A Clinical Trial Management System is a systematic organized approach to managing your global clinical trials throughout its life cycle; Of particular importance are the following activities that a CTMS can help manage;
• Track IRB/EC Approvals
• Streamline work flow
• Track GCP training
• Track subject/patient enrollment per investigative site
• Manage/track clinical trial initiation (first patient in )
• Manage/track clinical trial close out (last patient out)
• Track timeline (milestones)
• Manages the planning, ongoing budget performance and reporting of a clinical trial
• Track clinical documents such as updates to Investigator Brochure, clinical protocol amendments IND annual safety updates and study procedure manuals
• Help in the management of regulatory compliance
• Track Investigator contracts
• Track external vendor contracts including the number of change orders
A Clinical Trial Management System is also a global communication tool which allows cross functional teams and teams in various locations to be in the loop of up to date information. A CTMS utilized effectively can streamline clinical project management activities including the frequency of clinical project meetings. It also allows an organization to proactively problem solve.
Often times an organization will start off with a “home grown” Clinical Trial Management System and then transition to a specialized vendor. However, I would not recommend such an approach. In early stage of development when patient numbers and investigational sites are small you probably will not need a system with all the “bells & whistles” however, as you move into late stage development with a large number of patients, investigational sites and data, a customized feature rich system with all “bells & whistles” will probably be essential. Why not start small with a vendor and build on as necessary. There are many vendors out there that can assist with startup needs, customize reports and thus, build to your specifications.
As we all are aware, the cost of getting a drug to market is staggering and utilizing tools to optimize the drug development process is good leadership sense.