GCP inspection readiness, with every storyboard sentence backed by the trial record
Every likely inspection topic becomes a storyboard backed line by line by the trial record.
See one case, screen by screen ↓The inspection notice lands and the clock starts. Clinical QA has a few weeks to decide which topics the inspector will probe — the late SAEs, the consent on a superseded form, the data changes after soft lock, the CRO oversight — and to tell each one as a factual story the subject-matter expert can stand behind in the front room.
Most of those weeks go on finding the documents across the eTMF, CTMS, quality system and safety database, writing the storyboards, and then finding out — in the mock, or worse, in the inspection — that a sentence in the story is not in the record. Meanwhile documents filed after the notice sit in the TMF audit trail without a note-to-file, and a request from the inspector takes the back room most of half an hour.
Estimated split for preparing a sponsor inspection with a dozen storyboards, by hand and with the solution.
Six specialist agents index the record, find topics, draft, check, rehearse and fetch documents; the QA lead approves every storyboard.
FDA arrives at Northwind Bio on Monday October 26 for a sponsor inspection of VLT-302, veltrimab in plaque psoriasis, with a licence application under review. Here is the late-SAE storyboard for Site 114, screen by screen, in the working solution.
Dana opens the war room: readiness 84 of 100, 4 of 12 storyboards inspection-ready with 3 waiting for her signature, 94% of claims backed by the record, 14 open gaps. The readiness radar puts safety reporting lowest of the nine inspection areas, at 72.
“Claim Checker re-read SB-01 overnight — 1 statement is not in the record (Site 114 coordinator training).”
The storyboard is told in eight frames, from the issue to where it stands, owned by Dr. Maya Chen and in SME review. Frame 1: three of the six serious adverse events at Site 114 reached Northwind Bio later than the 24 hours the protocol requires, and none of them delayed an IND safety report to FDA. Beside it, the SAE reconciliation log from TMF 07.01.04 with the passage highlighted.
The Evidence Indexer reads 1,284 documents in scope where they live — 46 about this topic, across the eTMF, quality system and safety database. The Topic Finder confirms the topic against FDA CP 7348.810, the Storyboard Writer drafts 8 frames and 31 sentences, each with a citation, and the Claim Checker re-reads every one.
“Claim Checker — re-read every sentence: 30 supported · 0 partly · 1 not in the record.”
Site 114 learned of the three events on 18 February, 2 March and 9 March 2026 and reported them after 73, 70 and 49 hours. Below them, the 9 reports since the CAPA: a median of 6 hours. Click the citation and the passage in the reconciliation log lights up.
“The new coordinator, who started on 2 March, was trained on SAE reporting before she handled her first SAE.” The record says otherwise: the earliest SAE training for K. Brooks is the 20 March retraining, and she handled SAE-114-004 on 9 March. The checker opens gap G-01 for Omar Haddad, due October 14, and the CAPA actions show “Train new coordinator before SAE duties — No record”.
“The record cannot support this yet.”
The Claim Checker proposes a sentence the record fully supports: “CAPA-2026-031 retrained every member of the Site 114 team, including the new coordinator, on 20 March 2026.” Dana uses the proposed sentence. Frame 6 is now backed by the record and G-01 closes.
Once Dr. Maya Chen has reviewed it as the safety SME, SB-01 waits for Dana’s signature: 31 supported, 0 partly, 0 not in the record. She chooses the meaning — “Approved as factual and complete” — enters her password, and the signature is recorded with her name, date, time and meaning.
The slide preview shows what the inspector sees: the eight frames in order, marked approved by Dana Okafor on October 7. It downloads as slides or a PDF. Coaching notes and the coloured dots stay out of the export; the citations travel in the speaker notes.
“Every sentence on this slide is backed by the record — 31 citations travel in the speaker notes.”
The Inspector Simulator asks as an FDA investigator would: “Three SAEs at Site 114 reached you late. How do you know your corrective action worked?” Maya answers. Two of her four sentences are backed by the record; the claim that the new coordinator was trained before any SAE is not, and “our monitors check SAE timeliness at every visit” is only partly — monitoring plan v3 checks it at on-site visits, not remote ones.
Coaching: “Lead with the number: 9 of 9 reports within 24 hours since the retraining.” “Say ‘on-site visits’, not ‘every visit’.”
The cited answer is there to rehearse from. Then the inspector asks for the safety database query on SAE timeliness, March 2026. The Back-room Retriever logs the request, finds the document, checks it is the effective version and has it ready in 0:33 — and Omar releases it to the front room.
A person releases every document to the inspector.
The same inspection, seen by five of the people who carry it — what their weeks looked like, and what they look like now.
Six specialist agents index the record, find topics, draft, check, rehearse and fetch documents; the QA lead approves every storyboard.
Reads the eTMF, CTMS, quality system, safety database, training and IRT records in place and labels each document by TMF zone, site, document date and filed date.
Finds the topics an inspector is likely to probe — important deviations, late safety reports, consent errors, excursions, system changes — and maps each to the nine inspection areas.
