RTSM (IRT)

Suvoda RTSM (also referred to as IRT, or Interactive Response Technology) is a randomization and trial supply management system designed for sponsors and CROs running clinical trials. It is built to handle complex protocols across therapeutic areas including oncology, CNS, and rare disease, and covers complexity across operations, geography, and languages. The system uses agentic AI to reduce study startup timelines, with preliminary testing indicating kickoff-to-UAT timelines can be cut by up to 80%, reaching as little as two weeks in some cases.

At its core, Suvoda RTSM manages patient randomization and drug supply to ensure the right drug reaches the right patient at the right time. An embedded AI assistant called Sofia is available throughout the system, allowing users to ask questions, pull reports, check depot inventory, review drug lot releases, and create visualizations through a conversational interface without navigating multiple screens.

Agentic AI and Study Startup

• Multiple AI agents work in parallel to handle distinct phases of the study build, including software configuration, customization, and testing.
• The system is built on Suvoda's patented platform and draws on experience from thousands of previously delivered trials rather than starting each build from scratch.
• Agentic AI also handles change order configuration mid-study, reducing the time required for protocol amendments.
• Permissioned users can make commonly needed modifications and corrections directly in the system after go-live without submitting a change order.
• The modular architecture supports fast launch and adaptation when protocol requirements change.

Trial Logistics Features

• Agentic AI study build and configuration
• Roles, permissions, and blinding management
• Study and site administration
• Cohort, stage, and phase management
• Dynamic cohort and dose management
• Additional and dynamic visit scheduling
• Embedded Sofia AI assistant

Patient Logistics Features

• Subject management
• Adaptive replacement and randomization
• Cross-over and re-treatment support
• Open-label extension
• Dose calculation
• Subject roll-over
• Dose modification and interruption

Drug Logistics Features

• Drug dispensing management
• Drug supply management and forecasting
• Drug accountability, reconciliation, and returns/destruction management
• Temperature excursion management
• Controlled substance management
• Variable drug sourcing
• Central pharmacy support
• Direct-to-patient shipping
• Robust supply strategy management
• Fast access to drug supply data and visualizations via Sofia AI assistant

Reporting and Data Visibility

• Pre-set and ad-hoc reports provide real-time views of subjects, sites, drugs, and depots.
• Reports cover KPIs and trends relevant to day-to-day trial management and planning.
• Sofia can be used to request depot inventory summaries, flag supply risks, or pull cross-site compliance views directly within the interface.
• Real-time visibility is available across the full trial, supporting decision-making grounded in current study data.

User Interface and Experience

• The interface uses minimalist design and intuitive navigation intended for site coordinators, study teams, and home caregivers alike.
• Patient-centric workflows are designed to be consistent whether a user accesses the system daily or infrequently.
• Sofia enables users to complete tasks such as comparing depot inventories or reviewing drug lot releases through conversation, without leaving the current screen.
• Study blinding is maintained within the Sofia AI assistant interactions.

Suvoda RTSM integrates with temperature data loggers, temperature monitoring software, and depot distribution solutions for cold supply chain management. It also supports direct-to-patient shipping for decentralized trials, with tools designed to protect patient privacy and blinding. The system is part of a broader unified clinical trial platform and supports integration within complex technology ecosystems. Suvoda has been named a Leader in the Everest Group RTSM PEAK Matrix.