How it works
LiveTMF understands your trial — continuously, and across time.
One live model of what your file knows: what's current, what was true at any past date, and why, each answer cited. Here's what that looks like in the product.
01
What it does
Four capabilities, one live model.
A living Expected Document List
Computed from study state, not maintained by hand. When Protocol Amendment 1 takes effect, every document it newly requires, across every affected site, appears instantly, correctly dated.
Amendment Impact Cascade
See the full downstream blast radius before you approve: which re-consents, IRB re-approvals, and re-filings an amendment triggers, at which sites, by when. Nothing falls through after the change.
Mock Inspection
Reconstruct the TMF as it stood on any past date. Two axes, Effective and Recorded, answer the only question an inspector really asks: "what did you know, and when did you know it?"
If inspected today
- CriticalS002 — delegation log not currentcitation · placeholder
- CriticalS001 — ICF v2.1 re-consent missingcitation · placeholder
- MajorS003 — monitoring visit report overduecitation · placeholder
- MajorS004 — financial disclosure incompletecitation · placeholder
Compliance Copilot
Explains every gap with its citation, drafts the Quality Issue or CRA follow-up, and files the approval into LiveTMF's layer, awaiting your sign-off, never your eTMF. Every claim carries its source; when it can't ground an answer, it says so instead of guessing.
Site S002 is blocked: its delegation log isn't current after Protocol Amendment 1.
grounded incitation · placeholderDraft Quality Issue
QI-2026-0017HIGHIn review
Awaiting approval — lands in LiveTMF's layer, not your eTMF.
02
The time model
Two axes: Effective and Recorded.
Effective is when something was true in the study. Recorded is when the file learned it. Holding both is what lets LiveTMF reconstruct the TMF exactly as it stood — and exactly as you knew it — on any past date, and answer an inspector's real question: what did you know, and when did you know it?
The time model is patent-pending.
Reconstructed view — the TMF as it stood on this date.
As of 12 Nov 2025
- CriticalS002 — delegation log not current21 CFR §312.53(c)
- CriticalS001 — ICF v2.1 re-consent missing21 CFR §50.27
- MajorS003 — monitoring visit report overdue21 CFR §312.56(a)
- MajorS004 — financial disclosure incomplete21 CFR §54.4
Shown on LiveTMF's demo study, DELPHI-001. Citations are placeholders pending sign-off.
03
The evidence
Every flag cites its source — ranked by inspection risk.
Each gap is traceable to the document and the regulation behind it, and the whole study rolls up to a single view of where you're exposed.
8 items · sorted by severity then inspection-risk weight
- MissingJHU
IND Safety Report (subj-1023)
07 Safety Reporting · 21 CFR §312.32(c)
- BlockedDFCI
Form FDA 1572 (updated sub-investigator)
03 Regulatory · 21 CFR §312.53(c)
- MissingMAYO
IRB-approved ICF v2.1 not on file (current version)
05 Site Management · 21 CFR §50.27
- WarningMDACC
IRB Continuing Review Approval
04 IRB / IEC · 21 CFR §56.109
- SatisfiedUCSF
Financial Disclosure (sub-investigator)
03 Regulatory · 21 CFR §54.4
- +3 more
Worst status per (site, zone) · count = matching / total.
Site by TMF zone status for demo study DELPHI-001, across six sites and nine DIA Reference Model zones. UCSF is largely satisfied; JHU, MDA, and DFCI carry the most missing documents, concentrated in IRB/IEC (zone 04) and Site Management (zone 05).
Worst status per site and TMF zone, across the nine DIA Reference Model zones: the exposed corners of the study at a glance.
Shown on LiveTMF's demo study, DELPHI-001. Citations are placeholders pending sign-off.
04
Architecture
Sits on top of what you already run.
LiveTMF reads from your existing eTMF (Veeva Vault, Phlexglobal, or another) through its API. No migration, no workflow change, no validation lift on day one. It never touches your eTMF's validated state.
Continuously reads · never writes back.
The future of the eTMF has arrived
See your own study in LiveTMF.
We'll stand up an overlay on a study of your choosing and walk your team through the gaps it surfaces, in the first hour, on your real data.
- No migration or validation lift
- Your eTMF stays the system of record
- Live cascade + mock-inspection walkthrough on your protocol