Sotex designed and delivered an integrated randomization and trial supply management system that unified participant allocation and investigational product logistics across global trials. The platform automated randomization, enforced blinding, and provided real time inventory visibility within clinical workflows. As a result, study teams reduced allocation errors, optimized supply usage, prevented stock issues, and executed complex multi site trials with greater control and compliance.
Overview
A clinical research organization required a centralized system to manage participant randomization and investigational product supply across multiple sites and countries. Existing processes relied on disconnected tools and manual coordination, increasing the risk of allocation errors, stock shortages, and protocol deviations. Sotex Solutions designed and delivered an integrated RTSM system that enabled real-time randomization, controlled blinding, and end-to-end trial supply management directly within clinical workflows.
Challenges
- Manual or semi-manual randomization processes are prone to human error
- Limited visibility into investigational product inventory across sites and depots
- Complex blinding requirements with strict access controls
- Difficulty managing expirations, temperature excursions, and quarantined supplies
- Delays caused by low stock situations and inefficient resupply coordination
Our Solution and Key Features
Sotex Solutions built a rules-driven randomization and trial supply management system tightly integrated with clinical data capture workflows.
The solution enabled investigators to randomize participants and allocate treatment directly during clinical visits, while giving operational teams full real-time oversight of inventory and logistics.
Key capabilities included:
- Centralized randomization engine supporting block, stratified, and adaptive randomization schemes
- Automatic treatment allocation presented directly within clinical data entry workflows
- Real-time randomization history with full audit trails
- Secure blinding mechanisms ensuring only authorized roles can access unblinded data
- Emergency unblinding workflows with controlled permissions and traceability
- Real-time tracking of investigational product status, including available, quarantined, missing, or damaged supplies
- Automated low stock alerts and reorder triggers based on predefined thresholds
- Expiration date and temperature monitoring with enforced allocation rules
- Tracking of product dispensation and return with full accountability logs
- Integrated reporting and data export for operational and regulatory needs
The system was designed to support global trials with complex logistics while maintaining strict protocol adherence and compliance.
Key Achievements
- Significant reduction in randomization and allocation errors through automation
- Elimination of manual reconciliation between randomization and clinical data systems
- Improved inventory utilization by prioritizing kits nearing expiration
- Reduced investigational product wastage and unnecessary shipments
- Faster trial execution through real-time visibility and automated supply workflows
Technology Stack
Frontend: Angular
Backend: Microsoft .NET (ASP.NET Core)
Database: SQL Server
Cloud Hosting: Microsoft Azure
Integrations and Frameworks: Keycloak (OIDC / OAuth2) for authentication and authorization,
OpenTelemetry for logs, metrics, and traces
Grafana for monitoring, dashboards, and operational visibility
API-first architecture for integration with EDC, CTMS, IWRS, and external vendors
Conclusion
The RTSM system delivered by Sotex Solutions transformed randomization and trial supply management into a controlled, transparent, and highly efficient digital process. By combining advanced randomization logic with real-time inventory oversight and strict blinding controls, the solution reduced operational risk, optimized resource usage, and supported reliable execution of complex multi-site clinical trials.
Managing complex randomization and trial supply workflows?
Contact Sotex Solutions to learn how we design and build clinical trial systems that balance precision, compliance, and operational efficiency.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
