Clinical organizations are under increasing pressure to modernize trial operations with AI and automation, while still meeting the uncompromising demands of regulatory inspection.

Inspection readiness hasn’t changed. But the complexity of getting there has.

Even with mature eTMF and quality systems in place, many teams continue to face the same challenges:

• Incomplete or inconsistent documents entering the TMF 
• Manual QC and reconciliation cycles that slow submissions
• Limited traceability across document transformations and workflows
• Increased risk during inspections due to gaps in documentation quality

At the root of these challenges is a persistent issue: clinical documents are not standardized, validated, or trustworthy enough at the point of intake.

This panel brings together leaders across the life sciences ecosystem, including consulting partners and technology providers, to explore how organizations are addressing this upstream problem and transforming their approach to TMF quality and inspection readiness.

We’ll walk through practical approaches to:

• Standardizing and validating documents before they enter the TMF
  
• Reducing ongoing QC burden through confidence-based workflows
  
• Ensuring traceability across document lifecycle for inspection defense
  
• Enabling AI and automation with trusted, structured clinical content
  

The goal: move from reactive QC and inspection anxiety to continuous inspection readiness, by design.

What You’ll Learn

1. Why TMFs still fail inspections (despite modern systems)
   Where document quality and process gaps persist, and why they matter.

2. How to improve TMF quality upstream
   Approaches to standardization, validation, and completeness before documents enter the TMF.

3. How to reduce QC burden and rework
   Using confidence-based workflows to focus human review where it’s actually needed.

4. How to ensure inspection-ready traceability
   Creating a defensible record of document intake, transformation, and validation.

5. How to enable AI without increasing compliance risk
   Ensuring clinical documents are structured, trustworthy, and usable for downstream AI and analytics.

Who Should Attend

• Clinical Operations & TMF leaders responsible for inspection readiness
• Regulatory Affairs & Submission leaders
• Quality & Compliance leaders (GxP, audit, inspection)
• Clinical Systems & IT leaders (eTMF, RIM, Veeva ecosystem)
• Data & AI leaders supporting clinical and regulatory workflows

‍
What this is (and isn’t)
This is a practical walkthrough of modern intake patterns, how to transform unstructured trial documentation into a compliant, preservation-grade, inspection-defensible state with the accuracy and traceability regulated teams need.
This isn’t a “replace your TMF” pitch.

Our Speakers

 Head of Product Management | Adlib Software

Mickey Garcia has 25+ years of experience in enterprise document and quality management software for Life Sciences, working with companies such as Abbott, AbbVie, Medtronic, Johnson & Johnson, GSK, P&G, Smith & Nephew, and Teva. He has held roles in strategy, product management, presales, and services for Adlib OEM partners like Dassault Systèmes (ENOVIA) and MasterControl, as well as leadership positions at M-Files and Epicor ECM (DocStar). Earlier, he spent seven years at Johnson & Johnson in operations, quality, and IT, is a certified Lean Six Sigma Black Belt, and holds an engineering degree from the University of Florida and an MBA from Stanford University.