Research And Implementation Of Clinical Trial Management System Based On Hybrid Cloud

As an important stage in drug development,clinical trial is an important means to improve the development level of medical science and technology.How to achieve standardized management of clinical trials is the key to simplify research links,improve research quality,ensure accurate,reliable and complete test results,effectively shorten the cycle of new drug research and development,and speed up the process of drug registration.Thesis studies the design and implementation of clinical trial management system(CTMS)based on hybrid cloud architecture.Through in-depth investigation and analysis of the requirements for the whole process management of clinical trials,an integrated CTMS was designed and implemented,there are seven subsystems including three levels of project approval and review management,clinical trial operation management and system background management: clinical trial project management system,clinical trial ethical review management system,clinical trial subject management system,clinical trial investigational product management system,clinical trial financial management system,clinical trial quality management system,authority and system maintenance management.At the same time,based on the requirements of the whole process management of clinical trials,the efficient data integration,database design standardization and terminology consistency,clinical trial data security and subject privacy protection of CTMS and hospital clinical business system(HIS,LIS,RIS,PACS,EMR,etc.)based on hybrid cloud architecture are studied.Finally,the integrated CTMS based on hybrid cloud can be used as a special database for clinical trials to fully guarantee the full process,high efficiency,high quality and standardized operation of clinical trials.Specific work contents include:1.Conducted in-depth research,analysis and design of requirements for the whole process management of clinical trials,analyzed and proposed system functional requirements,data integration requirements,data security requirements and non-functional requirements.Based on the requirement analysis,the design goal of the system is further proposed,and the overall architecture,topological structure,hierarchical structure,data integration mode and data security framework of the system are designed.Based on the overall framework design of the system,functional modules are designed from three levels of project approval and review management,clinical trial operation management and system background management.2.Conduct in-depth research on key technical issues that need to be solved in the design and implementation of the integrated clinical trial management platform based on hybrid cloud,including closed-loop management based on business flow,standardized database construction,medical hybrid cloud platform architecture,efficient integration of medical data and medical data security and privacy protection.3.Design and implement core functional modules for the whole process management of clinical trials,including project management,ethical review,subjects,experimental drugs,finance,quality control and other core functional modules.4.Conducted functional and performance tests on the system,the test results show that the designed and realized functions fully meet the requirements of the whole process management of clinical trials,and the system runs stably and reliably,and meets the requirements of performance indicators.At the same time,the application effect of the system is analyzed.