Medidata CTMS

What Medidata CTMS is

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.