CTMS

Medidata CTMS is a clinical trial management system designed to bring clinical and operational activity into one connected view, replacing fragmented spreadsheets and manual follow-ups with a single, streamlined platform. Built for pharmaceutical companies, clinical research teams, and study sponsors of all sizes, it enables teams to plan, track, and oversee studies more effectively while working alongside the systems they already rely on.

Recognized as the industry-leading CTMS solution in Everest Group's 2024 PEAK Matrix® Life Sciences assessment — ranked first among thirteen evaluated products — Medidata CTMS is trusted across a broad range of therapeutic areas and has supported thousands of studies with decades of clinical experience behind it.

Core Capabilities

• Visit Monitoring: A modern, configurable site monitoring workspace gives clinical research associates (CRAs) 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.
• Issue Management: Issues can be raised and tracked directly within the platform, creating a closed-loop system that eliminates the need for separate tracking reports and status spreadsheets.
• Oversight and Reporting: Medidata CTMS Visual Analytics allows users to combine data across multiple studies into a single visualization, report, or dashboard, providing efficient management of the entire study portfolio with data automatically populated from any EDC for forecasts and analysis.
• Document Submission and Tracking: Documents uploaded once are automatically pushed to the eTMF, reducing duplicate data entry and ensuring records remain current across systems.
• ICF Review: Informed consent form review is managed within the platform as part of the unified clinical and operational workflow.
• Study Management: Study start-up activities are embedded directly within Medidata CTMS and Medidata eTMF, enabling teams to track site-specific required milestones and tasks in one place to reduce study start-up delays.

Key Platform Benefits

• Scalable: Reliably supports growing portfolios with consistent performance as studies scale across customers and therapeutic areas.
• Efficient: Automated workflows reduce manual effort, allowing even resource-constrained teams to manage the full clinical trial management lifecycle more effectively. Information is entered once and reused seamlessly across workflows.
• Easy to Adopt: Designed to reduce clicks and surface the most relevant information, with automatic notifications keeping teams informed without requiring manual follow-up.
• White Glove Support: Medidata provides dedicated support alongside a variety of training options for clients and partners, including both self-paced and instructor-led courses through the Medidata Global Education and Training program.

Integrations and Workflow Connectivity

• Tightly integrated with Medidata Rave EDC: data is automatically populated from the EDC into dashboards and analysis views, and auto-populates into monitoring visit reports which are then automatically filed to the TMF.
• Tightly integrated with Medidata eTMF: documents uploaded once are automatically reflected in the eTMF, and monitoring visit reports are filed without additional manual steps.
• Supports data combination across studies through Visual Analytics, compatible with data from any EDC system for forecasting and analysis.

Medidata CTMS is part of the broader Medidata Platform, which encompasses Study, Patient, and Data experiences alongside Professional Services. It is purpose-built to help clinical operations teams eliminate fragmented tracking, accelerate site activation, and maintain real-time visibility across their entire study portfolio.