Every trial document read, filed to the right TMF artifact and checked — with the gaps listed before an inspector finds them
Every trial document is read, filed in the right place and checked, so the file is inspection-ready every day.
See one case, screen by screen ↓A trial master file holds tens of thousands of documents, and they never stop arriving: monitoring visit reports and follow-up letters, delegation logs, CVs and GCP certificates, ethics approvals, safety acknowledgements, temperature logs, lab ranges — from dozens of sites, by portal, vendor drop and email. Each one has to be indexed to the right artifact, its site, date, version and signatures checked, and QC'd before it counts.
When filing falls behind, the backlog grows into thousands of documents and the file stops telling the truth about each site. Misfiled and missing documents are the most common inspection finding, and the expensive ones hide in plain sight: a new Sub-Investigator doing assessments who is not on the delegation log yet, mentioned only on page 3 of a visit report. Cleaning that up before an inspection takes months.
Estimated split for one document, by hand and with the solution — the totals follow the 38-day manual median and the 1.6-day target in the solution's own figures.
Four specialist agents classify, extract, check and chase every document; a QC reviewer confirms and signs.
Study VLT-302, Veltrimab in moderate-to-severe plaque psoriasis: 46 sites in 12 countries. At 08:12, 240 new documents arrive. Here is what happens next, screen by screen, in the working solution.
Lena opens the solution to the study as it stands: TMF completeness 94.2% — 36,412 of 38,655 expected documents — 37 open gaps across 14 sites, 9 of them overdue, and 91% filed within 30 days, up from 62% in July. At the top of what needs her: batch 0412, 240 new documents from 31 sites and 3 vendors.
“Site 014 · Zone 05 Site Management at 67% — Delegation log v2 missing since a new Sub-Investigator joined · no owner yet”
The batch came in by the site upload portal (162), the vendor file drop (51) and CRA email (27). Lena presses “Classify and file”. The agents read 612 pages of text, scans and spreadsheets, match each document to a TMF Reference Model v3.3.1 artifact, pull site, date, version, signatures and people named, and file every document at 90% confidence or more. 104 of the batch belong to Zone 05 Site Management alone.
“228 filed, 6 to confirm, 6 set aside. Completeness re-checked for 31 sites — Site 014 is still red in Zone 05 Site Management: the delegation log v2 was not in this batch.”
The site × zone heatmap compares what is filed with what each site should have at its milestone in the VLT-302 TMF plan. Two sites are below 80% in a zone: Site 014 Harbourview Research Centre in Rotterdam, at 67% in Zone 05, and Site 007 Westbrook in Leeds, at 78% in Zone 08 Testing.
Twelve of 18 expected Zone 05 documents are filed. The missing one at the top: Site Signature and Delegation Log v2. The Visit 3 monitoring report says Dr. Pieter Janssen joined as Sub-Investigator on 15 September and performed PASI and IGA assessments; the v1 log has no entry for him; the TMF plan expects an update within 14 days of a staff change. His CV, GCP certificate and financial disclosure are missing too.
“Assessments by staff not on the delegation log are a frequent inspection finding.”
The Zone 05 owner rule suggests Omar Haddad, the CRA for Site 014. Lena assigns the delegation log gap to him, due 13 October 2026, and the CV, GCP certificate and financial disclosure gaps go with it. Omar is notified by email and in his task list.
The agent drafts the letter to the PI, Dr. Elena Varga, from the visit report and the TMF plan: the updated delegation log adding Dr. Janssen from 15 September, signed and dated by her, with his CV, GCP certificate and financial disclosure form, by 13 October.
“Nothing is sent until you press Send.”
Six filings wait for a QC reviewer. First: 014_SiteVisitSummary_V3_signed.pdf, which arrived by CRA email. The classifier puts it at 64% as a Monitoring Visit Follow-up Letter (05.04.04), 29% as a Monitoring Visit Report and 7% as a Note to File — and shows why, each reason tied to a highlighted passage: a letter to the investigator with agreed action items, which says the full report is held by the sponsor. Against it: the title reads “Site Visit Summary”, which reports often use.
Lena checks the details read from the letter — study, site, document date 29 Sep 2026, visit date 22 Sep 2026, signed by Omar Haddad — and confirms the filing with her electronic signature. The meaning is recorded with it: “Reviewed — filing and details are correct”.
“Your signature, the time and the reason are written to the audit trail and cannot be changed.”
The letter is filed to 05.04.04 Monitoring Visit Follow-up Letter, marked “Filed · QC by Lena Ortiz”, and Site 014 Zone 05 rises from 67% to 72% — 13 of 18 expected documents. The delegation log gap stays open with Omar until the signed log arrives and passes QC.
The cleanup backlog is down to 310 documents from 4,820 in mid-August; the median time to file is 1.6 days, against 38 days by hand. 97.4% of automatic filings were kept as filed by QC, and study completeness climbed from 78.4% to 94.2% against a 95% target before database lock.
The same file, seen by the four people who carry it — what their week looked like, and what it looks like now.
Four specialist agents classify, extract, check and chase every document; a QC reviewer confirms and signs.
Reads each incoming document and matches it to a TMF Reference Model artifact — zone, section and artifact — with its top three candidates, a confidence and the reasons. Flags duplicates and documents that are not trial documents.
