RTSM

The RTSM system is designed to deliver powerful randomization methods and manage trial supplies effectively. It supports a range of randomization strategies, from simple to complex, fully integrated with inventory management. This ensures investigational products are randomized, distributed, and managed efficiently.

Key features include automated patient randomization, which integrates seamlessly with Marvin EDC, allowing for streamlined processes without the need to log into multiple systems. The system supports various study types, including open label, double blind, and triple blinded studies.

Users can upload a Master Randomization List (MRL) to manage subject randomization and treatment arms across multiple sites, utilizing block and stratified randomization techniques. Kit Code List management is also supported, allowing for centralized inventory management and kit allocation.

The supply management component offers comprehensive schemes, including buffer and predictive models, with the flexibility to adjust plans in real-time. This feature helps optimize inventory through pooling and supports adaptive trials with robust cohort management, enabling mid-study changes with minimal downtime.

Benefits

• Remote randomization capabilities reduce overall costs.
• Rapid and flexible implementation.
• End-to-end supply chain management.
• Real-time access to randomization and supply data.
• Data integration and customized reporting.
• Readiness for risk-based monitoring (RBM).
• Support for various delivery methods, including direct-to-patient and site-to-patient solutions.

The RTSM system is a comprehensive solution for managing complex clinical trial requirements, ensuring efficient randomization and supply management throughout the study lifecycle.