A Research On Project Management For Non Small Cell Lung Cancer Of Clinical Trial In BSD Company

In pace with the step-by-step advancement of national health care reform and the growing innovation of domestic pharmaceutical enterprises,the growth rate of listed pharmaceutical enterprises’ R&D expenditure was in a steady trend from 2018 to 2020,with year-on-year growth rates of 13%,20% and 24% respectively.But China’s overall R&D level and investment are still far behind those of developed countries,such as the United States and Japan.In particular,the overall investment level in the research of some innovative drugs is low,the R&D cycle is long,and the risk in the R&D process is high,and the probability of successful marketing of innovative drugs from phase I clinical trials is extremely low.Therefore,currently,a great number of pharmaceutical enterprises deal with this dilemma via outsourcing R&D,especially the clinical trial part of innovative drugs’ R&D project.The outsourcing model of Contract Research Organization(CRO)is a vital pathway for innovative drugs from phase I clinical trials to successful marketing.And exploring the application of up-to-date project management experience to the project management of clinical trials in CRO enterprises is one of the most essential tasks in expanding BSD Company.In this dissertation,four problems existing in the project management of clinical trials of innovative drugs in BSD Company,one of CRO enterprises,are analyzed.First,the organizational structure of the project is unreasonable.There is multiple management in the project,and the working hours of project managers and monitors can not be guaranteed.Therefore,the low operation efficiency of the organization leads to the delay of the project schedule.Second,there is a lack of effective management methods in terms of project schedule.The inability to promote the rapid initial of the hospital leads to the shortening of enrollment time and the delay of enrollment.Then,the lack of effective management mechanism of project risk can not predict and prevent the occurrence of risks in advance.Finally,the lack of project quality management system cannot deal with and improve quality-related problems in time.n light of the above problems,in this paper,the phase I clinical trial project of non-small cell lung cancer(NSCLC)of BSD Company is taken as the research case,conducting a research from organization structure management,schedule management,risk management and quality management of the project.Moreover,methods and solutions for project management of clinical trials of innovative drugs are initially given,and the project management software is suggested to be adopted to monitor the process of clinical trials,thus enhancing the project management level step by step.