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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

Risk-Based Monitoring with Flex Databases 
October 1, 2025
Risk-Based Monitoring with Flex Databases 

Flex Databases combines deep clinical expertise with advanced technology to deliver a smarter approach to trial oversight. Our Risk-Based Monitoring (RBM) framework helps sponsors and CROs focus on what matters most, reduce effort and cost, and make faster, data-driven decisions – supported by Flex Databases’ EDC, central/remote monitoring, and AI analytics.  Why Risk-Based Monitoring?  How […]

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ICSR Reporting
September 30, 2025
ICSR Reporting

📑 Tracking regulatory submissions shouldn’t require endless spreadsheets.But for many PV teams, managing ICSR reporting across agencies means manual tracking, external task lists, and risk of missed deadlines. With Flex Databases’ improved Pharmacovigilance Submissions Tracker, everything is now in one place: ✔ Define flexible submission rules by drug, project, and conditions✔ Configure statuses to match […]

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Query Chat: Smarter Way to Manage Data Issues in Monitoring
Query Chat: Smarter Way to Manage Data Issues in Monitoring

Managing monitoring activities often means juggling multiple people, documents, and communication channels. Without the right tools, discussions about data discrepancies get lost in emails or chats, review cycles are disrupted, and KPIs are affected by unnecessary report declines. To solve these pains, CRAAM introduces a dedicated Query feature – designed to make handling data issues […]

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Subject Tracking & Invoicing – Data Import Wizard.
Subject Tracking & Invoicing – Data Import Wizard.

Cross-site budget setup can turn into hours of manual per-subject cost entry, slowing teams down and creating error risks. With Flex Databases’ Subject Tracking & Invoicing, you can now import Per Subject Costs directly from Excel using the Data Import Wizard. ✔ Speed up site budget setup✔ Reduce manual entry and errors✔ Import across projects […]

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