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Organize, track, and maintain clinical trial documentation with a compliant eTMF system that ensures audit readiness and simplifies regulatory submissions.
Managing trial documentation is one of the most challenging aspects of clinical trial oversight, especially in highly regulated industries like pharmaceuticals and biotechnology. ACE® eTMF Management transforms your document handling processes, ensuring they are structured, traceable, and fully compliant.
Leverage ACE Clinical’s drag-and-drop functionality to effortlessly organize trial-related documents into the appropriate sections and folders within the electronic Trial Master File (eTMF).
Store all essential documents in a secure, cloud-based system, providing global teams with consistent access to the latest versions.
Align your eTMF with industry standards like ICH E6(R2) and enable quick adjustments for study-specific requirements.
Monitoring trial milestones is critical for staying on schedule and maintaining regulatory compliance. ACE Clinical integrates milestone functionality to provide a clear view of trial progress.
Define key milestones for each trial phase, from study initiation to close-out, ensuring alignment with your project plan.
Create dependencies between milestones and tasks to manage workflows efficiently and avoid delays.
Gain instant insights into milestone completion statuses, helping stakeholders track trial progress and identify bottlenecks.
ACE Clinical ensures your trial documentation remains audit-ready and compliant with global regulatory standards.
Maintain a complete and traceable history of document submissions, approvals, and updates to satisfy regulatory bodies like the FDA, EMA, and MHRA.
Track document versions and user interactions to ensure data integrity and security.
Generate comprehensive document summaries and milestone reports to present to inspectors with confidence.
ACE Clinical is designed to support cross-functional collaboration and improve operational efficiency throughout the clinical trial process.
Enable multiple teams to work within the eTMF simultaneously while maintaining full control over access and edits.
Generate a tailored list of expected documents for each milestone or trial phase, ensuring nothing is overlooked.
Use built-in analytics to track documentation trends, identify gaps, and optimize trial processes.
Maximize the value of your eTMF management with ACE®.
