What is a Clinical Trial Management System (CTMS)?
Clinical trials help establish the safety and effectiveness of drugs or medical devices in patients. A Clinical Trial Management System (CTMS) is any software used to manage end-to-end clinical trial activities, including setup, preparation, conduct, monitoring, and closeout.
Benefits of a CTMS
Improve trial efficiency through standardization, tracking, and data analytics.
1. Increase Productivity
As your organization grows, so does the complexity and number of trials, which entails sophisticated document, financial, and resource management. A CTMS provides user-friendly interfaces and one centralized repository for all study information, which reduces the need for data re-entry. Study teams can link the same information entered once to different milestones, risks, and tasks.
2. Enable Data-Driven Decisions
With customizable and insightful reporting, Clinical Operations can monitor key metrics (such as site enrollment status, patient enrollment, and completed subjects) to develop actionable insights. Furthermore, higher data visibility gives sponsors the real-time trial status, cutting down on avoidable delays in waiting for study team members or the CRO to provide critical information.
3. Enhance Transparency
Many CTMS solutions can integrate with EDC, safety databases, and ePRO. As a web-based platform, a CTMS not only frees itself from physical constraints of storing large amounts of trial data, but also accelerates remote data entry, access, and processing.
4. Improve Compliance
Due to concurrent studies and numerous sites, oversight of all trials is a daunting task. CTMS feature workflow automation, which reduces human error and ensures continued, timely execution of trial processes. By standardizing workflows within the system, organizations can ensure that users consistently follow in-house guidelines, trial protocols, and the latest regulations.
Study Planning & Oversight
- Assess study milestones (ex: first patient in, last patient out) via user-friendly interface.
- Reference operational data of historical trials in a centralized repository.
- Send automatic notifications to CRAs when site visits are almost due.
Popular CTMS Systems
There are numerous CTMS vendors in the life sciences space, all of which generally provide milestone tracking, workflow automation, and visual analytics. Below, we’ve listed some solutions that our clients use:
- Rave CTMS (Medidata, Dassault Systemes): End-to-end cloud-based platform featuring intelligent risk detection and bidirectional information transfer with Rave eTMF.
- Siebel CTMS (Oracle): Trial management suite that improves data quality and risk analysis at both study and portfolio levels; can be integrated with advanced analytics capabilities.
- Trial Interactive CTMS (TransPerfect): Mobile-first 360° platform that offers integrations with TI’s site feasibility, study start-up, eTMF, LMS, content management, and collaboration solutions.
- Vault CTMS (Veeva Systems): Adopted by hundreds of organizations, Vault CTMS can consolidate with other applications in the Vault Clinical Operations Suite: EDC, Study Start Up, Payments, and Veeva Site Connect.
Our Approach to Clinical Trial Management Systems
Business Requirements
CTMS solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if a high degree of...
Budget
CTMS should be viewed as an investment. Licensing, system support, and subscription fees may be continuing costs that should be compared against your department’s budget. Consider how pricing...
Timeline
Consider each vendor’s proposed implementation timeline against the time constraints of your company. If your first study site activation is in two months, narrow consideration down to...
Complexity
Purchasing a CTMS is an investment not only of money, but also of time and effort. Regardless of organization size, it is a challenge to manage clinical trial data (a responsibility...
Compliance
Does the CTMS software meets all requirements imposed by HIPAA, GDPR, and 21 CFR Part 11? Assess the vendor’s agility in releasing new features to support evolving regulations.
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