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Medidata CTMS
New York, New York, United States
What it is
Medidata CTMS is a cloud clinical trial management system for planning, tracking, and overseeing study activity. It brings visit monitoring, issue management, oversight, reporting, document submission and tracking, informed consent review, and study management into one AI-enabled solution. The system supports sponsor-led and CRO-managed studies across study phases. Its forecasting uses historical cohort performance for baseline enrollment estimates and updates trajectories as real-time trial performance changes. A configurable monitoring workspace gives clinical research associates contextual data for preparation, execution, follow-up, and issue creation, with automatic filing of reports and letters to the TMF. CTMS integrates with Medidata Rave and eTMF; EDC data can populate dashboards and analysis, while documents and monitoring reports can flow to eTMF or TMF. Visual Analytics combines study data into visualizations, reports, and dashboards. Medidata lists more than twelve security certifications, six agency certifications, and four frameworks, plus documentation addressing ICH E6, 21 CFR Part 11, EU GMP Annex 11, and FDA guidance.
For and against
For
- Supports sponsor-led and CRO-managed study models
- Forecasts enrollment from historical and live performance
- Provides configurable monitoring workflows for clinical associates
- Integrates with Medidata Rave and eTMF
- Combines cross-study data in Visual Analytics
Against
- Pricing requires contacting a specialist
- Some compliance materials require an iMedidata account
- Cloud deployment is the listed option
The verdict
Medidata CTMS connects trial oversight, monitoring, forecasting, documents, and analytics in a cloud system. Its integrations and compliance materials support structured clinical operations, with pricing handled by consultation.
Who it suits
It is designed for sponsors, CROs, and clinical research teams managing studies across phases. Teams needing monitoring, enrollment forecasting, document workflows, and cross-study analytics may find its connected approach suitable.
Plans and prices
Medidata CTMS
Pricing available by contacting a specialist
Read 4 Oct 2026 · medidata.com
On the record
- AI forecasting
- The fact sheet says the product forecasts baseline enrollment from historical cohort performance and updates enrollment trajectories based on real-time trial performance.assetlibrary.medidata.com · read 4 Oct 2026
- Analytics
- Visual Analytics combines data across studies into visualizations, reports, or dashboards, with data automatically populated from EDC for forecasts and analysis.medidata.com · read 4 Oct 2026
- Company
- Medidata is a Dassault Systèmes brand, and its company history says it was founded in June 1999.medidata.com · read 4 Oct 2026
- Compliance
- Medidata lists documentation addressing regulations including ICH E6, 21 CFR Part 11, EU GMP Annex 11, and FDA guidance, with some materials requiring an iMedidata account.medidata.com · read 4 Oct 2026
- Core workflows
- The system supports visit monitoring, issue management, oversight and reporting, document submission and tracking, informed consent form review, and study management.assetlibrary.medidata.com · read 4 Oct 2026
- Integrations
- CTMS is integrated with Medidata Rave and eTMF; EDC data can populate dashboards and analysis, while uploaded documents and monitoring reports flow to the eTMF or TMF.medidata.com · read 4 Oct 2026
- Pricing
- The CTMS page directs visitors to contact a specialist to explore pricing; it does not show a price.medidata.com · read 4 Oct 2026
- Purpose
- Medidata CTMS brings clinical and operational trial activity into one connected, AI-enabled solution for planning, tracking, and overseeing studies.medidata.com · read 4 Oct 2026
- Security
- Medidata states that its security program holds more than twelve security certifications, six agency certifications, and is built on four frameworks.medidata.com · read 4 Oct 2026
- Site monitoring
- Its configurable monitoring workspace gives clinical research associates in-context data feeds and supports preparation, execution, follow-up, issue creation, and automatic filing of reports and letters to the TMF.assetlibrary.medidata.com · read 4 Oct 2026
- Study models
- Medidata says CTMS supports sponsor-led and CRO-managed models and is used across study phases.assetlibrary.medidata.com · read 4 Oct 2026
- Support
- Medidata Professional Services provides enablement beyond implementation to help teams adopt and optimize CTMS, and the company offers self-paced and instructor-led training.medidata.com · read 4 Oct 2026
