Medidata CTMS

Spec sheet

Purpose

Medidata CTMS brings clinical and operational trial activity into one connected, AI-enabled solution for planning, tracking, and overseeing studies.Read 4 Oct 2026 · medidata.com

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.Read 4 Oct 2026 · medidata.com

Security

Medidata states that its security program holds more than twelve security certifications, six agency certifications, and is built on four frameworks.Read 4 Oct 2026 · medidata.com

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.Read 4 Oct 2026 · medidata.com

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.Read 4 Oct 2026 · medidata.com

Headquarters

New York, New York, United StatesRead 28 Sep 2026 · medidata.com

Founded

1999Read 28 Sep 2026 · medidata.com

Company

Medidata is a Dassault Systèmes brand, and its company history says it was founded in June 1999.Read 4 Oct 2026 · medidata.com

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.Read 4 Oct 2026 · assetlibrary.medidata.com

Analytics

Visual Analytics combines data across studies into visualizations, reports, or dashboards, with data automatically populated from EDC for forecasts and analysis.Read 4 Oct 2026 · medidata.com

Core workflows

The system supports visit monitoring, issue management, oversight and reporting, document submission and tracking, informed consent form review, and study management.Read 4 Oct 2026 · assetlibrary.medidata.com

Pricing

The CTMS page directs visitors to contact a specialist to explore pricing; it does not show a price.Read 4 Oct 2026 · medidata.com

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.Read 4 Oct 2026 · assetlibrary.medidata.com

Study models

Medidata says CTMS supports sponsor-led and CRO-managed models and is used across study phases.Read 4 Oct 2026 · assetlibrary.medidata.com

Plans and prices

Every Medidata CTMS plan and price →

Where Specifiction places it

• Clinical Trial Management#4 of 157.0
• Life Sciences Software#15 of 286.9
• Research Project Management Software#16 of 257.0