| The pharmaceutical industry is an industry with long cycles,high risks,and high returns on high investment.Since 2015,with policy support and technological advancement,a massive influx of capital has resulted in opportunities and challenges for pharmaceutical companies.Due to major barriers and costs,professional outsourcing services have flourished.Pharmacovigilance during the clinical trial is currently one of the fastest growing modules of outsourcing services.This study is guided by Total Quality Management theory,using literature research method and questionnaire survey method to extract and sort out the influencing factors of outsourcing service quality for CRO clinical trial pharmacovigilance,and 28 quality influencing factors are obtained,including 9 personnel factors,3 hardware and software factors,3 material factors,7 method and regulatory factors,and 6 environmental factors.AHP(Analytic Hierarchy Process)and questionnaire survey were used to pairwise compare the weights of the influencing factors at each level,and the order of the weights of each factor of the criterion layer to the target layer was as follows:personnel factors>method and regulatory factors>software and hardware factors>material factors>environment factors;The 12 factors in the top 50%of the the program-layer factor wight,the order is:comprehensive,detailed SOP>comprehensive implementation rules and guidance documents>regulatory and institutional requirements in line with international standards>comprehensive literature search database>efficient pharmacovigilance system>CRO pharmacovigilance staff:full-time or not and clear responsibilities>CRO pharmacovigilance staff:pharmacovigilance work experience>efficient communication mechanism with relevant parties such as the sponsor>CRO pharmacovigilance staff:continuous Training>Pharmacovigilance supervision and punishment system>CRO pharmacovigilance staff:knowledge and attitude towards pharmacovigilance>CRO pharmacovigilance staff:professional background>efficient safety signal monitoring and evaluation system>traceable report data.According to the research results,this study puts forward targeted suggestions on improving the outsourcing service quality of CRO clinical trial pharmacovigilance s from five aspects:"Man","Machine","Material","method" and "Environment",Man:establish a pharmacovigilance department and clarify the scope of responsibility;strengthen the recruitment of high-level pharmacovigilance personnel and continuous training of employees;strengthen the cognition and attitude of pharmacovigilance personnel and improve the professional requirements of pharmacovigilance personnel;Machine:establish a comprehensive literature search database;establish an efficient pharmacovigilance system and security signal testing and evaluation system;Material:strengthen the training of SAE report filling to ensure the traceability and comprehensiveness of the data;standardize and strengthen the use of medical English dictionaries;Method:improve the SOP of CRO clinical trial pharmacovigilance,promote the comprehensiveness and refinement of SOP;improve the supervision system and guidelines in line with international standards,refine the punishment system;establish and improve the communication mechanism and business continuity plan of related parties;Environment:improve the quality management system of CRO clinical trial pharmacovigilance,strengthen compliance management;establish auxiliary assessment and audit organization. |