Pulls study, site number, document date, version, language, people named and every signature with its date — and checks that dates and signatures are present.
Compares what is filed with what each site should have at its milestone. Reads monitoring visit reports for staff changes, safety reports sent and amendments — each creates expected documents — and opens a gap with the evidence, a suggested owner and a due date.
Drafts the request to the site, sends reminders on the owner rules, and closes the gap when the document arrives and passes QC.
Confirms low-confidence filings and signs. The agents propose; a named person decides.
Ask in plain words about a site, a document or a gap — or tell it what to change. Answers point to the passages they rest on.
Why is Site 014 red in Zone 05?
Dr. Pieter Janssen joined Site 014 as Sub-Investigator on 15 Sep 2026 and has already done PASI and IGA assessments. The Visit 3 report says the delegation log was not updated; the TMF plan expects an update within 14 days of a staff change. That leaves 5 documents missing: delegation log v2, his CV, GCP certificate, financial disclosure — and the Aug–Sep screening log.
Why is the Site 014 follow-up letter only 64%?
Its title reads “Site Visit Summary”, which visit reports often use — so 29% went to Monitoring Visit Report. But it is a letter to the PI with agreed actions, and it says the full report is held by the sponsor. That makes it a follow-up letter (05.04.04). Confirming it lifts Site 014 Zone 05 from 67% to 72%.
Are we ready for an inspection?
Mostly. 33 of 46 sites are at 95% or more in every zone, every filed document has QC on the record, and trial-level zones are complete. Two sites need work first: Site 014 Zone 05 (delegation log after a staff change) and Site 007 Zone 08 (lab ranges and certificate). An inspection export needs Dr. Maya Chen's approval and gives the inspector read-only access for 30 days.
Add a rule: chase gaps open more than 14 days
Done. Gaps open more than 14 days now send a reminder to the owner and copy the clinical trial manager. Today that would chase 11 gaps, including 2 at Site 007 and 1 at Site 024. The rule is in Settings and on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
The index, the confidence to file on, the QC sample and who owns which gaps are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| TMF structure | TMF Reference Model v3.3.1 | TMF Reference Model v3.3.1 · TMF Reference Model v3.2.0 · Company TMF index 2026 |
| File automatically at | 90% confidence | 80–98 % |
| QC sample of automatic filings | 10% sample, weekly | 5% · 10% · 20% sample · Every document |
| Timeliness target | 30 days | 14 · 30 · 60 days |
| QC sign-off | Lena Ortiz | Lena Ortiz · Dana Okafor · Any QC reviewer |
| Inspection export approver | Dr. Maya Chen | Dr. Maya Chen · Lena Ortiz |
| Mark a document “not required” | TMF lead | TMF lead · Clinical trial manager |
| Gap owners and reminders | Zone 05 to the site CRA · Zones 03–04 to the start-up lead · Zone 06 to clinical supplies · remind 7 days before the due date, and on the day | Add rule |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample study data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Sources: TMF Reference Model · ICH E6 essential records. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Trial Master File Check reads every incoming trial document, matches it to its TMF Reference Model artifact, checks its site, date, version and signatures, and files it — or holds it for a QC reviewer. It then compares what is filed with what each site should have at its milestone, so the gaps are listed with owners before an inspection finds them.
The classifier reads every page and weighs the document type, title, author, addressee and content against the TMF Reference Model. It gives its top three candidates with a confidence, and explains its choice in plain sentences, each tied to a passage. It files on its own only at or above the auto-file threshold — 90% by default — with the date and signature checks passed.
Only above the confidence you set. Anything lower goes to a QC reviewer, who confirms or changes the artifact and signs. Consent forms, delegation logs, ethics approvals and safety acknowledgements always go to QC, and a weekly sample of automatic filings is QC-checked too — 97.4% were kept as filed in the working solution.
The completeness checker compares the filed documents with the expected-documents plan at each site's milestone, and reads monitoring visit reports for staff changes, safety reports and amendments that create new expected documents. Each gap opens with the evidence passage, a suggested owner from your gap-owner rules and a due date.
Yes. The TMF structure is a setting — TMF Reference Model v3.3.1, v3.2.0 or your company's own TMF index — and so are the auto-file threshold, the QC sample, the timeliness target, the approvers and who owns which gaps.
It keeps completeness by site and zone current every day, and prepares an inspection export: a read-only copy of the TMF with the index, each document's metadata, QC record and audit trail, and the open gaps with their owners. The clinical trial manager approves it before an inspector or auditor gets access, which ends after 30 days.
Yes. A QC reviewer signs every low-confidence filing, a person presses Send on every request to a site, and marking a document not required needs a reason and an approver. Every agent step and every human decision is on the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements — your TMF plan, filing SOPs and a sample of your trial documents — and it goes live once every quality gate has passed. We will walk you through it on your own documents first.
A trial synopsis becomes a checked first-draft protocol in days, in your own approved language.
1-min filmCSR WriterResults sections and patient narratives are drafted within days of database lock, every number linked to its table.
1-min filmProtocol Risk ReviewEvery draft protocol checked against past amendments, so avoidable changes are fixed before the committee meets.
1-min filmWe'll run TMF Check on a sample of your own trial documents.