Adverse event case intake, read, coded and drafted before anyone opens the report
Every side-effect report becomes a cited case in minutes, filed with days to spare.
See one case, screen by screen ↓Side-effect reports do not arrive as cases. They arrive as a pharmacist’s email with a lab PDF attached, a consumer’s web form, a partner’s E2B message at two in the morning, a call-centre note, a journal article. Someone has to read each one, decide whether it is a valid case at all, check it is not a report the company already has, and code every event and medicine before the medical review can even start.
Then comes the narrative, written by hand from the same documents, and the seriousness and expectedness calls against the reference safety information. A serious, unexpected case is on a 15-day clock from Day 0, and a fatal or life-threatening SUSAR on seven. When most of the team’s hours go on triage, coding and typing, the physician’s judgement gets the least time of all.
By hand: estimated split of a typical 60–120 minute case. With agents: the median agent time per step on the working solution’s dashboard.
Six specialist agents read, check, code and draft every report; a safety physician confirms and signs.
At 07:12 on 6 October a community pharmacist emails the Drug Safety mailbox about a patient on Veltrimab with yellow skin and very high liver tests. Here is what happens next, screen by screen, in the working solution.
Maya opens the solution to 46 new reports since yesterday, every one read and coded by the agents. Three serious cases have a clock running, the next due Oct 10 on a 7-day clock, and five are drafted, cited and waiting for her review. First on her list is the pharmacist’s email.
“Possible liver reaction – patient on Veltrimab · CI-26-04817 · Pharmacist email · serious, unexpected · potential Hy's Law · drafted in 3 min”
The email from Priya Raman, PharmD, at Hillcrest Pharmacy in Dayton, Ohio, comes with one attachment, lab_results_28Sep.pdf. The report reader finds 21 facts in 38 seconds. The validity checker, duplicate detector, coder, assessor and narrative writer follow, each step shown with what it found — then the case waits for Dr. Maya Chen.
Every fact on the email is highlighted where the reader found it.
All four minimum criteria are in the first email — a pharmacist, a patient R.K., 58, female, the suspect product Veltrimab and the event — so Day 0 is Oct 6 and the 15-day clock runs to Oct 21. Three similar Veltrimab cases were compared; none is the same case. The assessor flags a potential Hy’s Law case: ALT 10.3 × the upper limit with total bilirubin 3.3 ×, alkaline phosphatase below 2 ×, viral and obstructive causes excluded.
“Read, checked, coded and drafted in 2 min 4 s · received 07:12, ready 07:15”
Drug-induced liver injury (PT 10072268, hepatobiliary disorders), jaundice, fatigue, ALT increased and blood bilirubin increased — the lab terms coded from the hospital report with their values beside them. Veltrimab 150 mg subcutaneous every two weeks, the indication psoriasis, the drug withdrawn on Sep 29, and atorvastatin and ibuprofen as concomitant medicines. Each field shows a confidence and a number that opens its source sentence.
The verbatim term stays next to every code; low-confidence codes are flagged for review.
In house order: the source and reporter, the patient, the concomitant medicines, the product and dates, the event course about 15 weeks after starting, the lab values and serology, the withdrawal, and the outcome — ALT down to 188 U/L on Oct 4, still in hospital. It notes that follow-up has been requested for medical history, alcohol use and the date the fatigue began. Maya can edit it or ask for a redraft.
No causality opinion in the narrative — that is the physician’s.
The assessor has proposed serious for hospitalization and medically important, and unexpected: the Veltrimab core data sheet, version 7.0, says “No hepatobiliary adverse reactions have been identified for Veltrimab.” For causality it only suggests: possibly related — plausible timing and improvement after stopping, with three years of atorvastatin as a possible alternative cause. Maya chooses Possibly related herself.
The signing screen repeats what she is approving — Hospitalization and Medically important, Unexpected (unlisted), Possibly related — and the meaning, medical review approval. She signs with her password. Unless every field points to its source sentence, the case cannot be signed.
“Your name, the time and the meaning of this signature are stored with the case and cannot be changed.”
The signed case becomes an E2B(R3) report built from the case fields, is checked against FDA and EMA rules — 0 errors, 0 warnings — and is queued for submission to the FDA gateway and EudraVigilance, due Oct 21. Dana is told; she sends it and files the acknowledgement.
A home-care nurse’s email about an 83-year-old man who felt dizzy and fell on Talmirex looks like CI-26-04790, which his son reported through the call centre: same age, product and event date, match 0.91. The nurse adds one new fact — no fracture, a bruised hip. Sam decides whether to merge it as follow-up information.
The duplicate detector never merges on its own — a person decides.
1,428 reports in 30 days from five channels, 62 of 62 serious cases inside their clock, and the agent time per step. Events by body system show liver events up from 1 % to 3 % — with a link straight to CI-26-04817.
The same morning, seen by the four people who carry a case from the inbox to the regulator.
Six specialist agents read, check, code and draft every report; a safety physician confirms and signs.
Reads emails, attachments, web forms, partner messages, call notes and articles in any language and pulls out every fact with its source sentence. Non-English text is translated and the original kept.
Checks the four minimum criteria — identifiable reporter, patient, suspect product and event — and sets Day 0. If one is missing, it drafts a follow-up request.
