Research On The Project Quality Management Of The Information Platform Of Clinical Trial In AA Medical Group Group

Drug clinical trials need to go through a longer period of time and require too much capital investment,and take higher risk.At the same time,the number of units and personnel involved is also large,which requires strict supervision and risk control.At present,about 90%of the clinical trial management methods in China are relatively backward.In view of this phenomenon,the state food and drug administration made many laws and regulations to regulate the supervision and management of clinical trials,promoting the upgrading and transformation of clinical trial r&d enterprises and hospitals and other research and development units,such as new informatization,integration and intelligent functions,shortening the research and development cycle of clinical trials,improving the use efficiency,reducing the risk of drugs,and saving the cost of research and development.As a leading industry company in China,AA Pharmaceutical Group needs to build an information-based platform for clinical trials as its development expands.After conducting market research,AA Group commissioned BB Technology Co.,ltd.to develop an information-based platform for clinical trials.The paper mainly uses literature analysis and case study.First of all,it introduces the related theory knowledge,which mainly reviewes the project management,IT management,project cycle theory and quality management,etc.Secondly,based on the project management and quality management theories,this paper analyzes the actual situation of the construction quality management of the clinical trial informationization platform of AA Pharmaceutical Group,and then designs and implements the project requirements analysis stage,design stage,implementation stage and follow-up maintenance stage,and puts forward targeted feasibility suggestions.Finally,the quality management guarantee measures are listed from various aspects to the construction of the information-based clinical trial platform of AA Pharmaceutical Group.The purpose of this paper is to put forward a feasible quality management method and measure to the AA Medical Group clinical trial information platform project.To provide some theoretical basis and practical guidance for the quality management research of the domestic clinical trial information platform project.