Outsourcing Risk Management R&D Of Pharmaceutical Enterprise

In recent years, domestic pharmaceutical innovation conditions are gradually improving, and pharmaceutical industry have developed rapidly with support of the policies. The investment in R&D have also enlarged, in order to survive and grow in the harsh competition. Under the stimulation of the internal and external causes, market of outsourcing developed in high-speed. The size of the market for outsourcing increased from Increased from3billion in2006to13billion in2010. The pharmaceutical enterprises are paying more and more attention to the strategic position of outsourcing.R&D of new drug is a complicated systematic project, involving a wide range of scientific fields and the latest technology. It is haracterized by large investment, long time, the low success rate. By outsourcing in R&D, enterprises get the new technology or new product rapidly. It also brings the risk to Pharmaceutical enterprises.The company should not only in the face of internal drug development characteristic and enterprises of various uncertain factors, but also in the face of CRO company’s. Without valid and rational risk responses, all of these will affect the normal operation of the enterprises, will be serious or even fatal blow to the enterprise.This paper introduced the transaction cost theory, principal-agent theory and the social exchange theory in the chapter of the motivations and rationale of CRO. Through analysising of the literature and practice, it brings out that the mainly risks in outsourcing:the project itself and outsourcing. Through the theory of risk management, using the theory of fuzzy mathematics and related disciplines in the practices of risk management, from the point of pharmecetical enterprise, identified the risk in the different stages of outsourcing by using Delphi and brainstorm method.By risk analysis of outsourcing,this paper demonstrate risks of outsourcing that may experienced. Combinning the practices of risk management, pharmaceutical enterprise can build the risk evaluation system of R&D for enterprises by qualitative and quantitative methods. How can the pharmaceutical enterprise do in strengthening risk management, while using outsourcing to enhancing the competitiveness of enterprises.Studies show that the improvement of the framework of risk management, process in risk management and construction of risk evaluation system, and combining with management and controlling in the whole process, can the risk be redcuced. Based on the practice in the company, some effective measures is recomendede to enhancing risk management from strategic level,management level and operational level.Only through the total management of R&D outsourcing, the pharmaceutical enterprise can carry out effecitive management and to achieve the purpose of reducing risk.