Use Case: Saving Time and Cost with AI in TMF Document Management

April 29, 2025

Use Case: Saving Time and Cost with AI in TMF Document Management

A mid-sized CRO managing 9,500 TMF documents annually faced increasing challenges with filing and metadata assignment. Each document required an average of 5–6 minutes to process manually.

The Problem

Manual document upload and metadata entry amounted to:

  • 950 hours annually (based on 6 minutes per document)
  • €47,500 in labor cost per year (at €50/hour average EU in-house rate)

This process also posed risks of human error and inconsistency.

The Solution

The CRO implemented an AI-powered eTMF solution with automated document classification and metadata fulfilment. The system reduced human involvement to minimal review and AI performance approval.

The Impact

  • 11 times reduction in manual time spent on document filing
  • Estimated ~900 hours saved per year
  • Annual cost savings of €40K+ 
  • Improved compliance and consistency with audit-ready metadata
  • Faster TMF completeness and quality tracking

Summary

By adopting AI in their TMF process, the CRO significantly improved operational efficiency, reduced costs, and increased confidence in their inspection-readiness. This case demonstrates how automation can turn TMF from a burden into a strategic asset.

MetricBefore AIAfter AI
Documents per year9,5009,500
Avg. time per document6 minutes0,5 minutes
Manual hours required950~80
Annual cost€47,500~€4,000
Risk of human errorHighMinimal

Looking to transform your TMF operations with AI? Let’s talk: contact@flexdatabases.com

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