Webinar Recording: AI Automation in Clinical Content Management
Investment in eTMF systems has not changed how documents get into them: classification, metadata entry and QC remain largely human-driven. Quality issues are still found retrospectively (at QC sampling or inspection preparation) rather than at the point of filing. Both tasks are well suited to AI automation, provided control and accountability stay with the TMF owner.
What was Covered?
In this session, Kasper Skov Kjær, Solutions Architect and AI Initiatives Lead at BASE Life Science, demonstrates two capabilities from the BASE AI eTMF Suite operating on live content in the Live System: Auto-Classification with metadata association, and ALCOA+ Document QC.
You’ll learn:
- How incoming documents are identified, classified to the TMF structure and assigned metadata
- How ALCOA+ checks run on every document, with thresholds set per check and quality issues created directly in the Live System
- How human-in-the-loop review is designed into the workflow, and how AI actions and reviewer decisions are captured in the Live System audit trail
- How confidence scoring can progressively reduce the share of outcomes requiring full human review as trust is established
- What content that arrives classified, complete and quality-checked means for archiving and long-term retention
The session concludes with a Q&A.
This webinar recording is ideal for TMF, clinical operations, quality and IT professionals responsible for eTMF content quality and inspection readiness, or evaluating AI in a regulated setting.
To access the recording, fill out the form below:
Annabel Allum
Annabel is a Marketing Executive at Arkivum and joined the business in 2022. She is responsible for managing various operational marketing activities including email, CRM, website management and campaign support.
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