Oracle CTMS.pdfVIP

Insert Picture Here Siebel Clinical Trial Management System Rachel Yang, M.D., Ph.D. Director, Product Strategy, HSGBU CTMS Definition ? Clinical Trial Management System: ? Customizable Software System …to manage the large amount of data involved with the operation of clinical trials ? Maintains and manages the planning, preparation, performance, and reporting …with emphasis on keeping up- to-date contact information for participants and tracking deadlines and milestones… ? Provides data into a business intelligence system, which acts as a dashboard for trial managers Pervasive CTMS Requirements ? Investigator and Site Management ? Patient Enrollment Visit Tracking ? Visit Reporting and Issues Tracking ? IEC/IRB Approvals ? Project Management ? Budgeting and Financials ? Document Management Tracking ? 2009 Oracle Corporation – Proprietary and Confidential Why Do We Need CTMS? ? Complex logistic needs ? Multi-facets, multi-phasing, spanning multiple organizations and involving multiple stake holders ? Trials are increasingly global in nature ? Variable business processes and operational standards ? Need to implement standardized operating procedures (MA, high growth) ? Long and costly endeavor ? Inefficient process, manual work, long cycle time and cost overrun ? Lack of timely insight and to enable better decision making ? Regulatory liability ? … 开展临床试验时面临的挑战 ? 难以及时掌握试验进程和和状态 ? 事件/日期栏目-无法查看细节 ? 无法及时跟踪试验的所有重要环节 ? 向伦理委员员会 (EC/IRB) 递交文件并获批准 ? 研究期间逾期的各种文件 ? 在执行项目时所遇到到的安全问题 ? 针对研究者和和伦理委员员会的安全信息更新 ? 难以及时获取整项研究中背离、违反协议和和严重不良事件的状况 ? 无法及时了解招募募的情况与延迟的情况、并采取更积极的措施 ? 难以实时监控研究协议中的财务务支付状况 ? 2010 Oracle Corporation – Proprietary and Confidential Clinical Trials Management Process Plan Set Up Conduct Clinical Collate Results Complete Stu