The Research On Development Of Pharmaceutical R&D Outsourcing Service Industry In China

Objective:The aim of this study is to solve4problems, first is to look for the theoretical foundation of the pharmaceutical R&D outsourcing industry; second is to know the necessity, feasibility and market competition on the Chinese pharmaceutical R&D outsourcing industry; third is to clear at present problems in the development process of the industry in China, specially clear the situation of the Chinese industry professionals; Fourth is to put forward to the strategy and pathway about industry.Methods:System study, normative study, empirical study, case study, intensive interviews, focus group discussions and son on. the main study is empirical study based on the normative study.Results and Conclusions:1.verify the idea that pharmaceutical R&D outsourcing industry is a new industry and the theoretical foundation of the pharmaceutical R&D outsourcing industry. The first is to make clear the concept of CRO and it’s functions and the analysis of driving factors of pharmaceutical R&D outsourcing industry; and then we verify the idea that "pharmaceutical R&D outsourcing industry is a industry" which can clear the thought of people; The last is make the theory of social division of labor, transaction cost, comparative advantage, the core competence of the corporation and resource-based view as the theoretical foundation of the pharmaceutical R&D outsourcing industry.2. The comparative analysis on domestic and foreign pharmaceutical R&D outsourcing industry in the demand of global market, market scale, marketing, main CRO and developing trend.From PEST analysis model (political, economic, social, technological), the market of Chinese pharmaceutical R&D outsourcing industry has great potential. But porter’s five forces model on the market competition situation analysis shows that the threat of the bargaining power of buyers, bargaining power of suppliers, rivalry and new entrants is larger, and the threat of substitute is smaller.3. The present situation of Chinese pharmaceutical R&D outsourcing industry, especially about the industry professionals, first of all, an exploratory case study analysis the dilemma and its measures which TG company as native CRO have to face. At the same time, through in-depth interviews and focus group discussions show that native CRO face the existing problems and its solution. Above study shows industry professionals, the quality of clinical trials and the unsound relevant industrial policies, laws and regulations is the important factors for native CRO, especially the shortage of industry professionals has become key factor in the Chinese pharmaceutical R&D outsourcing industry. In order to know the present situation and training needs of industry professionals,3cross-sectional surveys was conducted.①Current situation analysis on cognition of CRA on clinical trail and its educational demands;②Investigation on satisfaction degree of clinicians on CRA;③Current situation analysis on cognition of clinicians on clinical trail and its educational demands, which show that the knowledge and occupation quality of industry professionals can not meet the demand of occupation, and now training system isn’t ready.4. In order to promote the Chinese pharmaceutical R&D outsourcing industry sustainable development, there are discussed strategy and specific measures on industrial development, which is the perfect industry policy, strengthen industry regulation and supervision, establish the training system and the industrial development pathway.