关键词: 重大新药创制, 临床试验, 机构建设, 质量管理

Abstract: In order to investigate the construction of drug clinical trial institution under implementation of “Major New Drugs Innovation and Development”, sharing our experience of management of drug clinical trial institution and project implementation. Since implementation of major new drugs innovation and development, our hospital increased investment in software and hardware, drug clinical trial institution carried out a large number of work to strengthen the quality of the whole management process of clinical trials, revision of the management system and standard operating procedures, building information management platform, Application a number of international certification system on-site certification. The capability of research and management in clinical trials had been significantly improved, ensured the efficacy in operation and management in clinical trials.

Key words: major new drug innovation and development, clinical trial, institution construction, quality management