How We Work - Audit & TMF Audit+™

We tailor our collaboration to fit your needs—whether you’re seeking a traditional TMF audit or exploring AI-driven TMF tooling. In both cases, our process follows five clear phases:

Consultation & Discovery

• Traditional Audit: We meet to understand your study phase, eTMF environment, and specific compliance concerns.

• AI Pilot: We discuss your current QC/internal‐audit workflows and identify metadata or sampling challenges you’d like to address.

Define Requirements & Scope

• Traditional Audit: We agree on document types, sampling percentages (typically 10–20 %), stakeholder interviews, and cross-system checks.

• AI Pilot: We outline metadata fields to extract, expanded sampling targets, and API integration requirements.

Agreement & Onboarding

• Execute a mutually approved Statement of Work and NDA.

• Establish secure, read-only access to your eTMF (and ancillary systems), plus API credentials for the AI pilot.

Execution & Collaboration

• Traditional Audit: Our Lead Auditor and Co-Auditor conduct the manual review, interviews, spot-checks, and draft findings.

• AI Pilot: In parallel, our prototype LLM connects via API to your TMF, pulls metadata, and flags additional files for review.

Review, Deliver & Plan Next Steps

• We present combined findings in a close-out meeting, deliver your Findings Log, Draft/Final Audit Report, and (for pilots) the Metadata Insights Brief.

• You decide on remediation actions, ongoing QC improvements, or full-scale AI adoption—backed by our recommendations and support.

This structured, transparent approach ensures you get exactly the TMF assurance you need, with minimal overhead and maximum flexibility for future growth.

Additionally with TMF Audit+™?

• AI-Enabled Human Audit: Combine the power of machine-driven analysis with the expertise of our senior TMF auditors for deeper, faster insights.

• 100 % Document Coverage: No more 10–20 % sampling; we review every file in your Trial Master File so you can quantify and eliminate risk.

• Transparent Beta Pilot: Our AI toolkit is currently in beta. See its added value firsthand—and if it meets your needs, enjoy a 25 % discount on your next audit.

Learn more today.