The first living TMF
Your eTMF stores the documents. It doesn't understand your study.
LiveTMF does. It holds the live state of your study in one connected model and computes your Expected Document List from it, recomputing the moment a protocol amendment takes effect, a site initiates, or a subject has an SAE.
Expected Document List · Now
As of 24 Jun 2026: 94% complete. 92 satisfied, 3 warning, 1 blocked, 2 missing.
The stakes
An inspection doesn't test your science. It tests whether you can prove it.
A regulator never sees your study — they see the file. What the file can't show, the study can't claim.
The problem
Every eTMF builds your checklist once — then freezes it.
Most eTMFs refresh the Expected Document List only on preset milestones, so it never recomputes when the study actually moves: ad hoc amendments, safety events, shifting site status. The list lags, and gaps surface during inspection prep instead of when they happen.
The shift
LiveTMF flips the model. The state of the study lives in the model; documents are evidence attached to it. The EDL isn't a checklist someone maintains. It's computed continuously from what's true about your study right now.
- Protocol Amendment 2amendment not reflected
- Site 07 — Initiation (SIV)
- SAE narrative · Subject 1042untracked
- Protocol Amendment 2
- Site 07 — Initiation (SIV)
- SAE narrative · Subject 1042now expected
What you get
Always current, provable on any date, and able to explain itself.
The three things a living TMF does that a frozen checklist can't.
Always current
The Expected Document List recomputes itself as the study changes: amendments, site activations, safety events. Nobody re-templates anything.
Any past date
Scrub time back to any date and see exactly what you knew, and when you knew it, for a mock inspection or an auditor.
Explained & cited
Ask the Compliance Copilot "why is this site blocked?" and get a grounded answer with the regulatory citation. Every gap comes with its rule and a drafted fix.
The full product — the cascade, the mock inspection, the evidence — is one page deeper.
See how it worksThe evidence
Every flag cites its source.
Each gap LiveTMF surfaces is traceable to the document and the regulation behind it, ranked by inspection risk so the most exposed items rise first.
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
Shown on LiveTMF's demo study, DELPHI-001. Citations are placeholders pending sign-off.
The difference
Why LiveTMF
How LiveTMF compares to a traditional eTMF.
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 builds a live, time-aware model of your study underneath the documents you already have, and starts surfacing gaps in the first hour.
It runs as an intelligence overlay that surfaces the mission-critical gaps, explains them, and drafts the follow-ups, while your eTMF stays the system of record. Its patent-pending, time-aware foundation is why it answers questions a document repository structurally can't.
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