浅谈重大新药创制专项实施下的药物临床试验机构建设

自新药创制重大专项实施以来，医院加强了对软硬件的投入，药物临床试验机构开展了大量的工作，加强对临床试验质量全流程的管理、修订各项管理制度和标准操作规程，构建信息化管理平台，申请多项国际认证体系的现场认证。本院临床试验研究和管理水平有了显著提升，确保了临床试验运行管理的高效能，使药物临床试验操作更规范，临床试验质量显著提高。

Brief introduction on construction of drug clinical trial institution construction under the implementation of major new drug innovation and development

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 onsite certification.The capability of research and management in clinical trials had been significantly improved,ensured the efficacy in operation and management in clinical trials.