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

May 21, 2026
Vendor Oversight Under ICH E6(R3): Why Compliance Expectations Are Higher Than Ever

Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike. The updated guideline makes one thing very clear: sponsors remain fully responsible for trial quality, patient safety, and data integrity — even when activities are outsourced to external vendors. This includes ensuring […]

Senior Project Manager | eClinical

We are looking for seasoned Senior Project Managers who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy.  Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well […]

May 19, 2026
Clinical Trials Management Software: Key Features for CROs

CROs work in a fast-moving and highly complex environment. They manage multiple studies at the same time, often for different sponsors, across different countries, sites, and timelines. Each study comes with its own processes, reporting needs, and regulatory expectations. As this complexity grows, it becomes harder to keep everything aligned using separate tools or spreadsheets […]

Speaker Announcement Anna Petrovskaya at QA Virtual Conerence

Risk management used to live in spreadsheets, scattered documents, and endless review meetings.Not anymore 👀 That’s exactly what our QA Director, Anna Petrovskaya , will be speaking about at the International QA Virtual Conference. Her session,▶️ “Risk Management Automation in the GCP R3 Era,”will explore why traditional, document-based risk management approaches are no longer enough, 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.