RTSM

Medrio RTSM (Randomization and Trial Supply Management) is a powerful, configurable clinical trial software solution designed to replace complex systems and spreadsheets with an intuitive, no-code platform. It enables clinical research teams to set up randomization and supply management in hours, seamlessly adapt to mid-study changes, and maintain full oversight of the investigational product journey from manufacturing through to site dispensing.

Medrio RTSM is purpose-built for life science innovators across medical technology, biotechnology and pharmaceuticals, CROs and consultants, and animal health. It supports studies of all sizes and geographies, including multi-center and global clinical trials, making it a versatile solution for any study design or complexity.

Randomization Capabilities

• Supports a wide range of randomization types and complexities, including stratified randomization, adaptive treatment allocation, and multiple cohorts
• Eliminates selection bias through automated randomization algorithms
• Maintains balanced cohorts and confirms participant eligibility
• Supports single- and double-blind study designs
• Handles complex dosing schemas and adaptive or evolving protocol requirements
• Provides full audit trails to ensure treatment allocations follow the study design and randomization schema

Trial Supply Management and Inventory Control

• Builds a coordinated dispensing plan aligned to manufacturing, packaging, labeling, and demand-driven logistics
• Tracks site inventory and study supply levels in real time, including at sites and depots
• Automates expiry date management to reduce waste and avoid stockouts
• Generates automated low shipment notifications and site inventory resupply orders based on predefined thresholds
• Sets temperature controls, including enforced temperature log uploads and excursion notifications
• Supports management of non-serialized products where needed
• Optimizes supply management with automation, reducing waste and aligning with site storage needs

Participant and Dosing Management

• Confirms participant eligibility and maintains balanced cohorts throughout the study
• Distributes dosing instructions and schedules to sites
• Supports kit assignment and treatment allocation in line with protocol requirements

Study Integrity and Protocol Compliance

• Built-in validations and role-based access controls help maintain protocol compliance
• PHI protections and secure tracking safeguard participant data
• Straightforward audit trails support regulatory inspection readiness
• Supports adaptive and complex trial designs with flexible configuration rules and logic

Self-Service and No-Code Configuration

• Configurable solution that does not rely on custom code, enabling rapid study start-up
• Study teams can work closely with Medrio experts to align the system with their study design
• Once trained, customers can build and manage configurations independently for a fully self-service experience
• Mid-study updates can be implemented easily without disrupting ongoing operations

Operational Efficiency and Automation

• Reduces manual processes and increases accuracy in randomization and inventory management
• Automated workflows reduce administrative burden, freeing operations teams to focus on study performance
• Improves site compliance with supply logistics and reduces data reconciliation effort
• Enhances real-time insight into trial status and supports smoother supply flows to help deliver studies on time

Integration with Medrio's Unified Clinical Data Platform

• Fully integrated with Medrio CDMS/EDC for holistic study oversight and data synchronization
• Enables real-time exchange of key data including subject IDs, enrollment status, visit schedules, and supply use
• Part of an integrated suite that also includes eCOA/ePRO, eConsent, Clinical Data Services, and Clinical Trial Project Management

Medrio provides high-touch onboarding, training, and ongoing support for RTSM configuration and study execution, covering randomization scheme setup, supply logic, inventory tracking, and best practices for integration with CDMS/EDC. The platform upholds the highest compliance standards and is scalable for global, multi-center studies across all therapeutic areas and geographies.