Clinical trial management system

A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports. Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers.

In the early phases of clinical trials, when the number of patients and tests are small, most managers use an in-house or home-grown program to handle their data. As the amount of data grows, though, organizations increasingly look to replace their systems with more stable, feature-rich software provided by specialized vendors. Each manager has different requirements that a system must satisfy. Some popular requirements include: budgeting, patient management, compliance with government regulations, and compatibility with other data management systems.

Each sponsor has different requirements that their CTMS must satisfy; it would be impossible to create a complete list of CTMS requirements. Despite differences, several requirements are pervasive, including: project management, budgeting and financials, patient management, investigator management, EC/IRB approvals, compliance with U.S. Food and Drug Administration (FDA) regulations, and compatibility with other systems such as data management systems, electronic data capture, and adverse event reporting systems.

See also

• Clinical trial management
• Clinical trial
• Clinical data management system

References

• Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, Hunscher D, Clauw D., Usability comparison of three clinical trial management systems, AMIA Annu Symp Proc. 2005;:921.
• Payne PR, Greaves AW, Kipps TJ., CRC Clinical Trials Management System (CTMS): an integrated information management solution for collaborative clinical research, AMIA Annu Symp Proc. 2003;:967.

External links

• Some clinical trial management systems. at the Open Directory Project
• ObTiMA is an ontology-based clinical trial management system intended to support clinicians in both designing and conducting clinical trials.