Study On Quality Control Strategy Of Drug Clinical Trial Outsourcing Supplier In S Company

For pharmaceutical enterprises,new drug R & D is very important for the survival and development of an enterprise,and drug clinical trial is an important part of new drug R & D.because this part is opened in the research centers of many hospitals in the country and even in the world,the cost of manpower,time and money is very huge.At present,in order to speed up the development of new drugs,more and more pharmaceutical companies outsource the clinical trials of new drugs to cro companies.This outsourcing mode can not only speed up the progress of drug clinical trials,but also save some reseach and development costs.However,there are a series of problems in the process of drug clinical trial outsourcing,which may delay the progress of clinical trial,or seriously affect the success or failure of the whole clinical trial.Therefore,for the outsourcing suppliers of clinical trials,especially cro companies,pharmaceutical companies need to carry out quality control.This paper combines the relevant theories of quality control,supplier management,supplier quality control,and regulations related to drug clinical trials,taking s company as the research object,we carried out the research on the quality control strategy of drug clinical trial outsourcing suppliers.This paper first expounds the concepts and related theories of outsourcing supplier,quality control,supplier’s quality control are expounded from the theoretical level and regulations.Secondly,taking s company as an example,combined with the actual situation of drug clinical trial outsourcing supplier quality management in the company,combined with questionnaire survey and in-depth interview,the existing problems and reasons were analyzed.On this basis,combined with the recommendations of expert in-depth interviews,the quality control strategy of drug clinical trial outsourcing supplier of S company was formulated.This quality control strategy is implemented for two projects in progress,and the effect of quality control strategy implementation is evaluated.This study will provide some reference for the quality management of drug clinical trial outsourcing suppliers of the same type of domestic pharmaceutical enterprises to a certain extent.