The annual investigator's brochure update, drafted and cited — and every changed fact traced to every place it appears
Every IB updated in days, every number traced to its source.
See one case, screen by screen ↓A solution for medical writing and clinical teams that drafts the annual investigator's brochure update. Six agents collect every source since the last cut-off, draft each section as cited tracked changes, trace every changed fact to every statement in the brochure and find the other documents that quote it. The IB owner decides each fact and the medical lead approves the edition.
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Every investigational product's Investigator's Brochure is reviewed at least once a year (ICH E6). From the data cut-off the IB owner gathers every study report, integrated analysis, nonclinical and CMC report and protocol since the last edition from several systems, the section owners rewrite their sections, and someone recounts exposure — in spreadsheets, against a 100- to 250-page document.
A changed fact lives in many places. The half-life is in the Summary, in Section 5.1 and, as five half-lives, in the contraception period in Section 6. Exposure is in the Summary, in Table 5-4 and in the consent forms. Writers update one place and miss another, and nobody sees, before approval, which protocols, consent forms and pharmacy manuals still quote the old value — it comes back as a question from a site or an assessor.
Estimated split for one IB update from the data cut-off to a full cited draft, by hand and with the solution.
Six agents collect, draft, trace every changed fact and find the documents that quote it; the IB owner decides, the medical lead approves.
Veltrimab (NWB-1307), an anti-IL-23 monoclonal antibody in Phase 3 for plaque psoriasis and ulcerative colitis, moves from Edition 9 to Edition 10. The data cut-off was 31 August 2026, exposure rose from 1,212 to 1,846 participants, and the new edition is due on 30 October 2026. Here is what happens, screen by screen, in the working solution.
Lena owns 11 IBs. The brochure shelf ranks them by due date: Veltrimab Edition 10 due 30 Oct, 23 days away, then NWB-2290 and Corventa; Talmirex Edition 5 is submitted and approved in 6 of 9 countries. Veltrimab's cover reads 14 new sources since Edition 9, 24 changes drafted and its fact findings waiting.
“Each IB is reviewed at least once a year.”
The source collector found 14 documents since the Edition 9 data cut-off — 5 study reports, 3 integrated analyses, 1 nonclinical report, 1 stability report, 2 protocols, the study tracker and Edition 9 — and filed each against the section it affects. The section drafters wrote 24 tracked changes; the fact tracer traced 12 facts to 22 statements; the related-document finder found 8 places in 6 other documents.
Fact tracer: “12 facts traced to 22 statements in the brochure · the half-life waits for your decision.”
The Edition changes screen lays last edition's facts beside the proposed ones: exposure, study status, the ulcerative colitis dose, hepatic impairment, drug interactions, antidrug antibodies, the new prefilled pen, storage, developmental toxicity and two efficacy results. Every row has a switch. The change impact reads 19 statements updated in the brochure and 6 places in other documents; 3 statements are still behind the newest approved source.
“Nothing changes at the sites today: investigators keep Edition 9 until Edition 10 is approved in all 14 countries (est. Jan 2027).”
Participants exposed rises from 1,212 and 1,089 patient-years to 1,846 and 2,031, from the integrated exposure report. Where it appears lists the Summary on page 7 and Table 5-4 on page 66 — and section 2 of the open-label extension consent form, version 3, which still says “About 1,200 people have received veltrimab so far”.
The related-document finder never edits another document — it tells its owner.
Lena traces “Week 52 remission”. Clinical remission at Week 52 in ulcerative colitis comes only from VLT-303 interim analysis IA-2, a draft dated 14 Sep 2026 that is not approved. The tracer keeps it out and names the check: final, approved sources only.
“Week 52 remission stays out of the brochure · Final, approved sources only.”
The population PK report of 1,410 participants gives a typical half-life of 28.1 days. Traced and added, the half-life moves from about 26 to about 28 days in the Summary and Section 5.1, and the contraception period in Section 6 from 19 to 20 weeks. The counters move to 22 statements in the brochure and 8 places in other documents; no statement is left behind the newest source.
Two consent forms — VLT-301 version 4 and the open-label extension version 3 — still say “for 19 weeks after your last dose”.
The draft entry fills in: the half-life updated from approximately 26 to 28 days from PK-2026-04; the Summary updated to match; the contraception period moved from 19 to 20 weeks, about five half-lives, as protocol VLT-302 amendment 3 already states; and the two consent forms flagged to their study teams.
Lena sends Edition 10 to Dr. Maya Chen. The signature records its meaning — “I approve Investigator's Brochure Edition 10 for Veltrimab” — and a reason that carries the counts: 12 facts changed, 22 statements updated in the brochure, every one cited, and 8 places in other documents flagged to their owners.
The agents propose; the medical lead approves the edition.
Section 6 of the brochure now carries the ulcerative colitis dose, self-injection with the pen, the hepatic impairment guidance, the developmental study and the contraception period of 20 weeks — each change beside its source passage, here protocol VLT-303 version 2, with Accept, Edit and Reject for the section owner.
Section drafter: never changes text without a source; never accepts its own change.
The fact check lists the seven findings for Edition 10 — exposure at the old cut-off, VLT-201 described as ongoing, the contraception period, the interim Week 52 result, an antidrug antibody rate rounded two ways, two consent forms and the pharmacy manual — with the editions register and every other document that quotes a changed fact.
The same Edition 10, seen by the four people who carry it — what their update cycle looked like, and what it looks like now.
