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, AI-enabled solution, working alongside the tools teams already rely on to plan, track, and oversee studies.
Where Clinical and Operational Work Come Together
Replace fragmented trackers with a single AI-enabled system designed to reduce clicks, surface what matters, 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
therapeutic areas
clinical experience
Why Choose Medidata CTMS
Efficient
Efficient
Create connected handoffs from feasibility through startup, keeping data, forecasts, workflows, and stakeholders aligned at every step.
Download Fact Sheet
Watch a Fireside Chat with our CTMS Experts
Trial Management Fireside Chat Pt.1
How CTMS of the Past Worked
Trial Management Fireside Chat Pt.2
AI in Design, Planning, and Startup
Trial Management
Fireside Chat Pt.3
Get Started Now with Painless Migration
Trusted by Sponsors and CROs
“In Medidata, we found a CTMS system and partner that can grow with us. We’ve future-proofed our business and are thrilled with our decision.”
“By automating manual workflows and bringing all of our data together, Medidata CTMS has streamlined our entire clinical trial management lifecycle.”
“We appreciate that Medidata CTMS is built on a single platform. It enables us to consolidate data from various sources into one location, ensuring a unified source of truth and a consistent system of record.”
“Medidata CTMS is intuitive and allows for much smoother work for our CRAs across our worldwide studies. It’s almost like our CRAs have done a full 180.”
“We are excited about where Medidata is going with CTMS.”
“Transitioning an ongoing trial eTMF with over 7,000 regulated content items from an external legacy system and developing new in-house capabilities seemed almost impossible until the Medidata Professional Services team joined our journey. Their expertise in managing the project and upskilling our team ensured a seamless transition, and their dedication to addressing our specific needs made the process highly efficient.”
“We have been working with Medidata since 2019 because of their superior Medidata eTMF solution and outstanding professional services, training, and post-go-live support. We highly recommend Medidata if you are evaluating eTMF solutions and related services.”
INDUSTRY RECOGNITION
Everest Group names Medidata CTMS the leading industry solution.Medidata CTMS was recognized as the leader among 13 products in Everest Group's 2024 PEAK Matrix® Life Sciences Clinical Trial Management System (CTMS) Products.
Medidata CTMS was recognized as the industry leader in Everest Group's 2024 PEAK Matrix® Life Sciences Clinical Trial Management System (CTMS) Products.
Featured Resource
Automated Workflows Make a Lean Team More Efficient
Learn how fast-growing pharmaceutical company Enterin implemented Medidata CTMS to enable their resource-constrained team to work more effectively.
Download Case Study
FAQ
How does Medidata CTMS integrate with Rave and eTMF?
Medidata CTMS is tightly integrated with both Rave 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.
Can Medidata CTMS help reduce study start-up delays?
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.
What specific tools does the platform provide for site monitoring?
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.
Does Medidata CTMS offer analytics for oversight across multiple studies?
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.
Does Medidata offer training for its clients and partners?
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.