Centre Laboratory Service Management Based Upon The Project Management Body Of Knowledge

Drug Clinical trial,which is for the benefit of patients,evaluate drug's safety and efficiency based on laboratory data,and with development of this industry,the amount of clinical trial is becoming much bigger and the trial protocol is getting more complex.In recent years,drug development globalization is increasing,the multi-center clinical trial,especially international multi-center clinical trial has become the trend of future of drug development.In the meantime,Centre laboratory,with its advantage of centralized processing data,international standard,full quality assurance and standard of process system,and high quality data management,has become the first choice of clinical trial,especially for international multi-center clinical trial.Centre laboratory has become increasingly critical in clinical trial;therefore,efficiency management of laboratory services is bound to become the development trend of clinical trial requirements.The Project management has been widely used in various industries and fields and effective,but we didn't see any systematic application research for centre laboratory service,the main purpose of thesis research is to analyze the project management knowledge among the central laboratory service applications,to improve the centre laboratory business management.Centre laboratory is an important part of clinical trial,the laboratory service depends on clinical trial protocol,but the service is different with clinical trial,it focus on test analysis and high quality data delivery,the difficulty is for different clinical trial the required complex,testing,scheduling,sample type,turnaround time and etc.must match and combine with the final delivery of data,which requires centre laboratory to have the capability to build the unique database and data management.This article reviews the body of project management knowledge,the nature and characteristics of centre laboratory business,and the issues encountered in practice,then combined the knowledge and business together in-depth.With the cue of project lifetime,the article provides a detailed analysis of the application of project management knowledge in a laboratory project,the analysis is based on laboratory characteristics and focus on scope management,time management and risk management.In conclusion,by analyzing and practice the project management application,the issues encountered in practice was resolved,the management efficiency and project outcome quality were improved,and finally summarizes some important points for laboratory project management which includes: the scientific review is a necessary phase before project launch;the timeline plan should be consistent with clinical trial;the importance of laboratory database design and it links with scope management during project plan phase;the monitoring plan is essential during project plan phase;laboratory data transfer management do not require time urgency;the applications of organizational process assets is important and useful.