Drafts each storyboard in eight frames — the issue, how we found it, timeline, impact, root cause, what we did, proof it worked, where it stands — every sentence cited.
Re-reads every storyboard sentence and every rehearsed answer against its sources — supported, partly supported, or not in the record — and opens a gap for each one the record cannot support.
Plays the inspector: asks the questions an FDA or MHRA inspector is likely to ask for each area, then checks the answer sentence by sentence and coaches.
Finds the documents an inspector asks for, checks version and completeness, assembles the send pack and keeps the request clock.
Approves, signs inspection-ready. The agents propose; a named person decides.
Anyone preparing for the inspection can ask in plain words — or tell it what to change. Answers cite the record.
Where are we weakest for the FDA inspection?
Two areas are below 80 on the readiness radar. The three lowest: safety reporting at 72 — SB-01, coordinator training not in the record; data handling at 76 — SB-05, 38 changes without approval and an unsigned memo; records and TMF at 80 — 37 documents filed after the notice. Readiness is 84. Closing the open high-severity gaps would lift it to about 88.
What will the inspector ask about safety reporting?
For safety reporting (CP 7348.810) expect: how do you know the Site 114 corrective action worked; was any IND safety report delayed; how are investigators told about new safety information. The first is still not rehearsed — Dr. Maya Chen is the person who answers it.
Add a rule: flag every document filed after the inspection notice
Done. New rule “Flag documents filed after the inspection notice” — the Claim Checker now marks any cited document whose filed date is after Oct 5, 2026 and asks for a note-to-file. It already applies to 37 documents; 11 have notes. Saved to the audit trail.
Draft a storyboard for the IB v7 acknowledgement at Site 029
I have started SB-13 · IB v7 acknowledgement at Site 029 in Records & TMF. The Evidence Indexer found 6 documents, including the site’s TMF completeness at 81%. The Storyboard Writer is drafting the eight frames now — it is on the Storyboards list as Drafted, owner Omar Haddad.
13 screens from the working solution, on its sample data. Pick one to see it large.
The authority, the scope, the approvers and the checks are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Authority and type | FDA — sponsor inspection (BIMO) | FDA sponsor (BIMO) · MHRA GCP systems · EMA product-related GCP |
| Scope the agents read | VLT-302 · 46 sites · Halvorsen Clinical Services · Larkspur IRT | Studies, sites and vendors |
| Storyboard frames | 8 frames, the issue to where it stands | The order every story is told in |
| Storyboard approval | Dana Okafor — Clinical QA | Dana Okafor · Priya Raman |
| Safety storyboards also reviewed by | Dr. Maya Chen | Dr. Maya Chen · Dana Okafor |
| Approve with an open gap | Off | On · Off |
| Partly supported when the source is a draft | On | On · Off |
| Flag numbers that differ from the clinical study report | On | On · Off |
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 · “typical” = published figures (MHRA GCP inspection metrics 2016–17 — critical findings at 7 of 15 sponsors). People, companies and products named on this page are fictional — characters and sample data in the working solution.
A short, factual story of one topic an inspector is likely to probe — a late SAE, a consent error, a temperature excursion — told so the subject-matter expert can present it in the front room. Here every storyboard has eight frames, from the issue to where it stands, and every sentence cites a document in the trial record.
The Claim Checker re-reads every sentence against its sources and marks it supported, partly supported, or not in the record. Drafts and unsigned documents never fully support a claim, and counts and dates are compared with the clinical study report on every rebuild.
It opens a gap with an owner, a due date and what is needed — for example the earlier training record, or a reworded claim. You can fix the record or use a sentence the record fully supports, and a storyboard with a statement not in the record is held back from export.
Yes. The Inspector Simulator asks the questions an FDA or MHRA inspector is likely to ask for each area, checks the SME’s answer sentence by sentence and gives coaching. The back room is timed on the same screen: each document request is logged, found, version-checked and released by a person.
No. The agents read the eTMF, CTMS, quality system, safety database, training system and IRT in place. They never move, edit or file a document, and they flag documents filed after the inspection notice so a note-to-file can be added.
The authority and type is a setting — FDA sponsor inspection (BIMO), MHRA GCP systems inspection or EMA product-related GCP inspection — and it sets the inspection areas and the question bank.
Yes. The Topic Finder proposes topics and a person decides which become storyboards. Only a named QA approver marks a storyboard inspection-ready, with a signature that records name, date, time and meaning, and a person releases every document to the inspector.
The Agentic Solution Engine builds and deploys it from your requirements — your inspection scope, your TMF plan and a sample of your trial records — and it goes live once every quality gate has passed. We will walk you through it on your own records first.
A trial synopsis becomes a checked first-draft protocol in days, in your own approved language.
1-min filmTMF CheckEvery trial document is read, filed in the right place and checked, so the file is inspection-ready every day.
1-min filmCSR WriterResults sections and patient narratives are drafted within days of database lock, every number linked to its table.
1-min filmWe’ll build storyboards for your next inspection from a sample of your own TMF and quality records.