Compares each new report with existing cases by patient, product, event and dates, scores each candidate and explains the match. Above 0.85 it sends the report to the case processor.
Codes events, indications and history to the most specific MedDRA lowest level term, with its preferred term and system organ class; your products to the product dictionary and other medicines to the drug dictionary.
Applies the six seriousness criteria, compares each event with the reference safety information, flags potential Hy’s Law cases and starts the 7-, 15- or 90-day clock.
Drafts the case narrative in the house style and order, using only facts in the case and citing the source of every sentence.
Confirms and signs. The agents propose; a named person decides.
The safety team can ask about a case, a clock or a rule in plain words — or tell it what to change. Every answer points to where it comes from.
Why is the Veltrimab liver case a potential Hy's Law case?
In CI-26-04817 the lab report shows ALT 412 U/L — 10.3 × the upper limit — with total bilirubin 3.9 mg/dL, 3.3 × the upper limit. Alkaline phosphatase is only 1.2 × the upper limit, so the pattern is hepatocellular, and viral hepatitis and bile-duct blockage were excluded. That meets the potential Hy's Law criteria.
Is the liver injury expected?
No. The Veltrimab core data sheet (version 7.0) says no hepatobiliary adverse reactions have been identified, so drug-induced liver injury is unexpected. Fatigue is listed, but the case is assessed on its most serious event. Serious and unexpected means a 15-day report, due Oct 21.
Send every liver case to Lena Ortiz for a second look
Done. New routing rule: cases with an event in the MedDRA query “Drug related hepatic disorders” go to Lena Ortiz for a second physician review before signing. One open case matches today: CI-26-04817. The rule is live in Settings and recorded in the audit trail.
Draft a follow-up email to the pharmacist
To Priya Raman, PharmD: thank you for your report. To complete our assessment, could you tell us the patient's medical history, including liver disease; her alcohol use; the date the tiredness began; any herbal or over-the-counter products; and the latest liver test results. Saved as a draft on CI-26-04817 for you to send.
13 screens from the working solution, on its sample data. Pick one to see it large.
Clocks, sign-off and routing are settings your safety team owns.
| Setting | Default | Choose from |
|---|---|---|
| Fatal or life-threatening, unexpected — clinical study cases (SUSARs) | 7 days | 7 · 15 days |
| Serious, unexpected | 15 days | 15 · 7 days |
| Non-serious | 90 days | 90 days · Periodic only |
| Remind the case owner and submissions lead before due | 5, 3 and 1 day before | 5, 3 and 1 day before · 3 and 1 day before |
| Seriousness, expectedness and causality signed by | Dr. Maya Chen | Dr. Maya Chen · Lena Ortiz · Any safety physician |
| Downgrading a serious case needs a second physician | Lena Ortiz | Lena Ortiz · Dr. Maya Chen |
| Merging possible duplicates | Sam Patel | Sam Patel · Dana Okafor |
| Uncited fields block signing | 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 safety data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published rules and figures (21 CFR 314.80 and ICH E2D — the 15-day report for serious, unexpected cases). People, products and cases named on this page are characters and sample data in the working solution.
Software that takes a side-effect report from whichever channel it arrives by and turns it into an individual case safety report (ICSR): checked for validity, checked for duplicates, coded, assessed and written up for medical review. Case Intake does those steps with six agents and leaves the confirmation and signature to a safety physician.
The validity checker looks for the four minimum criteria — an identifiable reporter, patient, suspect product and event. Day 0 is the date the company first had all four, and it can only move earlier, never later. If something is missing it drafts a follow-up request, and the report has no clock until the reply makes it valid.
Yes. The coder codes each reported term to the most specific MedDRA lowest level term and shows the preferred term and system organ class; your products are coded to the product dictionary and other medicines to the drug dictionary. The verbatim term stays next to every code, and low-confidence codes are flagged for review.
The duplicate detector compares each new report with existing cases by patient, product, event and dates, scores each candidate and explains the match. Above 0.85 it goes to the case processor, who decides whether to merge it as follow-up information. It never merges on its own.
No. The assessor proposes seriousness and expectedness against your reference safety information and cannot downgrade a serious case. Causality is the physician’s: the solution may suggest one, but the narrative carries no causality opinion and a safety physician confirms everything and signs.
Yes. Once a case is signed it is built as an E2B(R3) report from the case fields, checked against FDA and EMA rules and queued for the submissions lead, who sends it to the FDA gateway and EudraVigilance and files the acknowledgement on the case.
Your Drug Safety mailbox and attachments, patient and HCP web forms, licensing partner E2B(R3) feeds, call-centre notes and a scheduled literature search — in any format and any language, with the original kept beside any translation.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your case processing procedure, narrative style guide, reference safety information and product dictionary — and it goes live once every quality gate has passed. We will walk you through it on your own past reports first.
Every journal article screened with a written reason, and reportable cases at intake in about a day.
1-min filmSignal ManagementEvery potential safety signal gets its evidence assembled in days, each number traced to its query.
1-min filmPeriodic Safety ReportsEvery periodic safety report is fully drafted within two weeks of data lock, each number traced to its query.
1-min filmWe’ll run Case Intake on a sample of your own past reports.