Sotex designed and delivered an electronic source data system that enabled direct clinical data capture at the point of care with full traceability. The platform replaced paper-based workflows with real-time, validated data entry and automatic transfer to downstream clinical systems. As a result, study teams reduced transcription errors, lowered verification effort, supported remote monitoring, and gained faster access to accurate, analysis ready data across decentralized trials.
Overview
A clinical research organization needed a way to capture clinical data directly at the source while eliminating transcription errors, reconciliation effort, and on-site verification overhead. Paper-based source documents and delayed data entry into downstream systems slowed trials and increased operational risk. Sotex Solutions designed and delivered an electronic source data system that enabled contemporaneous data capture, direct transfer to clinical databases, and true remote monitoring.
Challenges
- Manual transcription from paper source documents to electronic systems
- Data discrepancies between source, clinical databases, and health records
- High cost and effort associated with source data verification
- Limited ability to support remote monitoring and decentralized workflows
- Difficulty integrating data from devices, laboratories, and hospital systems
Our Solution and Key Features
Sotex Solutions built an electronic source data platform designed to serve as the single point of truth for clinical data capture.
The solution enabled data to be entered once at the source and automatically transferred to downstream clinical systems while preserving traceability and auditability.
Key capabilities included:
- Direct electronic source data capture replacing paper-based workflows
- Automatic mapping and transfer of source data to clinical databases and case report forms
- Integration with electronic health records and hospital information systems
- Real-time ingestion of data from wearables, laboratory systems, and medical devices
- Standards-based data mapping supporting interoperability across systems
- Offline data capture with secure synchronization when connectivity is restored
- Role-based access controls and configurable permissions for sites and monitors
- Built-in validation rules applied directly at the source
- Real-time data access and reporting from the moment of entry
- Comprehensive audit trails covering all source data, changes, and transfers
The system was designed to fully support remote monitoring while maintaining data integrity and regulatory readiness.
Key Achievements
Increased data accuracy by eliminating duplicate entry and transcription errors
Significant reduction in source data verification effort through direct data transfer
Faster availability of data for monitoring, review, and analysis
Reduced operational costs by enabling remote monitoring and decentralized trials
Improved consistency between source data and clinical databases
Technology Stack
Frontend: Angular
Backend: ASP.NET Core (.NET 10, C#)
Database: Microsoft SQL Server, MongoDB
Cloud Hosting: Azure and on-premise deployment supported
Integrations and Frameworks: Keycloak (OIDC / OAuth2) for authentication and authorization, Source data capture and source-to-EDC traceability, Integration with EDC, OpenTelemetry for logs, metrics, and traces, Grafana for monitoring, dashboards, and operational visibility
Conclusion
The delivered eSource system transformed clinical data capture into a direct, traceable, and efficient digital process. By eliminating manual transcription and enabling real-time data flow from source to database, the solution reduced operational burden, strengthened data integrity, and supported modern remote and decentralized clinical trial models.
Looking to eliminate transcription errors and enable a true source for database workflows?
Contact Sotex Solutions to learn how we design and build electronic source data systems for regulated clinical research.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
