A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries and clinical research institutions 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 and recruitment, 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.
In addition to pharmaceutical and biotechnology industries, CTMSs are also widely used at the sites where clinical research is conducted such as research hospitals, physician practices, academic medical centers and cancer centers.
While pharmaceutical companies that sponsor clinical trials may provide a CTMS to the sites that participate on their trials, sites can also benefit from having their own CTMS to support their day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators, providing a centralized place to house all trial-related information, and making clinical data management more efficient by equipping staff, including biostatisticians and database administrators, with the time-saving tools necessary to optimize productivity.
CTMS can take many forms. Some systems are cloud based and are delivered in a software as a service (SaaS) modality, while others require dedicated servers.
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