Optimization Of Clinical Trial Quality Management In Company M

The quality of a clinical trial is crutial to new product registration,which is also the most important section that the National Medical Products Administration focuses on.Besides,the results of annual random inspection of the medical device clinical trials revealed that there were still multiple quality management issues in the clinical trials.As the initiator and management of a clinical trial,the sponsor is the ultimate responsible person for the quality and reliability of clinical trial data.Sponsors have inescapable responsibilities for the quality management of the whole process in a clinical trial,as well as ensuring the authenticity and compliance of clinical trials.This study takes M company as the object and attempts to explore how to effectively improve the quality management of clinical trials from the perspective of sponsors via literature analysis,case study,PDCA cycle method and interview method.The current problems in the quality management of clinical trials in Company M include unreasonal protocol designation,low quality of clnical data,low on-scheduled completion rate of clinical trial,low quality of clinical essential documents,high unqualified rate in audit activities.Based on the theory of Total Quality Management,the major factors affecting the quality are the five aspects,this thesis analyses the reasons from the above five aspects and the results are shortcoming of organization structure,insufficience training for quality management employee,lack of quality management for essential documents,imperfection of quality evaluation system,insuffictience in quality control system,insuffictience in corrective and preventive action management and week awareness of quality management.On the basis of problem analysis,combined with the knowledge of Joseph M.Juran’s Quality management theory and Total Quality Management theory,the study is going to optimize the organizational structure and quality management system from four main factors,including adjusting the organizational structure,improving the training system,improving document quality management,improving the quality review system,strengthening the quality control system,optimizing the corrective and preventive action requirements,expounding the guaranteed measures and expected results,and strengthen the quality awareness of all employees.This thesis considers that establishing an efficient communication organization and emphasizing the important role of project managers in clinical trial can lay the foundation for the efficient operation of clinical trials,a complete training system can ensure the personal ability of quality management personnel and ensure the practical implementation of quality activities;standardized clinical trial document quality management can effectively ensure the integrity and compliance of clinical trial documents;a sound quality review system promotes the continuous optimization and improvement of the clinical trial quality management system.It can ensure the quality of the key stages of clinical trials.At the same time,it can effectively ensure the quality management of the whole process of clinical trials with standardized,wholeprocess quality control means and execu Table.corrective and preventive actions,which can effectively secure the quality of the clinical trial.By enhancing the quality awareness of all staff,establishing the concept of "quality starts from me",and ensuring that all clinical trial work is done in a right way at the beginning and maintained during the process,the quality of clinical trials can be greatly guaranteed.Finally,sponsor can set up a quality management system with all employee participation,comprehension and entire process covering.