Six agents collect, draft, trace every changed fact and find the documents that quote it; the IB owner decides, the medical lead approves.
At the annual data cut-off, finds every document dated after the last IB cut-off — study reports, integrated analyses, nonclinical and CMC reports, protocols and the study tracker — and files each against the IB section it affects.
Drafts each IB section as the smallest set of tracked changes against the current edition, quoting numbers exactly and citing the source passage for every insertion and deletion.
Lists the facts the brochure states — exposure, study status, doses, presentations, storage, pharmacokinetic values, nonclinical margins, efficacy results — finds every statement of each in every section and compares it with the newest final source.
For every changed fact, searches the current protocols, consent forms and pharmacy manuals of the trials that use the brochure and lists each passage that quotes the old value, with its version, section and owner.
Makes numbers and derived statements — such as a contraception period of five half-lives — agree across the Summary and Sections 2 to 6, and proposes a change wherever two places disagree.
Writes the summary of changes by section with reasons and sources, and the cover-letter paragraph naming the other documents amended with the edition.
Decide and approve. The agents propose; a named person decides.
Ask about any brochure, where a fact appears or the update clock — or say what to change. Every answer points to its source.
What changes in Veltrimab Edition 10?
24 tracked changes from 14 new sources, across 12 facts. The biggest: exposure rises to 1,846 participants; the ulcerative colitis Phase 2b result; the new 150 mg/mL prefilled pen; and the completed developmental toxicity study. The half-life update, 26 to 28 days, waits for your decision because it moves the contraception period in Section 6.
Where does the Veltrimab half-life appear?
In 3 places in the brochure: the Summary, Section 5.1 and Section 6, where the contraception period of 19 weeks is five half-lives. And in 2 consent forms: section 9 of VLT-301 version 4 and of the open-label extension version 3. The population PK report gives 28.1 days; protocol VLT-302 amendment 3 already says 20 weeks.
Which other documents must change with Edition 10?
With the half-life included, 8 places in 6 documents quote a fact Edition 10 changes: consent forms of VLT-301, VLT-302, VLT-303 and the open-label extension, the VLT-302 pharmacy manual and protocol VLT-302 amendment 3. Their owners are told before submission, so both are amended together.
Add a check: flag translated summaries when a section changes
Done. The check Translated summaries is added to the fact tracer. When a section changes, it lists the translated IB summaries that must be updated — for Veltrimab, the Japanese and Chinese summaries.
13 screens from the working solution, on its sample data. Pick one to see it large.
How the update cycle runs, which checks the fact tracer applies and who decides — all settings.
| Setting | Default | Choose from |
|---|---|---|
| Cycle anchor | Annual data cut-off | Annual data cut-off · IB anniversary date · Date of the first edition |
| Due date | Cut-off + 60 days | Cut-off + 60 days · Cut-off + 45 days · Cut-off + 30 days |
| Reminders to the IB owner and writer | 30, 14 and 7 days before | 30, 14 and 7 days before · 45, 30, 14 and 7 days before · 14 and 7 days before |
| Prepare automatically at the cut-off | On — sources collected and changes drafted overnight | On · Off |
| Fact checks | 8 of 8 on | Each check on or off, from “Every statement cites a source” to “House template headings” |
| Other documents to search | Protocols, consent forms and pharmacy manuals | Protocols, consent forms and pharmacy manuals · Protocols and consent forms · Consent forms only |
| Section owners | Sections 5.2 and 6 · Dr. Maya Chen | One named person per section, from Summary to submission and country approvals |
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 brochure data · “target” = the design goal, measured in the live solution · “estimated” = our estimate of where an update's days go · “typical” = published rules and industry rules of thumb (ICH E6(R3) on the annual brochure review). People, compounds and companies named on this page are fictional — characters and sample data in the working solution.
A solution for medical writing and clinical teams that drafts the annual investigator's brochure update. Six agents collect every source since the last cut-off, draft each section as cited tracked changes, trace every changed fact to every statement in the brochure and find the other documents that quote it. The IB owner decides each fact and the medical lead approves the edition.
The fact tracer lists the facts the brochure states and finds every statement of each in every section, including derived ones such as a contraception period of five half-lives. The related-document finder then searches the protocols, consent forms and pharmacy manuals of the trials that use the brochure. On the sample brochure, 12 changed facts touch 22 statements and 8 places in other documents.
No. Only final, approved documents are cited. A value that exists only in a draft or interim analysis — on the sample data, Week 52 remission from an interim analysis — stays out, and the tracer names the check that kept it out.
No. The related-document finder never edits another document; it tells each owner the passage, the old and the new value, so the document is amended with the edition submission.
Yes. Every drafted change is accepted, edited or rejected by the named section owner, and every edition needs the medical lead's electronic signature with a reason. Every agent step and decision is on the activity trail.
Yes. The cycle anchor, due date, reminders, automatic preparation at the cut-off, each of the eight fact checks, the other documents to search and the section owners are all settings.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your IB template, a current brochure and a past update — and it goes live once every quality gate has passed. We will walk you through it on one of your own brochures first.
A checked first-draft protocol in days, in your approved language.
1-min demoeTMF Quality CheckAn inspection-ready trial master file every day, each site scored on what is due today.
1-min demoClinical Study Report AuthoringResults drafted within days of database lock, linked to tables.
1-min demoWe'll run Investigator's Brochure Authoring on one of your own past IB updates.