Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

March 8, 2024

Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

Join us for an exclusive insightful webinar as we explore Artificial Intelligence (AI) within the Electronic Trial Master File (eTMF) system. Explore how AI can transform document management, simplify processes, and maintain compliance with regulatory standards.

What to Expect?

  • First-hand experience: Demo of automated filing of documents and metadata assignment in the eTMF system by Evgenia Michalcuk-Vrablik, 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.

Have burning questions about AI implementation in eTMF? This webinar offers the perfect opportunity to have them addressed.

You can now take a picture of the 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 innovations, we leverage AI for our daily chores. 

But! Aren’t we all also curious (and perhaps worried) about what should be done from the Sponsor or CRO perspective to ensure everything is compliant? Join our webinar to see AI in action and hear from our guest speaker from Deloitte on assuring compliance of embedded AI applications.

Guest Speaker:

Dr. Nico Erdmann is a Senior Manager at Deloitte Germany, where he is part of a Life Sciences team dedicated to transformation in the GxP environment. He leads the IT quality practice for CSV and AI Compliance in Life Sciences, overseeing all computerized validation projects, developing validation approaches for new technologies and IT quality frameworks. With respect to AI, he develops frameworks for ensuring GxP compliance of ML applications in regulated environments and supports companies in preparing frameworks for the EU AI Act. Nico is a standing member of the ISPE GAMP® D-A-Ch group on AI Validation and has published multiple articles on this subject.

Don’t miss out on this insightful webinar! Mark your calendars and register now to explore the transformative potential of AI in eTMF.

Register via LinkedIn

Date: 26th March.
Time: 17:00 CET.

Blog

April 28, 2026
Flex Databases x SOLTI taking the stage at #OCT2026

We’re heading to Barcelona for OCT 2026. And this time, we’re bringing a real story with us! Our colleague Evgenia will be speaking alongside Jaume Costa from SOLTI, our dear client and long-term partner, about the question many teams still struggle with: Who should own your eClinical systems: sponsor or CRO? Stream B: AI & […]

April 15, 2026
TMF Blinding: Removing the Complexity of Managing Blinded Studies

Blinded studies are critical for maintaining the integrity of clinical trials. But while the concept is straightforward, the operational reality is often anything but. For many clinical teams, managing blinding means dealing with: This creates a constant burden: Even with strict processes in place, a single misconfiguration can compromise the entire study. TMF Blinding in […]

April 2, 2026
CTMS for CRO Financial Management: Managing Clinical Trial Budgets and Investigator Payments

Financial management is critical because CROs must ensure that clinical trials remain within budget while generating expected revenue. Without proper financial oversight, organizations may experience delayed payments, incorrect invoicing, or reduced project profitability. A CTMS helps CROs maintain financial control and improve operational efficiency. Financial management is one of the most complex operational areas for […]

April 1, 2026
Risk-Based Monitoring (RBM) in Clinical Trials: A Comprehensive Guide to Modern Oversight

For decades, the clinical research industry operated under a manual, labor-intensive oversight model. The gold standard was 100% Source Data Verification (SDV) – a process where Clinical Research Associates (CRAs) traveled to sites to painstakingly cross-reference every data point in a Case Report Form against medical records. However, as trials have become more data-saturated and […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.