一体化信息技术在临床研究中的应用

Application of Integrated Information Technology in Clinical Research

利用信息化技术提高临床研发的效率与质量已经成为制药企业发展的必然趋势。临床研究信息化系统因监管要求严格、使用人员众多、临床研究工作分工细、工作流复杂等特点,同一个临床研究项目需要使用不同的信息化系统,各系统因缺乏信息交互,常造成信息孤岛,增加了许多重复工作,严重地影响了数据的使用效率,也不利于大数据的信息挖掘。本文以符合监管机构要求、满足临床研究业务需求为前提,探讨临床研究一体化技术建设在制药企业的实践,以期提升临床研发效率。

Using information technology to improve the efficiency and quality of clinical research has become an inevitable trend in the development of pharmaceutical enterprises.Clinical research information system is characterized by strict regulatory requirements,numerous users,fine division of clinical research tasks and complex workflow.Different information systems are,therefore,required in a single clinical trial.The lack of information sharing among different systems often results in isolated information island and repetition of work,which seriously affect the efficiency of data use and are not conducive to information mining with big data.This paper discusses the practice of technology integration in clinical research settings by pharmaceutical enterprises that meets regulatory requirements and satisfies clinical research needs,with a view to improving the efficiency of clinical R&D.