New eTMF module integrates with Enlighten Clinical Solutions’ platform to support inspection-ready clinical trial documentation and execution.
ATLANTA, GA, UNITED STATES, January 13, 2026 /EINPresswire.com/ — Enlighten Clinical Solutions today announced the official release of its integrated electronic Trial Master File (eTMF) module, expanding the company’s clinical trial platform to further support compliant, inspection-ready trial execution within a modern, unified system.
The eTMF module is part of Enlighten Clinical Solutions’ integrated clinical trial platform, designed to support inspection-ready trial execution by bringing trial documentation management and Electronic Data Capture (EDC) into a single, cohesive system—without the fragmentation common to legacy solutions. “Trial teams are often forced to manage essential documentation in systems that sit outside their core study workflows,” said Jim Harris, Founder & CEO of Enlighten Clinical Solutions. “Our integrated eTMF was built to make inspection readiness part of normal study operations, rather than a separate process teams have to manage in parallel.”
Designed for Real-World Clinical Operations
Rather than treating eTMF as a standalone repository, Enlighten Clinical designed the module to align with how clinical trials are actually run. Documentation workflows are structured to support site teams, monitors, sponsors, and CROs—reducing operational friction while maintaining regulatory rigor.
Key design principles behind the eTMF module include:
• Integrated platform workflows that reduce duplicate work and manual coordination
• Modern, responsive performance designed to remain usable as document volumes scale
• Clear visibility into document status, completeness, and oversight activities
• Embedded compliance practices that help teams maintain inspection readiness as part of normal study operations
The eTMF module reflects Enlighten Clinical’s broader platform philosophy: software built without legacy architectural constraints and designed to evolve alongside regulatory and operational requirements.
Compliance and Transparency
The eTMF module operates within the company’s broader security and compliance framework, which includes a SOC 2 Type II–audited control environment with ongoing monitoring and review, as well as HIPAA- and GDPR-aligned controls. Compliance and security practices are embedded into daily operations and supported by a public Trust Center, providing transparency into the company’s control environment.
Advancing a Unified Clinical Trial Platform
The release of the integrated eTMF module represents an important step in Enlighten Clinical’s long-term platform vision of supporting the full clinical trial lifecycle within a cohesive system. By reducing system fragmentation and aligning documentation and data workflows within a single platform, the company aims to improve operational clarity and execution across the study lifecycle.
The integrated eTMF module is available immediately to Enlighten Clinical Solutions customers.
For more information, visit www.enlightenclinical.com/solutions
About Enlighten Clinical Solutions
Enlighten Clinical Solutions provides secure, cloud-based clinical operations and data management technology for life sciences organizations. The company’s integrated clinical trial platform is designed to support Electronic Data Capture (EDC), eTMF, and Clinical Trial Management System (CTMS) capabilities, enabling research teams to streamline data capture, trial documentation, and operational oversight while upholding stringent security and privacy standards.
Ellie Brightman
Enlighten Clinical Solutions
+1 800-579-5606
press@enlightenclinical.com
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