May 14, 2026 1:00 PM
ET
|
Virtual

Are Clinical Document Workflows Ready for AI? Bridging the Gap Between Human Validation and Scalable Automation

This is as a cross-ecosystem discussion on TMF quality and inspection readiness, exploring why document variability still forces manual review and what leading teams are doing to reduce risk while preparing for AI-driven workflows

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.

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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.

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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

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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

Suzanne Turner

Suzanne Turner

TMF Consultant
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ICE Consulting, LLC

Suzanne Turner is a TMF Subject Matter Expert and Founder of ICE Consulting, with 10+ years of experience supporting sponsors and CROs including PRA Health Sciences. She specializes in TMF health, inspection readiness, and compliant process design, partnering with teams to close gaps and optimize operations. A member of the CDISC TMF Reference Model Steering Committee, she helps shape global TMF standards. Through her podcast Heart of the Trial and “Inform, Connect, Engage” approach, Suzanne is known for bridging strategy with hands-on execution and elevating how organizations understand and manage TMF.

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Kevin Anderson

Kevin Anderson

Leading AI Enablement & Transformation across Global Development Operations | Clinical Operations Executive
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Kevin Anderson is a Clinical Operations executive with over 25 years of global experience leading complex drug development programs from early development through registration. He has held senior leadership roles at leading biopharmaceutical companies including Moderna, Alexion Pharmaceuticals, PTC Therapeutics, Shire, and AlloVir, where he has led global teams, delivered inspection-ready programs, and supported multiple BLA submissions and regulatory inspections, with deep expertise in rare disease. He also serves on the Development AI Center of Excellence and founded the Clinical AI Innovators Network, focused on advancing practical, responsible AI adoption across drug development.

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Benjamin O’Connor

Benjamin O’Connor

Strategic Account Executive, Life Sciences
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Adlib Software

Benjamin O’Connor is a Global Strategic Account Executive at Adlib, partnering with life sciences organizations to bring order to messy, unstructured content and reduce risk in document-heavy workflows. He brings deep life sciences go-to-market experience across eTMF/clinical operations platforms and quality/compliance systems, having held business development roles at TransPerfect Life Sciences, Phlexglobal, and ComplianceQuest. Ben is focused on practical ways to improve submission and information management readiness, by strengthening document accuracy, consistency, and validation upstream.

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MANUFACTURING

Adlib: The Foundation for DocumentAccuracy in Chemical Refining

When we made the decision to change rendering solutions, we looked towards3 separate vendors. Overall, Adlib seemed more mature as a software option.

Challenge
Legacy conversion tools couldnʼt handle the volume and complexity of engineering files, forcing constant IT intervention and delaying CAD conversions into shareable formats. Flat TIFF outputs were unsearchable and lost layer previews—slowing collaboration, creating inefficiencies, and weakening archival practices.

Solution
Safeguarded engineering Adlib improved efficiency, cut administrative overhead, and safeguarded engineering drawings to reduce legal risk. Engineers and contractors gained faster access and smoother collaboration, while IT reduced workload, support needs, and infrastructure costs with a smaller server footprint.

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MANUFACTURING

Adlib: The Foundation for DocumentAccuracy in Chemical Refining

When we made the decision to change rendering solutions, we looked towards3 separate vendors. Overall, Adlib seemed more mature as a software option.

Challenge
Legacy conversion tools couldnʼt handle the volume and complexity of engineering files, forcing constant IT intervention and delaying CAD conversions into shareable formats. Flat TIFF outputs were unsearchable and lost layer previews—slowing collaboration, creating inefficiencies, and weakening archival practices.

Solution
Safeguarded engineering Adlib improved efficiency, cut administrative overhead, and safeguarded engineering drawings to reduce legal risk. Engineers and contractors gained faster access and smoother collaboration, while IT reduced workload, support needs, and infrastructure costs with a smaller server footprint.

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Insurance

Insurance Giant Automates Heavy Admin Work in Claims, Saving Millions

Insurance giant automates heavy admin work in claims, saving millions

Challenge

As full-time employees (FTEs) struggled to manually process 90k claim-related documents each day to meet the company SLAs, the claims department overhead was getting out of hand. In addition, customer frustration and increased churn was a direct result of response times being many days from the customer’s claim submission.

Solution

Adlib optimized the claims-processing workflow by automating the ingestion, digitization, intelligent assembly, and publishing of compliant claims in PDF format. This transformation significantly minimized the manual effort required from FTEs, allowing them to concentrate on claim approvals and improving customer relationships. As a direct outcome, the company saw a remarkable 90% reduction in administrative work tied to pre-processing claim documentation. This in turn slashed their operational budget by $6 million. What’s more, overall customer service satisfaction improved as the efficiency boost dramatically accelerated customer response times from days to hours.

Insurance giant automates heavy admin work in claims, saving millions
Insurance

Modernizing Claims Processing & Document Management Workflow

“We very quickly realized that Adlib was the right tool for us — it was the only PDF rendition product out of the seven or eight we looked at that met our requirements for 100% fidelity and integration.” — Director of Architecture & IS Risk

Challenge

The insurance company needed to incorporate an automated PDF rendering capability with high-fidelity output into its workflow that would integrate with its Guidewire ClaimCenter® claims processing system and IBM® FileNet® repository.

Solution

To modernize the application systems supporting its P&C operations, the insurance company embarked on a major, multi-year initiative—its Enterprise Systems Renewal Strategy—that has already seen the introduction of a new Broker Transaction Portal and a new Claims Processing system. Ultimately, the program will also see the company completely revamp its existing Policy Administration system and the ERP system used for managing financial processes.

Modernizing Claims Processing & Document Management Workflow
Life Sciences

Pharma manufacturer minimizes compliance risk in batch delivery

“Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging. Adlib is integrated with Enovia, our active quality management tool. We rely heavily on that tool,” – Sr. Manager Platform

Challenge

This pharma manufacturer faced significant challenges in managing the diverse types of files involved in their batch delivery workflows. The necessity to render every file type into PDFs for consistent storage was complicated by the variety of materials they handled, including product specifications, ingredients, formulas, raw materials, and packaging details. This complexity made it difficult to maintain a standardized and efficient document management process, leading to process inefficiencies, documentation inconsistencies and, ultimately, a compliance risk.

Solution

Tthe company implemented Haistaq into their batch delivery, quality assurance and manufacturing workflows. Adlib's robust rendering capabilities allowed for the automatic conversion of all file types into standardized PDFs, regardless of their origin. This streamlined the document management process, ensuring that all materials, from product specifications to packaging specifics, were consistently and efficiently stored as PDFs. As a result, the company achieved greater efficiency in their workflows, improved the consistency and accessibility of their documentation, and reduced the complexity and manual effort previously required to manage diverse file types. This implementation also enhanced compliance and operational efficiency, supporting their commitment to quality and regulatory standards.

Pharma Manufacturer Minimizes Compliance Risk in Batch Delivery

Put the Power of Accuracy Behind Your AI

Whether you’re scaling GenAI, modernizing regulatory submissions, or simply trying to get out from under manual document work, Adlib helps you turn unstructured content into a reliable asset. Not a hidden risk.

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