What is a CTMS?
A Clinical Trial Management System CTMS is a software system used by Biotech, CRO and Pharmaceutical organizations to manage clinical trials in clinical research. The system maintains and manages planning, provides reportable performance functions, along with participant contact information, financial and contractual data as well as tracking deadlines and milestones.
Examples of CTMS system capabilities (usually delivered within modules):
- Project management at global, country and site level
- Milestones planning and tracking
- Regulatory planning and tracking
- Investigational sites and subject management
- Deviations and issue management
- Study financials and investigator grants and payment management
- Clinical supply management including supply tracking
- Clinical trial performance and reporting
Many modern-day SaaS CTMS solutions are offering solutions with advanced capabilities for managing clinical trials which include:
- Protocol and study documentation management
- Electronic data capture EDC development
- Tracking EDC components and summary details
- Financial system integration
- Clinical supply management: storage and shipment
- Clinical data archiving/warehousing and management
- Data analysis and query resolution
- Clinical learning and training
Benefits of using a CTMS include:
- Improved clinical operations decision making resulting from more efficient trial planning/tracking milestones (better predictability of Site Opening and First Patient In)
- Increased trial investigator selection rates and performance tracking management
- Enhances oversight on site quality issues and deviations
- Excellent data outputs on recruitment progress
- Enhanced relationship management across the clinical trial process (CRO, investigator and sponsor)
- Accurate financial reporting with enhanced ability to manage operations of individual studies and the entire set of clinical programs, by helping management and tracking of CT costs/payments and clinical drug supplies.
- Improved visibility on general study compliance
How to select a CTMS solution
When selecting an CTMS solution, Pharmaceutical, Biotech and CRO organizations should: consider both current and future needs, analyse trends and challenges, understand CTMS capabilities and finally review the various CTMS solution options, weighing up potential benefits of this system against current clinical operations objectives.
Consulting with a professional partner like AgosIT can help you understand these needs enabling you to find the right solution.