Site protocol questions answered with citations, consistent with every earlier answer, signed by the medical monitor
Every site question gets a cited, consistent answer in hours, signed by the medical monitor.
See one case, screen by screen ↓A site is screening a participant and the 28-day window is running. The coordinator emails the medical monitor: the ALT is a little over the limit, the PI thinks it is fatty liver, could we have an exception? The medical monitor has to find the current protocol text, check whether an amendment or a clarification letter changed it, remember what was told to the last site that asked, write the reply and file it.
Done by email across the 142 sites of one study, that takes days, and the answers drift. One site is told to repeat a TB test locally while the clarification letter says central laboratory. An answer given under protocol v2.0 stays in the FAQ after Amendment 2 changed the rule. Every inconsistent answer is a possible eligibility deviation — and enrolling a participant who misses an eligibility criterion is an important deviation.
Estimated split for one eligibility question, by email and with the solution, in hours.
Seven specialist agents read, sort, look up, compare, draft, guard and file every question; the medical monitor decides and signs.
Site 114 in Boston is screening participant 114-022 for VLT-302, a Phase 3 study of Veltrimab in plaque psoriasis. His ALT is 2.6 × ULN and the site asks for an exception. Here is what happens next, screen by screen, in the working solution.
Maya opens the solution on VLT-302: 3 drafts ready for her to sign, 2 due in 8 hours, a median reply of 3.1 h over the last 30 days. The hot-spot map shows where sites are asking — exclusion 9, tuberculosis screening, has 14 questions in 30 days and exclusion 11, liver tests, has 11.
“An answer from February is out of date — MI-0279 said any positive hepatitis B marker excludes. Amendment 2 now allows anti-HBc positive with undetectable HBV DNA. Still in the FAQ.”
A question comes in from Site 207 Aarhus through the site portal: hepatitis C antibody positive, RNA negative after cure in 2023. The agents read it, sort it to E-12 with a 24-hour clock, find protocol §5.2 E-12(c), find no earlier answer that conflicts, and draft a reply. It waits for Maya’s signature.
“Drafted in 19 seconds · ready for you”
MI-0417 from Priya Raman, study coordinator for Dr. James Whitaker at Boston Dermatology Research. The agents have read the message and its two attachments into seven facts: participant 114-022, 46, male, PASI 18.4 and BSA 22%, ALT 107 U/L at 2.6 × ULN, anti-HBc positive with HBsAg negative and HBV DNA not detected, screening day 14 of 28. The request for an exception is marked.
“Given the patient’s strong motivation, we would appreciate an exception to enrol him.”
One click on “How it was built” replays the run. The Inquiry Reader took 7 facts from the portal form and 2 attachments; the Topic Classifier set eligibility, E-11 and E-12, on the 24-hour clock; the Protocol Navigator found 6 passages in Protocol v3.0 · Amendment 2; the Consistency Checker found 3 prior answers, 1 out of date; the Reply Drafter wrote 7 sentences with every rule cited; the Exception Guard found the exception request.
E-11, liver tests: excludes — ALT 107 U/L is 2.6 × ULN against a limit of 2 × ULN. E-12, hepatitis B: allowed with conditions, with HBV DNA every 12 weeks. 8.1.3, re-screening: allowed once, from 4 Nov 2026. Citation 1 in the reply opens Protocol v3.0, §5.2 exclusion criterion 11, page 48 — the current version — with the limit highlighted.
Exception Guard: “The protocol does not allow exceptions to eligibility criteria, so the reply says so plainly and offers the re-screening route.”
Three signed answers on the same criteria. MI-0391 from Osaka, ALT 2.3 × ULN: not eligible, may re-screen — consistent. MI-0402 from Toronto, ALT 1.8 × ULN: eligible — consistent. MI-0279 from Porto in February, under protocol v2.0: any positive hepatitis B marker excludes — out of date since Amendment 2, with a button to retire it.
A conflict always stops the draft until a person looks.
Maya reads the decision and the reply, then signs: her name and role as signer, the meaning “Approved as medical monitor response”, and her password. Filing in the TMF with the decision log entry is always on; publishing to the study FAQ without participant numbers is her choice.
Answered in 1.9 h. The reply goes to Site 114, the decision is in the log with signer, time, criteria and protocol version, and it is filed in the TMF. A de-identified entry joins the study FAQ — “ALT is above 2 × ULN and the participant is anti-HBc positive with undetectable HBV DNA. Can the site ask for an exception?” — for every site in the study to read before they ask.
Liver tests reached 11 questions in 30 days, above the letter threshold. The agents collect the questions from 8 sites, group them into three themes — the cause of a raised ALT does not change the limit, exceptions are not possible, re-screening is the route — and draft a letter to all 142 investigators that explains, and does not change, the protocol. It goes to Lena for review.
The same question, seen by the five people around it — what their week looked like, and what it looks like now.
