Audit Fundamentals
What makes our TMF audits different from standard sponsor audits?
Standard sponsor audits focus on completeness percentages and SLA metrics. Our audits mirror actual regulatory inspection patterns – we look for the specific gaps that cause FDA Warning Letters, MHRA critical findings, and EMA major deficiencies. We’re aligned with what inspectors actually flag, not just internal KPIs.
Why do most TMF audits miss critical inspection risks?
There’s a major disconnect: internal audits check for document counts, but regulators judge “inspection-readiness” – can your TMF tell the complete, contemporaneous story of your trial right now? Our AI-powered approach identifies the metadata inconsistencies, access issues, and documentation gaps that actually stop inspections.
Top Regulatory Risks
What are the most critical TMF findings across FDA, MHRA, and EMA?
The “Big 5” that stop inspections:
- Missing essential documents – preventing study reconstruction
- Poor direct access – fragmented systems, denied access
- Back-dated filing – bulk uploads pre-inspection
- Unvalidated eTMF systems – audit trail gaps
- Lack of sponsor oversight – no QC evidence in TMF
What specific evidence do inspectors look for when citing “back-dated filing”?
Inspectors examine audit trails for bulk upload patterns, timestamps that don’t align with document creation dates, and metadata showing mass document transfers just before inspection. Our AI specifically flags these patterns by analyzing upload timing, version histories, and user access logs across your entire TMF.
AI-Powered Approach
How does AI improve TMF audit coverage compared to manual sampling?
Manual audits typically review 10-20% of documents. Our AI analyzes 100% of metadata to identify patterns, inconsistencies, and anomalies that would be impossible to catch manually. When we do targeted sampling, it’s guided by these AI insights to focus on the highest-risk areas – not random sampling.
Can your system detect the specific issues that lead to “inadequate case histories” citations?
Yes – we cross-reference documents across systems to identify missing source documentation, gaps in monitoring visit sequences, and incomplete safety reporting chains. Our natural language processing identifies when documents reference other files that aren’t properly linked or are missing entirely from the TMF.
Audit Process
How do you ensure our audit actually prepares us for inspection?
We simulate the inspection experience: testing direct access under time pressure, validating that your TMF can reconstruct study conduct without expert guidance, and ensuring all cross-system references work. If an inspector can’t find something or gets frustrated with access, we’ll identify that before they arrive.
What happens if our TMF isn’t audit-ready?
We assess readiness first – if foundational QC hasn’t been completed or major gaps exist, we’ll provide a roadmap to get you audit-ready rather than wasting time on a premature audit. Our goal is meaningful results, not just completing an audit checklist.
Need a deeper dive or a proof-of-concept AI pilot?
Contact us to schedule your TMF Audit+™