Electronic Informed Consent System for Patient-Centric Clinical Trials A clinical research organization needed a modern informed consent solution that could support decentralized and site-based trials while meeting strict regulatory and data protection requirements.
Paper-based consent processes were slow, error-prone, and difficult to manage across multiple sites and countries. Sotex Solutions designed and delivered an electronic informed consent system that enabled fast, secure, and patient-friendly consent collection, fully integrated with clinical trial workflows.
Challenges
- Paper-based consent processes are causing delays and administrative burden
- Limited assurance that participants fully understood study procedures
- Difficulty managing consent versions, languages, and signatures across sites
- Strict requirements for data protection, auditability, and regulatory compliance
- Need to support both digital and paper consent within the same study
Our Solution and Key Features
Sotex Solutions built a patient-facing electronic consent system designed to improve participant understanding while ensuring traceability, security, and compliance.
The solution supported both electronic and paper consent workflows and integrated seamlessly with clinical data and operational systems.
Key capabilities included:
- Web-based, device-independent access using a bring your own device model
- Multimedia consent content, including text, video, and interactive elements
- Integrated questions and questionnaires to support participant understanding
- Hybrid consent workflows supporting electronic and paper-based processes in parallel
- Multilingual consent content with language and version control
- Advanced digital signatures with full traceability and completion certificates
- Real-time integration of consent status with study databases and workflows
- Role-based access controls, encryption in transit and at rest, and full audit trails
- Integrated reporting and dashboards to track consent progress and completeness
The system was designed to reduce friction for participants while giving study teams full visibility and control over the consent process.
Key Achievements
- Consent completion time reduced to minutes through digital workflows
- Improved participant engagement and understanding through interactive content
- Reduced administrative effort for sites through automated tracking and reporting
- Consistent consent management across countries, languages, and trial designs
- Strong compliance posture through audit-ready digital records
Technology Stack
Frontend: Angular
Backend:ASP.NET Core (.NET 10, C#)
Database: Microsoft SQL Server
Cloud Hosting: Azure
Integrations and Frameworks: Document & file storage abstraction (Blob Storage/file system), integration with EDC
Conclusion
The delivered eConsent system modernized the informed consent process by combining patient-centric design with enterprise-grade security and compliance. By supporting hybrid workflows, real-time integration, and clear auditability, the solution enabled faster trial startup, better participant experiences, and reliable regulatory readiness.
CTA
Looking to modernize informed consent for your clinical trials?
Contact Sotex Solutions to learn how we design patient-friendly, compliant consent systems for regulated research environments.
📧 contact@sotexsolutions.com
📞 +381 64 165 7193
