In recent years, the management of clinical trials has become increasingly complex as the size, geographic diversity, and complexity of trials grows. Managing these highly complex trials requires the study manager to be in control of a wide range of data. A clinical trial management system (CTMS) serves as the central repository for this information.
A CTMS is an excellent tool for organizing the vast array of study management information needed to effectively execute clinical trials. Although CTMS tools do not collate the actual data captured during clinical trials, which may be captured through an EDC system, they ensure that all other supporting clinical development knowledge is maintained in one consolidated electronic system within the organization rather than in the hands of individual team members or solely in a paper-based trial master file.
These systems — and the potential for the increased efficiencies they can provide — have existed for years. There is no such thing as a “new” CTMS. Even in environments where no formal CTMS exists, many of the functions of a CTMS are in place in various ad hoc spreadsheets and paper files. In other environments, a CTMS has been installed, but the data within the system are not considered trustworthy. Few organizations have implemented a CTMS in a manner…