clinical trials in Shanghai， analyzes its positive impacts on improving regulatory efficiency and ensuring the quality and safety of clinical trials， and discusses the challenges faced by the current platforms， including communication mechanisms， data security， data standardization， business collaboration， data analysis， and talent cultivation. The study focuses on exploring how to utilize informatization management to promote the modernization of drug clinical trial supervision and how to integrate informatization deeply with drug supervision to lead the modernization of drug supervision through informatization， and put forward suggestions for future development directions.

Key words:  , Informatization management； , Drug clinical trial； , Drug supervision； , Shanghai