Site activation essential documents, cross-checked in under an hour — and every break dated to the initiation visit
Every site packet cross-checked in under an hour, with one clear request per site.
See one case, screen by screen ↓A study start-up solution for clinical operations that checks each site's essential documents before its initiation visit. Six agents read every page of a site packet, line each investigator up across their documents, date every expiry against the SIV and draft one request per site. The study start-up lead confirms the findings and signs the green light.
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Before a site may enrol, the start-up team must hold a complete, current and consistent set of essential documents for it: the Form FDA 1572 or its equivalent — the Canadian Qualified Investigator Undertaking, the EU investigator and site suitability forms — signed CVs, medical licences, GCP certificates, financial disclosures, the delegation log, the ethics approval of the current protocol, the consent form, the lab certificate and normal ranges, the protocol signature page and the contract. A start-up specialist opens each PDF, types the dates into a tracker and compares names across forms by eye.
The errors that cost time are between documents, not inside one. A sub-investigator with eligibility and adverse-event tasks on the delegation log who is missing from Section 6 of the 1572. An IRB approval for protocol 2.0 when 3.0 is current. A GCP certificate that is valid today and lapses two days before the SIV. Found late, each sends the packet back for another round of about a week — and a certificate that lapses after the green light is found by the CRA on site, when the visit has to be moved.
Estimated hours for one 16–25 document site packet, reviewed by hand and with the solution.
Six agents read every page, line each person up across their documents and date every break; the start-up lead confirms and signs.
VLT-305 is a Phase 3, placebo-controlled study of veltrimab in moderate-to-severe ulcerative colitis, on protocol 3.0 (Amendment 2, Aug 28, 2026), with 12 sites in 7 countries and first patient in targeted for Nov 16. It is Oct 7. Here is what happens next, screen by screen, in the working solution.
Lena's home screen puts the 12 sites on one calendar, each a bar toward its SIV, with Today and First patient in marked. Three breaks are still to clear, five are requested from sites and 2 of 12 sites are green-lit. On the right, breaks are listed nearest initiation visit first, and a new packet from 104 Hill Country Digestive Research — 23 documents through the site portal at 07:40 — waits to be checked.
“Each site is a bar toward its initiation visit, broken where an essential document is missing, expired or inconsistent.”
Site 207, Ospedale San Lorenzo, has its SIV on Nov 4. Dr. Marco Gallo, a sub-investigator delegated eligibility and adverse-event assessment, completed GCP training on Nov 2, 2023, so his certificate lapses on Nov 2, 2026. His CV, investigator suitability form, Italian register entry, delegation log and declaration of interests all agree on name and site — written as “Marco Gallo, MD” on one and “GALLO Marco” on another. Only the date breaks.
“Certificate valid to Nov 2 · Initiation visit Nov 4 · 2 days short of the visit.”
One click on Draft request and the fix-request writer addresses Elena Rossi, the study coordinator, with Prof. Chiara Benedetti and the CRA Priya Raman in copy: one item, a refreshed GCP certificate for Dr. Gallo dated before Nov 2, and why. A switch shows the same request in Italian. Lena sends it; the break on the runway now reads “GCP · Dr. Gallo lapses Nov 2 · due Oct 14”.
The fix-request writer drafts; a person sends.
On the runway, Lena presses Check now on Hill Country's new packet. Packet intake sorts the 23 documents into 12 families and attaches them to 6 people. The field reader reads 61 pages and 214 fields — names, dates, signatures, versions. The people cross-checker, the version and expiry checker and the country rules checker then test them against the Oct 21 visit, protocol 3.0 and the United States list.
Each agent's step is shown as it runs, with what it found and how long it took.
