Sotex designed and delivered an electronic patient-reported outcomes system that enabled direct, real-time data capture from participants using their own devices. The platform replaced paper and site-mediated workflows with automated questionnaires, reminders, and immediate validation. As a result, study teams improved data quality, increased patient compliance, reduced operational effort, and gained faster access to reliable outcome data across regulated clinical trials.
Overview
A clinical research organization required a reliable way to collect patient-reported outcomes directly from participants while maintaining data quality, compliance, and operational oversight. Traditional paper-based and site-mediated reporting introduced delays, transcription errors, and inconsistent data. Sotex Solutions designed and delivered an electronic patient-reported outcomes system that enabled real-time data capture, improved participant engagement, and seamless integration with clinical trial workflows.
Challenges
- Manual transcription of patient-reported data leads to errors and delays
- Limited visibility into patient compliance and questionnaire completion
- High administrative overhead for distributing and tracking questionnaires
- Need to support diverse questionnaire types, languages, and schedules
- Strict requirements for data security, auditability, and regulatory compliance
Our Solution and Key Features
Sotex Solutions built a patient-centric ePRO system designed to collect high-quality outcome data directly from participants using their own devices.
The solution supported flexible questionnaire design, automated distribution, and real-time oversight while integrating tightly with clinical and operational systems.
Key capabilities included:
- Web and mobile-based access using a bring your own device model
- Programming free creation of any ePRO questionnaire, regardless of length or complexity
- Support for diverse question types, scales, and formats
- Scheduled and trigger-based questionnaire distribution linked to study events
- Automated alerts and reminders for incomplete or overdue questionnaires
- Real-time data validation and consistency checks at entry
- Immediate integration of ePRO data with the study database and operational systems
- Multilingual support with language selection managed per participant
- Role-based access controls, encryption in transit and at rest, and full audit trails
- Integrated graphical reports providing real-time visibility into data quality and compliance
The system was designed to reduce the burden on both participants and study teams while improving data accuracy and timeliness.
Key Achievements
Reduced transcription errors through direct patient data capture
Improved participant compliance via automated reminders and scheduling
Faster availability of outcome data for monitoring and decision making
Lower operational costs through the elimination of device provisioning and manual handling
Higher data quality through real-time validation and consistency checks
Technology Stack
Frontend: Angular
Backend: ASP.NET Core (.NET 10, C#)
Database: SQL Server
Cloud Hosting: Azure
Integrations and Frameworks: Scheduling & reminders (configurable windows, compliance tracking, missed-visit handling), Integration with EDC and CTMS, OpenTelemetry for logs, metrics, and traces, Grafana for monitoring, dashboards, and operational visibility
Conclusion
The delivered ePRO system enabled a more patient-centric approach to outcome data collection while strengthening data quality, security, and operational efficiency. By combining flexible questionnaire design with real-time integration and oversight, the solution supported reliable, scalable collection of patient-reported outcomes in regulated clinical trials.
Looking to improve patient engagement and data quality in your clinical trials?
Contact Sotex Solutions to learn how we design and build patient-reported outcome systems for regulated research environments.
📧 bd@sotexsolutions.com
📞 +381 64 165 7193
