Medidata CTMS

When trial oversight lives in spreadsheets and follow-ups, teams lose critical time and visibility. 

Medidata Clinical Trial Management System (CTMS) brings clinical and operational activity into one connected view, working alongside the systems teams rely on to plan, track, and oversee studies.

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Where Clinical and Operational Work Come Together

Replace fragmented trackers with a single system designed to reduce clicks, surface what matters most, and keep teams informed through automatic notifications. Enter information once and reuse it seamlessly across workflows.

Visit Monitoring
Issue Management
Oversight and Reporting
Document Submission
and Tracking
ICF Review
Study Management
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Why Choose Medidata CTMS

Scalable

Scalable

Reliably support growing portfolios with consistent performance as studies scale.

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Proven Results with Medidata CTMS

Automated Workflows Make a Lean Team More Efficient

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CASE STUDY

Learn how fast-growing pharmaceutical company Enterin implemented Medidata CTMS to enable their resource-constrained team to work more effectively.

"By automating manual workflow and bringing all of our data together, Medidata CTMS has streamlined our entire clinical trial management lifecycle."


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Explore deeper guidance and related materials.

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FAQ

Medidata CTMS is tightly integrated with both Rave EDC and Medidata eTMF to optimize collaboration and streamline data flow. Data is automatically populated from the EDC for dashboards and analysis, and when users upload documents once, the eTMF is automatically updated with the content. Additionally, data auto-populates into monitoring visit reports, which are then automatically filed to the TMF.

Yes. Study start-up activities are embedded directly within Medidata CTMS and Medidata eTMF, allowing teams to track site-specific required milestones and tasks in one place. This creates a closed-loop system for site activation activities and issue management, which helps eliminate the need for multiple status spreadsheets and tracking reports.

The platform offers a modern, configurable site monitoring workspace that provides clinical research associates (CRAs) with in-context data feeds to streamline preparation, execution, and follow-up activities. Issues can be created from anywhere within the workspace, and monitoring reports and letters are automatically filed to the TMF.

Yes. The solution features Medidata CTMS Visual Analytics, which allows users to create intuitive visuals by combining data across studies into a single visualization, report, or dashboard. This provides efficient management of the entire study with data automatically populated from any EDC for forecasts and analysis.

Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.