Medidata RTSM (Randomization and Trial Supply Management), part of the Medidata Rave Clinical Cloud™, is a configurable solution designed to streamline and provide real-time visibility into study randomization, dosing design, and site/depot supply management. It replaces traditional Interactive Voice Response (IVR) and Interactive Web Response (IWR) systems with a modern, agile, cloud-based technology.
Key Benefits
- Accelerated Timelines: The system is pre-validated and fully configurable, with study builds often completed in 2-3 weeks and User Acceptance Testing (UAT) in less than one day, significantly reducing study start-up time.
- Agile Mid-Study Changes: The Edit Live Design (ELD) feature allows for post-go-live protocol amendments, such as removing a treatment arm or adjusting cohorts, with limited to no downtime, eliminating costly change orders.
- Unified Data Source: Rave RTSM is unified with Medidata Rave EDC (Electronic Data Capture), eliminating the need for separate logs, reducing data reconciliation, and ensuring a single source of truth for all clinical and medical device trial data.
- Support for Complex Trials: It is built to handle the complexities of modern clinical trials, including adaptive designs, oncology trials with repeating visit cycles, and medical device tracking and accountability.
Main Features and Capabilities
- Robust Cohort Management: Powerful features to support adaptive trials, including real-time control over opening/closing cohorts and moving patients between them.
- Direct-to-Patient (DtP) Capabilities: Flexibility to trigger DtP shipments at the site, visit, or patient level, with patients confirming receipt via the myMedidata App.
- Comprehensive Supply Management: Includes buffer and predictive supply schemes that can be altered in real-time, drug pooling across multiple studies, and forecasting capabilities to prevent stockouts.
- Supply Integration Service: Pre-validated, two-way integration with large depot vendors for automated shipment to sites or Direct-to-Patient shipments.
- Unified Electronic Supply Accountability (eSA): Integration with Rave EDC eliminates paper logs and streamlines closeout processes.
- Multi-Dose Vial Tracking: Supports the dispensation of a single item to multiple patients and captures viability information of the remaining doses.
Target Users and Use Cases
Target Users: Clinical Supply Managers, Data Managers, Clinical Operations Managers, Sponsors (Pharmaceutical/Biotech), Contract Research Organizations (CROs), and Site Investigators.
Use Cases:
- Executing complex adaptive clinical trials that require mid-study changes to randomization and supply logistics.
- Managing Direct-to-Patient (DtP) and decentralized clinical trials (DCTs) with integrated patient engagement.
- Conducting medical device trials that require robust device tracking and accountability.
- Streamlining trial supply management and logistics for global, multi-site studies to reduce waste and prevent stockouts.