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Recording: AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

March 29, 2024

Recording: AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

Have questions about AI in eTMF? This is the perfect opportunity to get them answered.

You can now take a picture of a document with your phone, email it to eTMF, or drag and drop a document into eTMF, and it will be automatically filed in the correct place with automatically added metadata. Embracing innovation, we leverage AI for our daily chores.

✔️ First-hand experience: Demo of automated filing of documents and metadata assignment in the eTMF system by Evgenia Michalčuk-Vráblík, Flex Databases.

✔️ AI validation and control: What should be delivered by the tech provider, presented by Malik Bilgin, Flex Databases.

✔️ Assuring GxP compliance of embedded AI applications: The customer perspective, presented by Dr. Nico Erdmann, Deloitte.

Table of contents

Blog

Everest CRO Experience with Flex Databases
July 3, 2025
Everest CRO Experience with Flex Databases

Dana Leff Niedzielska, MBA, SVP of Global Clinical Operations at Everest Clinical Research, shares her experience using Flex Databases’ CTMS and eTMF. In this interview, Dana highlights how Flex Databases supports Everest CRO’s clinical operations. Learn why Everest chose Flex Databases as their trusted technology partner and why they continue to rely on and trust […]

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What’s New This June: Smarter Imports, Cleaner Reports, and More Flexible APIs
July 1, 2025
What’s New This June: Smarter Imports, Cleaner Reports, and More Flexible APIs

Pre-Validation for CRA Reports The Monitoring Activity report tab now features a validation preview. Users can check for missing fields and review validation messages before generating the final report – enabling more accurate submissions and reducing the need for rework. Bulk Imports for Milestones and Assumptions You can now bulk import project milestones and assumptions […]

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ICH GCP E6(R3) is about to go live in the EU
June 24, 2025
ICH GCP E6(R3) is about to go live in the EU

The countdown is on – ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared! As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients: […]

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Checklist: Migrating from a Legacy TMF to an eTMF
June 19, 2025
Checklist: Migrating from a Legacy TMF to an eTMF

Many clinical trial teams still rely on a legacy TMF – whether that means physical binders or outdated digital folders lacking structure and traceability. These systems often fall short in today’s increasingly regulated, fast-paced environment, making oversight and compliance more difficult. That’s why more sponsors and CROs are transitioning to a modern eTMF. A modern […]

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