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Medidata CTMS
What Medidata CTMS is
Medidata CTMS is a cloud-based system for planning, tracking, and overseeing clinical and operational trial activity. It supports visit monitoring, issue management, oversight and reporting, document submission and tracking, informed consent form review, and study management. The product supports sponsor-led and CRO-managed models across study phases. Its enrollment forecasting estimates a baseline from historical cohort performance and updates trajectories as trial performance changes. A configurable monitoring workspace gives clinical research associates contextual data feeds for preparation, execution, follow-up, and issue creation; reports and letters can be filed automatically to the TMF. CTMS integrates with Medidata Rave and eTMF. EDC data can feed dashboards and analysis, while uploaded documents and monitoring reports flow to eTMF or TMF. Visual Analytics combines information across studies in visualizations, reports, or dashboards. Medidata lists security certifications, agency certifications, and frameworks, and provides documentation addressing regulations including ICH E6 and 21 CFR Part 11. Pricing is available by contacting a specialist.
Who it suits
It suits teams managing sponsor-led or CRO-managed clinical studies that need connected monitoring, enrollment forecasting, and oversight workflows. Clinical research associates may benefit from its configurable monitoring workspace.
What it does well
- Supports sponsor-led and CRO-managed study models.
- Updates enrollment trajectories with trial performance.
- Integrates with Medidata Rave and eTMF.
- Combines data across studies in Visual Analytics.
What to know first
- Pricing requires contacting a specialist.
- Some compliance materials require an iMedidata account.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Medidata CTMS | Pricing available by contacting a specialist | On request |
As medidata.com lists them, read 4 Oct 2026. The maker's own page has the final word.
Getting started
- Visit the Medidata CTMS website.
- Contact a specialist to explore pricing.
- Use the web platform to access the cloud deployment.
- Ask about enablement and optimization through Medidata Professional Services.
- Use self-paced or instructor-led training to learn the system.
Verdict
Medidata CTMS brings trial management workflows, enrollment forecasting, and analytics together in a cloud system. Prospective customers need to contact a specialist for pricing.
Questions
How much does Medidata CTMS cost?
Pricing is available by contacting a specialist; no price is shown.
What platforms does Medidata CTMS support?
The listed platform is web, and deployment is cloud.
Does it support sponsor-led and CRO-managed studies?
Yes. Medidata says it supports both models across study phases.
What does its enrollment forecasting do?
It estimates baseline enrollment from historical cohort performance and updates trajectories based on real-time trial performance.
Which Medidata products does it integrate with?
CTMS is integrated with Medidata Rave and eTMF. EDC data can populate dashboards and analysis, while documents and monitoring reports can flow to eTMF or TMF.
What compliance documentation does Medidata list?
Documentation addresses ICH E6, 21 CFR Part 11, EU GMP Annex 11, and FDA guidance. Some materials require an iMedidata account.
Facts from Medidata CTMS's own pages
- 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, 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, 4 Oct 2026
- Company
- Medidata is a Dassault Systèmes brand, and its company history says it was founded in June 1999. · medidata.com, 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, 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, 4 Oct 2026
- Founded
- 1999 · medidata.com, 28 Sept 2026
- Headquarters
- New York, New York, United States · medidata.com, 28 Sept 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, 4 Oct 2026
- Pricing
- The CTMS page directs visitors to contact a specialist to explore pricing; it does not show a price. · medidata.com, 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, 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, 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, 4 Oct 2026
- Study models
- Medidata says CTMS supports sponsor-led and CRO-managed models and is used across study phases. · assetlibrary.medidata.com, 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, 4 Oct 2026
Where Medidata CTMS stands on Freedom251
- Clinical Trial Management#5 of 15
- Life Sciences Software#15 of 28
- Research Project Management Software#14 of 25