Sotex built an electronic clinical outcome assessment system that enabled real-time, standardized capture of patient, clinician, and device-sourced outcomes. The platform replaced paper workflows with immediate validation, live analytics, and full auditability. As a result, trial teams improved data quality, reduced operational effort, and gained faster, more reliable insights to support timely clinical decisions.
Overview
A clinical research organization required a robust system to capture and analyze clinical outcome data from multiple sources while maintaining consistency, accuracy, and regulatory readiness: traditional paper-based assessments and fragmented digital tools limited data quality and delayed analysis. Sotex Solutions designed and delivered an electronic clinical outcome assessment system that enabled real time data capture, standardized outcome measurement, and immediate availability of insights across clinical trials.
Challenges
- Delayed availability of outcome data due to paper based or manual processes
- Inconsistent assessment formats across sites and assessors
- Difficulty handling diverse data types such as questionnaires, biomarkers, and time series data
- Limited visibility into data quality and completeness during trial execution
- High operational overhead for managing assessments and follow ups
Our Solution and Key Features
Sotex Solutions built an electronic clinical outcome assessment system designed to support complex data collection scenarios and real time analysis.
The solution unified outcome data from patients, clinicians, observers, and connected devices while enforcing standardization and traceability.
Key capabilities included:
- Support for structured and unstructured clinical assessment data
- Flexible questionnaire and survey configuration, including adaptive logic
- Integration of biomarker data and time series inputs from wearable and sensor devices
- Immediate validation checks at the point of data entry
- Real-time data access, analytics, and graphical reporting
- Automated alerts and reminders to ensure timely assessment completion
- Standardized data formats applied consistently across studies to support analysis and pooling
- Secure, device-independent access using a bring your own device model
- Role-based access controls, encryption, and comprehensive audit trails
The system was designed to accelerate decision-making while maintaining high data quality in regulated research environments.
Key Achievements
Faster access to outcome data through real-time digital capture
Reduced data entry errors via immediate validation and standardized formats
Improved consistency of assessments across sites and trial designs
Lower operational costs by eliminating paper workflows and device provisioning
Enhanced trial insights through integrated analytics and reporting
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), Grafana, OpentTelemetry
Conclusion
The delivered eCOA system enabled reliable, scalable, and insight-driven outcome assessment across clinical trials. By combining flexible data capture with real-time analytics and strong governance, the solution supported accurate outcome measurement, faster decision making, and improved trial execution.
Looking to improve outcome assessment and real-time insights in your clinical trials?
Contact Sotex Solutions to learn how we design and build clinical outcome assessment systems for regulated healthcare research.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
