While individual solutions have served to automate or maintain particular application spheres, providing multi-functional systems containing overlapping information and functionality brought big inefficiencies. The area found that eliminating data discrepancies between systems has decreased the information reconciliation activities and assisted to ensure that those responsible for a clinical process always has accurate and up-to-date information.
Usually, a clinical trial management system maintains information to a business intelligence system, which serves as a digital dashboard for trial managers. CTMSs help the professionals to get access to centralized data and thus decrease the number of delayed trials. From this point of view, people usually turn to clinical trials management software in order to get a perfect understanding of the subtleties of this system.
What Is A Clinical Trial Management System?
A clinical trial management system (CTMS) is a special software system utilized to manage clinical trials in healthcare research. This CTMS works as a single, centralized, web-based enterprise instrument to support clinical research findings conducted within or across the three facilities. The main characteristics are the following:
- clinical research management – the system enables management of many spheres of clinical research, involving the next issues: study start-up timelines, tracking and reporting of protocol and accrual information, study financial management and billing compliance;
- billing compliance – the CTMS is suitable for sharing study calendars, centralizing & standardizing billing procedures including sponsor invoicing and subject visit tracking;
- integrations/interfaces – the CTMS facilitates patient information transfer from the healthcare facility to the CTMS and engages other study-related modules to maintain Scientific Review Committee processes.
The issue of CTMS serves as a comprehensive machine, which is responsible for many experts in terms of different spheres of healthcare, using special clinical trials management software.
The Benefits of Clinical Trial Management System
There are many benefits of CTMS. Here, we recommend you to see the following:
- Availability of accurate, up-to-date, study data – having a CTMS solution maintains transparency and unified ability to study data, so the professional team can do their job and make conscious decisions.
- Collaboration – the CTMS is a perfect option for members of a study group to work together, as well as supporting collaboration across teams. They can collaborate on a single issue for the same study, such as any startup, being confident that they are accessing the latest information.
- Efficiency – the CTMS is a specialized productivity instrument that helps your busy study group to plan, track and monitor the processes effectively;
- Oversight – the CTMS ensures transparency to look through the critical issues of your study management, paying attention to study startup, screening & enrollment, document collection.
Each of these features is indispensable, because they all make the formation of the clinical trial data management system.
Choosing the Right Clinical Trial Management System
Here, you can spot some of the common components when reviewing eclinical systems and forming a selection of the necessary clinical trial management system software to maintain your preferences:
- feature set – in case you have concrete feature requirements or study management pain points that are a must-have for the system;
- flexibility & customization – in case the CTMS needs to hold your organizations’ activities and policies in terms of field picklists, custom tracking fields and even custom make planning and tracking views;
- support – is it significant that the study management system is supported by a special desk that maintains clinical studies.
It is necessary to choose the CTMS in the right manner, following special rules and recommendations.
Compliance and Clinical Trial Management System
Here, there are some necessary considerations for Compliance with a CTMS:
- audit trail – the CTMS should make a complete audit trail for all info changes performed in the system, including the person who made the change, when, and the values;
- archival rules – usually, it is required to remove records from the CTMS; although, the CTMS should be archiving data rather than deleting the data;
- electronic signatures – the CTMS should support electronic signatures for records that are relevant to the regulatory requirements of your study.
This is not the whole list of the required compliances and clinical trial management system, however, it contains three necessary components that should be analyzed.
CTMSs are critical for daily management of healthcare procedures. Everything that is significant for general oversight of trials should be maintained in a CTMS. This makes life much easier for trial groups and executive management, and it needs fewer resources. Reporting is one of the principal features of CTMSs. Generating reports through a CTMS is convenient and reports can easily be customized.