oomnia RTSM

oomnia RTSM is a randomization and trial supply management module developed by Wemedoo, built directly into the oomnia unified clinical trial platform. It automates treatment allocation within the eCRF, tracks investigational product (IMP) inventory across sites in real time, and is designed to prevent supply shortages without requiring a separate IRT system or external integration.

The platform is intended for clinical operations teams managing trials of varying complexity, from standard parallel-group studies to adaptive, crossover, dose-escalation, and multi-arm designs. It holds ISO 27001, SOC 2, FDA 21 CFR Part 11, GDPR, and HIPAA compliance certifications, and is hosted under Swiss data privacy standards.

Core Randomization Capabilities

• Randomization is performed directly within the eCRF with a single click, simultaneously verifying IMP availability, assigning the correct kit, and allocating the study arm.
• Supports standard algorithms including simple randomization, block randomization, stratified randomization, minimization, and dynamic allocation.
• Handles both blinded and open-label trial designs.
• Supports object-level randomization, allowing randomization of devices, images, samples, or other objects beyond trial participants.
• Configurable randomization methods (stratified, block, dynamic) with the ability to upload randomization lists and tailor the setup to specific trial designs.
• Non-standard randomization approaches can be developed and validated on request.

Trial Supply Management

• Real-time tracking of IMP inventory across all clinical trial sites.
• Automated alerts and notifications when inventory drops below defined thresholds or nears expiry.
• Dynamic expiry protection: study staff are automatically notified about soon-to-expire IMPs, and delivery of expired investigational products is blocked.
• Automated kit assignment eliminates manual checks and ensures accurate treatment assignments.
• Drug supply initialization for new sites is handled automatically.
• Shipment tracking supports continuity and prevents supply disruptions.

EDC and RTSM Integration

• oomnia RTSM operates within a single unified database shared with the EDC, eliminating the need for reconciliation between separate systems.
• Direct communication between EDC and RTSM removes manual data transfer steps and reduces the risk of errors.
• Real-time visibility across EDC and RTSM data supports oversight of clinical operations and helps prevent protocol deviations.
• No separate IRT system or complex integration is required.

Compliance and Data Management

• Supports full protocol adherence tracking and compliance monitoring.
• Provides real-time reporting on protocol deviations by country, site, and participant.
• Automated role-based email alerts notify designated personnel for timely review and approval of deviations.
• Data standardization is maintained across the unified platform.
• Versatile data export options support analysis and stakeholder collaboration.

Case Study Outcomes

• Ophthalmology Medical Device and Drug Study: Managed a study with over 5,000 CRF questions; dynamic eCRF features reduced manual queries by 66%. Design, implementation, UAT, and site training were completed in 9 weeks, and database lock was achieved within 2 weeks of the last patient visit.
• Medical Device Real-World Evidence Study: Integrated retrospective data collection and prospective ePRO arms using oomnia EDC, eConsent, and ePRO, with dynamic eCRF automation and real-time consent tracking.
• Phase IV Pediatric Study: Implemented a protocol deviation log with real-time reporting, automated role-based alerts, and dynamic eCRF behaviors that reduced redundant data entry and time required to track and resolve deviations.

Reported Performance Metrics

• Up to 73% cost reduction attributed to reduced manual labor and automated processes, based on client reports.
• Over 50% operational efficiency improvement based on client feedback on time efficiency gains.
• 100% data standardization across the unified platform.

oomnia RTSM is part of the broader oomnia SaaS ecosystem, which includes EDC, eTMF, CTMS, eSource, ePRO, eCOA, and eConsent modules, all operating on a single instance and supporting multiple trials simultaneously. Teams can select the modules relevant to their workflow and configure the system accordingly.