Seven specialist agents read, sort, look up, compare, draft, guard and file every question; the medical monitor decides and signs.
Reads each site question and its attachments; pulls out participant number, lab values with units and × ULN, dates and medicines, and flags any request for an exception.
Sorts the question by topic and protocol section (I-3, E-11, 6.4 …), sets urgency and starts the right clock.
Finds the exact passages in the current protocol, amendments, clarification letters, Investigator’s Brochure and manuals.
Compares the case with every signed earlier answer on the same criterion and marks each consistent, conflicting or out of date.
Writes a criterion-by-criterion decision and a plain reply to the site; every sentence carries its citation.
Checks the draft: no eligibility exceptions, no advice beyond the protocol, safety reporting reminders when a hospital stay is mentioned.
After the signature: sends the reply, writes the decision log, files in the TMF and publishes a de-identified FAQ entry.
Decides and signs. The agents propose; a named person decides.
It answers from the protocol, amendments, clarification letters, the Investigator’s Brochure and every signed answer in the decision log — always with the passage.
Which questions need me today?
Three drafts are waiting for your signature, soonest clock first. MI-0417 also carries an exception request — the draft states that the protocol does not allow exceptions.
Has anyone asked about indeterminate TB tests before?
Yes — exclusion 9 is the most-asked criterion in VLT-302: 14 questions in 30 days. The standard answer: repeat the IGRA once within screening, at least 7 days after the first sample, at the central laboratory. MI-0371 told Site 602 to repeat locally; it was corrected on 4 Sep.
Can the site ask for an exception?
No. The protocol states that the sponsor does not grant exceptions to eligibility criteria. The Exception Guard flags every request, and the reply always offers the route the protocol does allow — usually re-screening.
Add a rule: send every dose-hold question to the safety physician first
Done. Any question about holding or reducing a dose goes to the safety physician, Dr. Anil Mehta, before the medical monitor signs. It applies to both studies from now on, uses the urgent 4-hour clock, and is on the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Clocks, who signs, and the rules the agents follow are settings, set per study.
| Setting | Default | Choose from |
|---|---|---|
| Urgent dosing and safety clock | 4 h | 1 · 2 · 4 · 6 · 8 h |
| Eligibility clock | 24 h | 8 · 12 · 24 · 48 h |
| Everything else | 72 h | 24 · 48 · 72 · 120 h |
| Who signs for VLT-302 | Dr. Maya Chen | Dr. Maya Chen · Dr. Anil Mehta (a physician with the medical monitor role) |
| Backup when the signer is away | Dr. Anil Mehta — takes urgent questions after 2 hours without a reply | Dr. Anil Mehta · Dr. Omar Haddad |
| Suggest a clarification letter when a criterion reaches | 10 questions in 30 days | 5 · 6 · 8 · 10 · 12 · 15 · 20 |
| Who can read the FAQ | All sites in the study | All sites in the study · Sites in the same country · Study team only |
| After a protocol amendment | Flag them and ask Lena Ortiz to confirm | Flag them and ask Lena Ortiz to confirm · Retire them automatically |
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 (Tufts CSDD — ≈ 119 deviations per Phase 3 protocol). Context: FDA draft guidance on protocol deviations (Dec 2024) · ICH E6(R3). People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that takes a site’s question on eligibility, dosing, medicines or visits, finds the protocol text that answers it, and drafts a cited reply for the medical monitor to sign. This one uses seven agents to read the question, sort it by protocol section, find the passages, compare earlier answers, draft, check the wording, and file and publish after the signature.
The Consistency Checker compares every draft with each signed answer on the same criterion and marks it consistent, conflicting or out of date. A conflict stops the draft until a person looks, and after an amendment it flags published answers that cite changed text.
No. The Exception Guard marks every exception request and rejects any wording that could be read as a waiver; the rule cannot be turned off. The reply says plainly that exceptions are not possible and offers the route the protocol allows, such as re-screening.
Yes. The agents draft; only a physician with the medical monitor role can sign a medical decision, and nothing is sent to the site before the signature. The monitor can edit the reply, make it shorter, ask the site for more information or reassign the question.
The current protocol and its amendments, clarification letters, the Investigator’s Brochure, study manuals and every signed answer in the decision log. It cites only the current approved version and shows superseded text only as out of date.
After the signature, the FAQ & TMF Publisher sends the reply, adds the decision to the log with signer, time, meaning of signature and protocol version, and files it in the TMF. The decision log can be exported for the TMF as one PDF per study.
Yes. The clocks for urgent dosing and safety, eligibility and everything else, who signs for each study, the backup signer, the clarification-letter threshold, who can read the FAQ and what happens after an amendment are all settings.
The Agentic Solution Engine builds and deploys it from your requirements — your protocol, amendments, clarification letters and a sample of past site questions — and it goes live once every quality gate has passed. We will walk you through it on your own study 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 run the Medical Monitor Inquiry Assistant on your protocol and a sample of your past site questions.