Lena opens the packet. Two findings are high, one medium, one low; 42 of 46 checks passed. Dr. Kwame Mensah does medical tasks but is not on the Form FDA 1572. Meridian IRB approved protocol 2.0, not 3.0. Dr. Hannah Lowe's GCP certificate expired on Sep 12, 2026. The CLIA certificate for Hill Country Regional Laboratory runs to Nov 30, only 40 days after the visit. Each finding cites its pages and suggests a decision: ask the site, accept with a note, or not an issue.
Each person on the delegation log is matched to Section 1 or 6 of the 1572 and to their CV, licence, GCP certificate and disclosure. Dr. Mensah is line 4 of the log, delegated eligibility and adverse-event assessment from Sep 22, but not in Section 6 — and he has no financial disclosure. The coordinator Mia Alvarez and the pharmacist Daniel Ruiz have no medical tasks, so they need not be on the statement.
Anyone with eligibility, examination or adverse-event tasks (B, D, E) must be on the statement.
Lena takes the suggestions. The CLIA certificate is accepted with a note — “Renewal is routine and not due before activation. Reminder set for Nov 1 to collect the renewed certificate.” — which goes to Omar Haddad for a second approval. The other three become one request to Mia Alvarez, with Dr. Rafael Moreno and Sam Patel in copy, due Oct 12, sent through the site portal.
“Drafted by the fix-request writer from the findings you confirmed.”
Mia uploads a revised Form FDA 1572, Dr. Mensah's financial disclosure, the IRB approval of Amendment 2, consent form 3.0 and Dr. Lowe's new GCP certificate. The re-check keeps the 3 older versions and marks them superseded, finds Dr. Mensah in Section 6, the IRB approval of Amendment 2 dated Oct 6 and Dr. Lowe's training dated Oct 6, 2026. Nothing is open: 46 checks done, 1 accepted with a note.
“Ready for green light. 46 checks done · 0 open · 1 accepted with a note.”
Lena signs with her name, password and the meaning “I approve activation of this site”, confirming the essential records are complete and current. All 12 document families are complete. The 24 documents are filed to the eTMF in Zones 04, 05 and 08 with their metadata, the depot is told it may ship VLT-305 kits to site 104, and Sam Patel is asked to book the initiation visit.
From 23 documents arriving at 07:40 to a signed green light at 10:58, the same day.
The same study, seen by the five people who activate its sites — what their week looked like, and what it looks like now.
Six agents read every page, line each person up across their documents and date every break; the start-up lead confirms and signs.
Takes documents from the site portal and the start-up mailbox, classifies each into one of 12 document families, attaches it to the right site and person, and sets older versions aside.
Reads every page — scans, signatures and handwriting included — and pulls names, dates, signatures, versions, addresses, licence numbers, task codes and expiry dates, each with the passage it came from.
Lines up every person across the investigator statement, delegation log, CVs, licences, GCP certificates and financial disclosures, matches name variants and explains each mismatch.
Compares approvals, consent forms and signature pages with the current protocol version, and tests every expiry date against the site initiation visit and the validity window.
Applies each country's required list — Form FDA 1572 in the US, the Qualified Investigator Undertaking in Canada, the investigator and site suitability forms in the EU — and reports what is missing or not acceptable.
Turns the confirmed findings into one clear request to the site coordinator — what to send, why and by when — in English and, where the site prefers, its own language.
Confirms findings, signs the green light. The agents propose; a named person decides.
Ask in plain words about a site, a person or a rule — or say what to check. Every answer points to the passage behind it.
Which initiation visits are at risk?
Two sites have a break that is not yet requested. 402 Centrum Medyczne Odra (SIV Oct 30): Dr. Ewa Kowalczyk is delegated tasks from Sep 1, two weeks before her GCP training, and one log line is not initialled. 207 Ospedale San Lorenzo (SIV Nov 4): Dr. Marco Gallo's GCP certificate lapses on Nov 2, two days before the visit — his CV, suitability form and registration all agree.
What is blocking Hill Country from green light?
