Studies On Project Risk Management Of Drug R&D Company

The contract research organization(CRO)originated in the United States in the 1970 s,and the early CRO companies were small.In the 1980 s,with the continuous improvement of drug control regulations by the US government,the requirements and supervision on drug R&D became increasingly strict,drug R&D became more difficult,and the cycle became longer.More and more pharmaceutical companies began to entrust some work in drug R&D to CRO.After decades of development,the current service scope of CRO industry basically covers all stages and fields of new drug development,and has become an indispensable link in the pharmaceutical R&D industry chain.Based on the project risk management theory and reviewing a large number of documents,this paper takes JS Company as the entry point,researches and establishes the risk management model of the new drug R&D project of CRO,and applies the model to RD02 project for demonstration.Through risk planning,risk identification,risk analysis,risk response and risk monitoring process,the risk management process for JS Company's new drug R&D project was established.Through the research on the new drug R&D project of JS Company,this paper draws the conclusion that the factors influencing the risk of new drug R&D project include financial risk,management risk,technical risk,production risk,market risk,policy risk and EHS risk.At the same time,it discusses how the company conducts risk management and risk response measures throughout the process to achieve the goal of reducing risks.This article is based on the case study of JS Company's RD02 pharmaceutical intermediate R&D project,which has practical guiding significance for the future development of similar projects by JS Company.It also enables JS Company to accumulate systematic risk management experience of drug R&D projects.It complements the company's existing project management capabilities and guides CRO to continue healthy development in a competitive environment.