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论文编号：	8232
作者编号：	2120142552
上传时间：	2016/6/3 22:36:32
中文题目：	F公司在临床CRO市场的竞争战略研究
英文题目：	Research on competitive strategy in clinical CRO market of company F
指导老师：	武立东教授
中文关键字：	临床CRO；研发外包；竞争战略
英文关键字：	Clinical CRO; R&D outsourcing; Competitive strategy
中文摘要：	医药研发外包是将新药研究和开发过程委托给有资质的第三方来完成，其对专业技术要求非常高。对于正处于研发状态的药品来说,临床试验的结果将决定它们未来的命运,而新药研发所面临的巨大投入和研发风险，促使医药企业选择专业的CRO来完成新药研发流程中的部分环节，从而使新药研发的资金投入和潜在风险在CRO 行业的整条产业链上得到分散。这一合理分配新药研发风险与收益的内生因素带动了CRO 行业的快速成长。 2015年一系列药品监管的政策法规出台，国家对于新药物的注册和审批过程进行了更加深度额监管。这些政策法规的出台较为深远的影响了我国药品行业的发展。特别是自 7 月 22 日国家食品药品监督管理总局(CFDA)开展药物临床试验数据自查核查工作，发现许多临床研究中存在问题，比如临床研究的质量较低、研究能力和技术不到位、研究过程不严谨、不规范、甚至真实性完整性出现问题，而 CRO 作为其中重要的环节，正在面临着行业的变革，临床研究质量要求的不断提高和法规监管制度的日趋严格所带来的挑战和机遇。基于目前正值行业的快速发展期以及政策法规的快速变革期，CRO不仅需要面临并解决临床研究对其提出的更高要求，还需要注意当前法规对标准的影响，以及对CRO 公司未来的发展轨迹的影响。如何使CRO 公司在不断强化自身业务能力的同时快速适应当前变化，并做出正确的战略选择是具有较大现实意义的。通过对F公司内部资源和能力，战略定位、商业模式以及市场营销策略的研究分析，结合所学战略管理、组织与人力资源管理、市场营销等相关理论知识，深入到临床CRO这一特定市场环境，运用SWOT分析法、外部环境分析法PEST、对F公司自身特点，国内外市场情况、中国政策法规环境以及主要竞争对手等多个角度进行研究分析。为F公司制定了在临床CRO市场的竞争战略及战略保障。从而不断延伸服务链价值链，为新药研发提供全程一站式化服务，满足药企对 CRO 服务日益增长的需求，提高市场竞争力，从而得到更多的市场份额、获取更多效益并保持行业的领先地位。
英文摘要：	Pharmaceutical R&D outsourcing as a new industry in the service industry, with high technology, high investment and high added valuecharacter. In the stage of R&D, the results of clinical trials will determine the fate of their future, and new drug R&D are facing huge investment and development risk, prompting pharmaceutical enterprises professional CRO selection to complete part of the drug development process, so that in the CRO industry the whole industry chain are dispersed and potential risks of new drug research and development funding. The reasonable distribution of drug development risks and benefits of endogenous factors led to the rapid growth of CRO industry. In 2015 Chinese drug regulatory authorities issued a series of policies, review and approval of drug registration reform more and more in-depth, far-reaching influence on the future development of the pharmaceutical industry, especially since July 22nd, the China Food and Drug Administration (CFDA) to carry out clinical trials of drugs according to the number of the verification work of self-examination, exposed many problems in clinical research in the field of China. For example, research quality is not high, study behavior was not standardized, study ability is insufficient, even the authenticity integrity problems, and CRO as one of the main participants in the industry are facing changes, challenges and opportunities brought about by the strict requirements of improving the quality of clinical research and regulatory system. Based on the current industry coincided with the period of rapid development and policies and regulations of rapid change, clinical studies are also getting higher and higher requirements for the CRO, clinical research quality management standards even CRO company future development path will be affected. How to quickly adapt to changes in the current CRO continue to strengthen their own business ability at the same time, and make the correct strategic choice with great practical significance. By of F company's internal resources and capabilities, analysis of strategic positioning, business model and marketing strategy research, combined with the knowledge of the relevant theories of strategic management, organization and human resource management, marketing and, deep into the clinical CRO the specific market environment, using the SWOT analysis method, the analysis of the external environment PEST method, characteristic of the F company, multiple angles of the market situation, China's policy and regulatory environment and main competitors were studied. To develop a competitive strategy and strategic guarantee for F in clinical CRO market. To continue to extend service chain, value chain, for the development of new drugs to provide one-stop service, meet the pharmaceutical companies to CRO services growing demand, improve market competitiveness, in order to get more market share, get more benefit and to maintain industry leading position.
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