Four things, from the 23 documents that arrived at 07:40. Dr. Kwame Mensah is on the delegation log for eligibility and adverse-event assessment but not in Section 6 of the 1572, and needs a financial disclosure. The IRB approval is for protocol 2.0 — current is 3.0. Dr. Hannah Lowe's GCP certificate lapsed on Sep 12. The CLIA certificate ends Nov 30 — accepting it with a note is suggested.
Who must be on the 1572?
The PI in Section 1 and, in Section 6, everyone who makes a direct and significant contribution to the data — in practice anyone delegated eligibility, physical examination or adverse-event assessment (tasks B, D, E on the log). Coordinators and pharmacists who only consent, enter data or handle product are not listed.
Flag GCP certificates that lapse within 90 days of activation
Done. New check: GCP training must stay valid at least 90 days after the green light. Across the 12 packets it finds two people today: Dr. Hannah Lowe at Hill Country (lapsed Sep 12) and Dr. Marco Gallo at Ospedale San Lorenzo (lapses Nov 2). The rule is live in Settings and recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
The rules every packet is checked against are settings, applied to every packet and versioned. Change one, and the screen shows who it flags today.
| Setting | Default | Choose from |
|---|---|---|
| CV age | 24 months | 12 to 60 months, in steps of 6 |
| GCP training within | 3 years | 1 to 5 years |
| Validity after activation (licences and lab certificates) | 90 days | 30 to 180 days, in steps of 30 |
| Medical tasks need the investigator statement | On | On · Off |
| No task before training | On | On · Off |
| Approvals name the current protocol | On | On · Off |
| Green light signed by | Lena Ortiz | Lena Ortiz · Omar Haddad |
| Second approval for a finding accepted with a note | Omar Haddad | Omar Haddad · Lena Ortiz |
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 site initiation benchmarks — close to eight months to initiate a Phase II/III site; 25.7 weeks for a repeat site against 35.6 for a new one). Essential documents as described in ICH E6(R3) Appendix C, 21 CFR 312.53 and 21 CFR Part 54. People, sites, sponsors and studies named on this page are fictional — characters and sample data in the working solution.
A study start-up solution for clinical operations that checks each site's essential documents before its initiation visit. Six agents read every page of a site packet, line each investigator up across their documents, date every expiry against the SIV and draft one request per site. The study start-up lead confirms the findings and signs the green light.
The people cross-checker builds one row per person from the delegation log and the investigator statement. Anyone delegated eligibility, physical examination or adverse-event assessment must be in Section 1 or 6, and everyone there needs a CV, a licence or registration, GCP training and a financial disclosure. Names are matched across formats, and every mismatch cites both passages.
Yes. The version and expiry checker measures every date against the site's planned initiation visit: CVs against the CV age, GCP against the training window, and licences and lab certificates against the validity window after activation — 24 months, 3 years and 90 days by default. On the sample study it caught a GCP certificate lapsing two days before Bologna's visit, 28 days ahead.
Yes. The country rules checker applies each country's list: the Form FDA 1572 in the US, the Qualified Investigator Undertaking in Canada, and the investigator and site suitability forms, ethics committee opinion and declaration of interests in the EU. Requests can go out in English and the site's own language.
Yes. The agents propose findings and draft requests; they never confirm a finding, send a message or change a document. The study start-up lead confirms each finding and signs the green light, and a finding accepted with a note needs a second approval from the clinical operations director.
The packet is re-checked as soon as they arrive. Older versions are kept and marked superseded, findings the new documents clear are resolved, and when nothing is open the site is ready for the green light. On signing, accepted documents are filed to the eTMF with their metadata.
Yes. CV age, the GCP training window, validity after activation, the cross-document rules, the country requirement lists, the approvers and the document channels are settings, versioned and on the audit trail. A new rule can be described in one sentence and is added once you approve it.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your country checklists, protocol versions, study plan and a sample of past site packets — and it goes live once every quality gate has passed. We will walk you through it on your own packets 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 Site Activation Essential Documents on a sample of your own past site packets.