合同研究组织的现状和未来  

The Present Status and Future of Contract Research Organization

作　　者：赵健[1] 邱家学[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京210009

出　　处：《药学进展》2007年第2期86-90,共5页Progress in Pharmaceutical Sciences

摘　　要：合同研究组织是近年来兴起的一个行业,这一产业正在全球范围内迅速发展。目前全球共有500多家合同研究组织,为新药开发过程控制、费用控制、风险控制起着巨大作用。其在中国还处于起步阶段。中国的合同研究组织面临着机遇和挑战。合同研究组织作为一个新生事物,必将开创研发创新的新局面,政府应加大扶持力度。鼓励开办各种形式的合同研究组织,从政策法规上加以科学引导。合同研究组织也应不断积累经验,学习提高自已,在严谨、科学、效率等方面创出品牌,争得市场。还应建立自已的数据库以便进行数据管理、处理、统计,利用计算机管理,在在线公开临床数据等方面探索先路。As a new profession, Contract Research Organization （CRO） industry was developed pretty quickly in recent years globally. More than 500 CRO companies play an important role in operation control, cost control and risk control of drug development all over the world. CRO industry is still on its early stage in China, which means opportunities and challenges exist simultaneously in this profession. CRO will undoubtedly promote the drug research and development to an unprecedented status. CRO industry should be supported strongly, encouraged to set up various types and guided by related policies and regulations. CRO companies should keep collecting and summarizing experiences to improve, and building brands in preciseness, standard and effectiveness to gain more market share. CRO companies should also set up their own databases to manage, analyze data, and explore in publicizing clinic experiment data by information systems.

关 键 词：合同研究组织 新药开发 委托开发 联合开发 

分 类 号：F203[经济管理—国民经济]