FGK’s Clinical Trial Management System
Clinical study management systems have become an integral part of the growing range of software solutions for sponsors and CROs. A so-called CTMS is an essential program in the realm of successful management of clinical trials. At FGK Clinical Research, we offer a state-of-the-art CTMS solution provided by Flex Databases. The software is validated & in-licensed by FGK, designed to streamline and enhance every aspect of clinical trial management for biotech, device and pharmaceutical sponsor companies.
Compilation & Compliance
The CTMS is a modular, fully end user managed platform program which allows combining traditional features related to management and oversight of clinical trials, compilation and tracking of relevant study information and documentation. The software is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Benefits of Using FGK’s CTMS:
Realtime Information Access
One of the standout features of the CTMS by Flex Databases is the ability to access realtime information. This is crucial for maintaining the accuracy and timelines of clinical trial data. Realtime data integration ensures that every stakeholder can make informed decisions quickly.
Ensured Oversight
The Subject Tracking & Invoicing Module is designed to track all patients’ data and manage invoicing online. Realtime program updates on patient status and trial progress ensure oversight.
With the Subject Tracking & Invoicing Module, the sponsor can
- Track subject recruitment, enrollment, and participation in real-time
- Monitor subject visit schedules and statuses, ensuring adherence to the study protocol
- Streamline site invoicing by linking subject visits and activities directly to invoicing events, ensuring accurate and timely billing
- Track payments to sites and investigators, ensuring transparency and accountability
Streamlined Reporting and Site Analytics
The system features comprehensive reporting and analytics tools, enabling Sponsors to generate detailed reports on trial progress.
Amongst others, the Investigators & Sites Management Module provides
- organized information on investigators, sites, vendors, therapeutic areas, IRB/LECs, etc.
- easy search capability for feasibility assessments
- overview of document submissions status to various regulatory authorities
All software modules are configurable down to the user level and can be designed to project specific needs. Customizable reports can be created and visualized in charts and diagrams for easy overview of important study information. These tools support data-driven decision-making, helping to optimize trial processes and improve overall efficiency.
Flexible CRA Management
With our CTMS, sponsors can easily manage timelines and get an overview in daily performance. Monitor visits can be planed, scheduled and documented within the CRA Activity Management Module using any type of visit report (PSV, SIV, IMV, COV).
Within the CRA Activity Management Module:
- Monitoring visit planning and scheduling
- Monitoring visits reports, confirmation & follow-up letters can be generated based on study specific templates
- Configurable action Items tracking
- And more!
Let our CTMS support your clinical trial program
At FGK Clinical Research CRO, we are committed to achieving excellence in clinical research. The Flex Databases product is designed to support your study protocol by providing a comprehensive, integrated program for managing important aspects of clinical trials and to support sponsor oversight. The CTMS ensures the highest standards of quality and efficiency and that’s why we offer it to you!
Whether biotech products, pharmaceuticals, or medical devices, our CTMS solution provides the robust infrastructure needed to gain an encompassing overview in any clinical trial.
Let us help you achieve success and excellence in your clinical research endeavors!
Find out more: All of FGK’s eSolutions
For more information on our clinical trial management system contact FGK today.
