Contract Research Organizations (CROs) arose from the US during the period from the late 1970s to the early 1980s. It has brought the whole new changes to the Chinese health market since it formally entered China in the late 1990’s. An incandescent power was being proved into our pharmaceutical industry. Since this fresh organization was born, the discussion around it has never ceased. Recently, CROs have aroused great interest of our society, especially with numbers of China-based CRO companies who were listed in the past 5 years. This study is based on the theory of business model and sectoral system of innovation with the methods of questionnaire investigation and case study research. It tries to present three aspects from a 2009 to 2013 Chinese perspective: the situation of CROs’ industry, the business models of different CRO firms, industry envolution of CROs based on sectoral system of innovation. This thesis aimed to explore the status and perspective of Chinese CROs and the industry envolution and drivers. Three main conclusions may be drawn in this research. Firstly, different ownerships of CRO firms have different expressions on business scope, strategy choice and performance evaluation according to the questionnaire survey analyze method. Furthermore, based on the analysis dimensions, value proposition, value chain and value network are the leading driving forces for the business model of CROs. Four typical business models were recognized in this thesis: 1) providing whole value chain service; 2) concentrating on pre-clinical service; 3) concentrating on clinical service; 4) primary serving the local customers. Their value proposition, value chain, value network are expanding. Another finding is that China-based CROs have healthy living environment and broad space for development in the background of current state policy scenarios, pharmaceutical industry, universities, scientific research institutes and hospitals. At last, this study argues that Chinese CROs is a rapidly changing without fixed form and may possibly follow diverse directions to develop. Three recommendations are also provided for the latecomers of CROs in China. In the first place, CRO firms should set up short-term developing plan base on the core business and technology and not hook on expansion. Then, they ought to respond resiliently to the unknown，undergo a subtle change pharmaceutical industry, and break away from tradition to quest for new business models. Finally, China-based CROs should make good use of state policy resources, and strictly abide by the relevant laws and regulations and the relevant industry rules of CROs. What’s more, latecomers could cooperate more with related industrial sectors to search for new developmental chances.

Contract Research Organizations （合同研发组织，CROs）兴起于上世纪 70 年代末 80 年代初的美国，于 90 年代末期进入中国市场。它的出现，给整个健康 产业带来了全新的变化，为制药产业注入了一股炙热的力量。自这个新的组织形 式产生之日起，关于 CROs 的讨论就从未停止过，特别是随着多个中国 CRO 公 司的上市，更是让这个产业得到了社会各界关注。 本研究通过中国视角，运用问卷、案例研究以及与商业模式和部门创新系统 理论相结合的方法，对中国 CROs 自 2009 年到 2013 年的产业整体现状、商业模 式形态、部门创新体系框架下的产业演进三个方面进行全面剖析。希望能在事实 的基础上结合理论知识对中国 CROs 进行多维度的呈现，目的是为了探析中国 CROs 产业的演进路径和动力。 本研究各部分相互关联，紧绕“中国 CROs 产业演进及动力”的主题，从时 间轴上展开研究。通过对问卷的分析发现：不同所有制的中国 CRO 公司在业务 类型、战略选择和绩效评价上有明显的差异。在对案例的研究中又发现：价值主 张、价值链、价值网络是影响 CROs 发展的三个重要维度，并总结出四个中国 CRO 公司的主要商业模式，它们分别是：提供全价值链服务、专注于临床前试 验、专注于临床试验和服务于本土客户四种模式，并发现中国 CROs 的价值主张、 价值链、价值网络正在进行着扩张变化。最后，在部门创新体系的理论框架下， 研究通过对政策和法律法规以及行业规范、制药企业、大学和科研院所以及医院 三个角度的讨论来探析中国 CROs 的演进路径和发展动力。 最后，本研究认为 CROs 是一个急剧变化发展中的产业，它目前没有一个固 定的形态，未来可能朝着多个方向发展。对中国 CROs 产业参与者和潜在进入者 提出了三点建议：首先，制定短期发展战略，立足核心业务和技术，不要盲目扩 张；其次，灵活应对正在发生变化的制药产业格局，突破传统观念，寻求不同形 式的商业模式；最后，应该合理运用国家政策资源，遵守相关法律法规和行业规 范，多同相关产业部门合作，谋求新的发展契机。