Sotex designed and delivered a clinical trial management system that unified planning, execution, monitoring, and financial oversight across multi-site studies. The platform replaced disconnected tools with centralized workflows, real-time visibility, and integrated operational and safety data. As a result, study teams improved execution control, reduced manual coordination, gained clearer budget insight, and made faster, better informed decisions throughout the trial lifecycle.
Overview
A clinical research organization needed a centralized operational system to plan, manage, and oversee clinical trials across multiple sites and countries. Trial operations relied on disconnected tools for planning, monitoring, finance, and reporting, limiting visibility and slowing decision-making. Sotex Solutions designed and delivered a CTMS that unified trial operations, enabled real-time oversight, and supported data-driven execution throughout the full study lifecycle.
Challenges
- Trial planning and execution data are scattered across multiple systems
- Limited real-time visibility into enrollment, milestones, and site performance
- Manual coordination of monitoring visits and action items
- Fragmented budget tracking and invoice processing
- Difficulty correlating operational data with clinical and safety signals
Our Solution and Key Features
Sotex Solutions built a clinical trial management system designed to serve as the operational backbone for complex clinical programs.
The solution provides centralized planning, execution, monitoring, and financial oversight while integrating seamlessly with clinical data and documentation workflows.
Key capabilities included:
- Study milestone and enrollment tracking with adjustable timelines
- Centralized management of sites, investigators, and study staff
- Monitoring visit scheduling, tracking, and automated report creation
- Action item logs to assign, track, and resolve operational tasks
- Integrated adverse event and protocol deviation tracking
- Real-time participant progress and recruitment source monitoring
- Comprehensive budget creation, cost tracking, and invoice management
- Automatic linkage of operational documents into the trial master file
- Interactive calendars, timelines, and customizable operational dashboards
The system was designed to give sponsors and operational teams a single, consistent view of trial progress and performance.
Key Achievements
Consolidation of trial planning, monitoring, and financial data into a single system
Reduced operational errors by prepopulating data across workflows
Faster monitoring cycles through automated scheduling and reporting
Improved budget control with real-time cost visibility
Better decision-making through integrated operational and safety insights
Technology Stack
Frontend: Angular
Backend:ASP.NET Core (.NET 10, C#)
Database: Microsoft SQL Server
Cloud Hosting: Azure
Integrations and Frameworks: Keycloak (OIDC / OAuth2) for authentication and authorization, Full audit trail + electronic signatures (21 CFR Part 11 readiness), Grafana, OpenTelemetry
Conclusion
The delivered CTMS provided a unified operational layer for managing complex clinical trials. By centralizing planning, execution, monitoring, and financial oversight, the solution reduced operational friction, increased transparency, and enabled teams to manage studies with greater control, speed, and confidence.
Looking to gain full operational visibility across your clinical trials?
Contact Sotex Solutions to explore how we build clinical trial management systems tailored to large-scale, regulated research environments.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
