Medidata CTMS

C tier on Research Project Management SoftwareScore 6.1 · #13 of 25

Android app: Not listed
Free plan: No
Runs on: Web

Summary

Medidata CTMS is a cloud solution for planning, tracking, and overseeing clinical and operational trial activity. Its workflows cover visit monitoring, issue management, oversight and reporting, document submission and tracking, informed consent form review, and study management. The system supports sponsor-led and CRO-managed studies across study phases. For enrollment planning, it estimates a baseline from historical cohort performance and revises trajectories as current trial performance changes. A configurable monitoring workspace gives clinical research associates contextual data for preparing, conducting, and following up on monitoring, creating issues, and filing reports and letters to the TMF. CTMS connects with Medidata Rave and eTMF: EDC data can populate dashboards and analysis, while uploaded documents and monitoring reports can flow to eTMF or TMF. Visual Analytics combines information across studies into visualizations, reports, and dashboards. Medidata lists security certifications and compliance documentation covering regulations such as ICH E6 and 21 CFR Part 11. Pricing is available by contacting a specialist; no price is listed.

Who it is for

It suits clinical research teams managing sponsor-led or CRO-managed studies that need trial workflows, monitoring, enrollment forecasts, and cross-study analytics in one system.

What is good

Supports sponsor-led and CRO-managed study models.
Forecasts enrollment using cohort history and trial performance.
Monitoring workflows include issue creation and follow-up.
Integrates with Medidata Rave and eTMF.
Offers self-paced and instructor-led training.

What to know first

Pricing requires contacting a specialist.
The platform listing is web-only.
Some compliance materials require an iMedidata account.

Verdict

Medidata CTMS brings trial management, monitoring, forecasting, and analytics workflows together, with integrations to Medidata Rave and eTMF. Teams must contact a specialist for pricing, and some compliance materials require an account.

Medidata CTMS plans and pricing

All plans

Medidata CTMS Not published Pricing available by contacting a specialist medidata.com · 4 Oct 2026

Compared on research project management software

Milestone tracking: Yesmedidata.com
Deployment options: cloudmedidata.com

Facts

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
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
Study models: Medidata says CTMS supports sponsor-led and CRO-managed models and is used across study phases.assetlibrary.medidata.com · 4 Oct 2026
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
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
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
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
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
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
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
Pricing: The CTMS page directs visitors to contact a specialist to explore pricing; it does not show a price.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