Sotex designed and delivered a configurable electronic data capture system that replaced manual, error prone trial data collection with a structured, validation driven workflow. The platform enabled rapid eCRF design, controlled updates during live studies, and real time data quality checks with full auditability. As a result, study teams reduced queries, accelerated study setup, improved protocol adherence, and gained immediate access to analysis ready clinical datasets across sites.
Overview
A clinical research organization required a modern electronic data capture system to replace fragmented, manual, and error-prone trial data collection processes. Study teams needed a way to design and deploy complex case report forms quickly, while maintaining high data quality, traceability, and regulatory readiness. Sotex Solutions designed and delivered a configurable EDC system that enabled fast study setup, real-time validation, and analysis-ready datasets from the moment data was entered.
Challenges
- Manual data entry leading to frequent errors and high query volumes
- Long setup and validation cycles for eCRFs
- Difficulty adapting data collection forms once trials were live
- Limited visibility into protocol deviations and data quality issues
- Heavy reliance on technical teams for form changes and reporting
Our Solution and Key Features
Sotex Solutions built a flexible electronic data capture system designed for complex clinical trial workflows and regulated environments.
The solution enabled study teams to design and manage structured clinical data collection without programming, while enforcing data quality and compliance at every step.
Key capabilities included:
- Drag and drop form creation supporting eCRFs, SAE reports, protocol deviation logs, and monitoring visit reports, and many other types of reports
- Adaptive data collection allowing controlled form changes during active trials with full traceability
- Real time validation checks applied at the moment of data entry
- Automated data cleaning logic that reduced reconciliation effort across studies
- Centralized protocol deviation tracking with audit ready records
- Advanced digital signatures applied at document, visit, or field level
- Automatic generation and prepopulation of SAE reports based on captured trial data
- Integrated dashboards and role based reporting for operational oversight
The system was designed to ensure that captured data was immediately usable for monitoring, analysis, and downstream systems.
Key Achievements
Up to 67% reduction in manual data queries due to real time validation
Study setup and eCRF deployment reduced from months to weeks
Significant decrease in duplicate data entry and reconciliation work
Improved protocol adherence through centralized deviation tracking
Faster access to analysis ready datasets across sites and studies
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), Document & file storage abstraction (Blob Storage/file system),
Conclusion
The delivered EDC system transformed clinical data collection from a slow, manual process into a controlled, efficient, and scalable digital workflow. By combining flexible configuration with strong data validation and auditability, the solution enabled study teams to improve data quality, reduce operational burden, and accelerate clinical trial execution while remaining ready for regulatory inspection.
Building clinical systems that demand precision, traceability, and speed?
Contact Sotex Solutions to explore how we design and deliver clinical data platforms tailored to complex healthcare environments.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
