Optimization Of Clinical Trial Quality Management In X Company

Clinical trials are a key stage in the development of new drugs and are a confirmatory link to determine whether new drugs can be listed.In July 2015,the former China Food and Drug Administration(now the National Medical Products Administration,NMPA)initiated the inspection of drug clinical trial data and adhered to the principle of "self-inspection and correction of errors,strict investigation and handling,severe punishment of deliberate fraud,and allow normative permission".The principle of standardization and correction is to inspect the implementation of clinical trials of drugs,confirm that the clinical trial meets the requirements of GCP and the protocol,and ensure the safety and rights of subjects.The inspections conducted by NMPA have played a very positive role in changing the atmosphere of clinical trials and raising the sense of responsibility of clinical trial participants,but they also exposed a series of problems in the performance of the responsibilities of clinical trial participants.Among the participants in the clinical trial,the sponsor company,as the sponsor,organizer,and monitor of the drug clinical trial,is one of the most important participants in the drug clinical trial,and it is also the ultimate person in charge of the quality of the drug clinical trial.The sponsor has an irresistible responsibility for quality management throughout the clinical trial design,organization,monitoring,audit,recording,analysis,summary,and reporting of drug clinical trials.This thesis only focuses on the responsibilities of the sponsor in the clinical trial,and attempts to explain from the sponsor's perspective how to manage and improve the overall quality of the drug clinical trial.The use of literature analysis,case analysis,comparative analysis and other methods of X company clinical trial quality management related organizational structure,the overall trial process,quality management activities,the quality of personnel training,the quality of document management and the electronic system for trial use The current situation is described.Company X is a start-up biological R&D company.The current quality management problems in the implementation of drug clinical trials include: lack of quality assurance department settings in the organizational structure;protocol design,enrollment of subjects,and final data processing processes are not perfect;quality control and quality assurance quality management are not played;internal and external personnel training quality is not qualified;company documents and study documents management quality is not qualified;and the electronic information system for trial use is less applied.Analyze the causes of these problems,and combine the relevant knowledge of the total quality management theory,the concept of "quality by design",and the quality risk management theory to protect the safety and rights of trial subjects and ensure the integrity of the trial data.The two core principles of accuracy,authenticity,and reliability are to optimize the design of several major influencing factors of the quality of the above X company's drug clinical trials,and to clarify the implementation guarantees and expected effects of these optimized designs.Finally,the sponsor can achieve total quality management of drug clinical trials and fully support the approval of the company's experimental drugs.In addition,this thesis has exploratory thinking on the quality management system that is specifically suitable for clinical trials.Although ICH describes the pharmaceutical quality system in Q10,the quality management system for clinical trials is different from the quality management system for pharmaceutical production.Currently,there is no clear guidance on the guidelines and regulations in the industry.This thesis describes some of the framework elements proposed by the TransCelerate organization to build a quality management system suitable for clinical trials,including processes,roles and responsibilities,partnerships,risk management,problem management,knowledge management,and documents supporting quality results.Based on the perspective of the sponsor,this thesis combines the quality optimization design of the X company's clinical trials in several aspects of the above " Man,Machine,Material,Method,Environments" and attempts to explore how to build a quality management system for the X company's drug clinical trials based on the relevant elements proposed by TransCelerate.It is hoped that this thesis could provide reference fro more pharmaceutical companies about establishing the clinical trial quality management system.