Sotex designed and delivered an electronic trial master file system that centralized trial documentation and ensured continuous inspection readiness across studies and countries. The platform replaced fragmented repositories with structured eTMF models, real-time completeness tracking, and strict access control. As a result, study teams reduced filing errors, accelerated trial setup, lowered compliance risk, and maintained clear audit ready documentation throughout the trial lifecycle.
Overview
A clinical research organization required a centralized and inspection-ready system to manage trial documentation across multiple studies, countries, and sites. Existing document handling relied on fragmented repositories and manual oversight, making it difficult to ensure completeness, traceability, and regulatory compliance. Sotex Solutions designed and delivered a configurable eTMF system that enabled structured document management, real-time oversight, and continuous inspection readiness throughout the trial lifecycle.
Challenges
- Fragmented trial documentation spread across systems and teams
- High risk of missing, outdated, or incorrectly filed documents
- Manual tracking of document completeness and approval status
- Complex access control requirements across sponsors, CROs, and sites
- Time-consuming trial setup and repeated configuration for new studies
Our Solution and Key Features
Sotex Solutions built a flexible electronic trial master file system designed to support regulated clinical documentation workflows at scale.
The solution enabled teams to capture, store, approve, and share trial documentation while maintaining full transparency, traceability, and role-based access.
Key capabilities included:
- Configurable eTMF structures based on established reference models, with flexibility to adapt to sponsor or study-specific requirements
- Reusable eTMF indices, roles, and permissions to accelerate setup of new trials
- Pre-created placeholders to guide users and reduce document filing errors
- Automatic document indexing, categorization, and tagging
- Granular access control based on role, organization, country, and site
- Automated version control with full audit trails at the document and placeholder level
- Integrated review, approval, and discrepancy resolution workflows
- Real-time graphical reports highlighting document completeness, quality, and readiness
- Human-readable audit trail exports supporting inspections and reviews
The system was designed to support multiple concurrent trials within a single instance while maintaining clear separation of access and responsibilities.
Key Achievements
Trial setup accelerated by three to five times through the reuse of structures and permissions
Reduced training time by applying consistent roles and document structures across studies
Improved inspection readiness through continuous real-time completeness tracking
Fewer filing errors due to structured placeholders and automated indexing
Lower operational overhead by running multiple trials on a single platform instance
Technology Stack
Frontend: Angular
Backend: ASP.NET Core (.NET 10, C#)
Database: SQL Server
Cloud Hosting: Azure
Integrations and Frameworks: Keycloak (OIDC / OAuth2) for authentication and authorization, Role-based and permission-based access control, Full audit trail, and electronic signatures (21 CFR Part 11 compliant), Integration with EDC and CTMS modules, OpenTelemetry for logs, metrics, and traces, and Grafana for monitoring, dashboards, and system observability. Document & file storage abstraction (Blob Storage/file system).
Conclusion
The delivered eTMF system transformed trial document management into a structured, transparent, and inspection-ready digital process. By combining flexible configuration with strict access control and real-time oversight, the solution reduced compliance risk, accelerated trial startup, and gave clinical teams confidence that documentation was complete and audit-ready at all times.
Need inspection-ready document management for complex clinical trials?
Contact Sotex Solutions to learn how we design and deliver compliant documentation systems tailored to regulated healthcare environments.
📧 contact@sotexsolutions.com
📞 +381 64 165 7193
