TransPerfect Life Sciences and Virtual Data Corp are coming together to deliver validated artificial intelligence solutions that support your clinical trial’s overall TMF health. TransPerfect’s Automate and Virtual Data Corp’s LiveTMF™ integrate directly on top of your existing electronic Trial Master File (eTMF) to serve as a continuous compliance layer. These connected AI tools enable clinical operations teams to improve completeness, timeliness, and quality.
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Every expected record has a cause, and your TMF Plan and SOPs already define what each one requires. LiveTMF applies those rules the day the event occurs, reconfiguring expected record lists (or "EDLs") using live study data. This closes the gap between what you expect your TMF to contain and what it actually does.
A site activates, an amendment takes effect, a case is assessed as a SUSAR, or a record fulfills a placeholder.
LiveTMF applies the rules already defined in the reference model, your TMF plan, other plans, and your policies and SOPs with the protocol as context.
The EDL automatically reflects what is owed, filed, or not yet due. The reason why, with references, is also available, providing regulatory and policy justification.
Can you explain exactly what your study owes, not just today, but on a specific date?
LiveTMF derives obligations from a study’s events and amendments and checks them against what was filed. The list recalculates and updates itself along with the rationale. You'll always be prepared to answer inspectors’ questions with an EDL that references what the study owed and what your team knew, at any point in the past.
less manual EDL management with LiveTMF, giving ClinOps teams weeks back every year and keeping the TMF inspection-ready.
grade given to a TMF that's too incomplete for inspection, as outlined in the 2026 MHRA GCP Inspection Guidance.
most-cited FDA inspection observation in FY2025: inadequate or inaccurate case history records, 21 CFR 312.62(b).
of critical and major GCP findings in the EMA GCP IWG 2024 report were essential document failures, the largest single category.
ai portal
LiveTMF reads the eTMF without changing anything about how sites and CROs file records or requiring additional software.
R&D
Automation is configured according to your TMF and SOPs and managed under your change-control procedures.
quality
Designed to support GAMP 5, 21 CFR Part 11 and Annex 11 requirements, with ALCOA+ audit trails.
LiveTMF adds a continuous compliance layer that sits directly on top of your eTMF, so you’ll never have to worry about outdated expected record lists again.
Schedule a demo today to see LiveTMF in action.
