Call note compliance screening — every note read in full, and every possible side effect sent to Drug Safety on a clock that runs from the call
Every call note is read in full the night it is filed, so possible side effects reach Safety in hours.
See one case, screen by screen ↓A physician mentions, between clinics, that a patient broke out in hives and her lips swelled after the second injection. The rep writes it into the call note the next morning, along with an off-label question, a remark about a payer and a line about the competitor. Under the company SOP, Drug Safety must have it within one business day — and Day 0 is the day the rep heard it, not the day the note was filed.
Today most of those notes are never read by a person. Compliance samples about one in twenty by hand, weeks after the call, and a keyword list does the rest: it misses an event told in plain words and raises a false alarm on “pediatric” in a practice name. Unsolicited requests can sit in free text, absolute and comparative claims can go uncoached, and what physicians say about access and objections never reaches the teams that could use it.
Estimated split for a possible adverse event told on a call, in hours — with sampled review by hand, and with the solution.
Specialist agents read every note, screen it for safety, label use and insights, route it and ask the rep for missing facts; the field compliance lead decides each route.
On Tuesday at 14:20, Dr. Elena Ruiz tells Sam Patel about a patient who reacted to her second Veltrimab dose. Sam dictates his note the next morning. Here is what happens next, screen by screen, in the working solution.
Lena opens Today: 1,284 of 1,284 call notes screened overnight, from 612 reps. Fifteen findings need her decision — 6 safety, 4 medical information, 5 language — on 10 notes. Five safety clocks are running; the next, a jammed pen, runs out in 25 minutes. 486 field insights were captured from yesterday’s calls.
“Before: about 5% of notes sampled by hand, read 2–6 weeks after the call (estimated) — ≈ 64 of 1,284 notes would have been read.”
CN-40817 — Sam Patel to Dr. Elena Ruiz, dermatology, Denver — is a 1:48 voice note with a possible adverse event, an off-label request, a language flag and 4 insights. It has 4 h 15 m left, due Oct 7 at 14:20, exactly one business day after the call. Turned on, the old keyword list column shows what it would have done: missed the hives and lip swelling, and flagged “pediatric” in the practice name.
Day 0 is the call, not the filing · due 1 business day later.
The note opens with Sam’s words, transcribed and split into 11 sentences, each finding marked where it was said. The safety referral is already drafted — hives and lip swelling after the second Veltrimab dose, urgent care, confidence 97% — with all four ICH E2D minimum criteria found in the text: a woman in her forties, Dr. Ruiz as reporter, Veltrimab 150 mg dose 2, and the event. Onset, treatment, outcome and the held next dose are filled in from the note.
“Lip swelling may be angioedema — medically important, so Safety should assess seriousness.”
Lena presses Re-screen to see the work. The Note Reader transcribes the voice note and matches Dr. Ruiz to the physician master. The Safety Signal Spotter finds the event; the Off-label & Language Checker finds one medical information request and one language issue against the label and the promotional standards; the Insight Extractor finds four de-identified insights; the Router & Clock Keeper proposes three routes, Safety due Wednesday 14:20.
“Each finding is tied back to the sentence it came from. Day 0 stays the call.”
Lena reads the cited sentences and sends the referral. It goes to Drug Safety as SR-26-11845, signed with her credentials and written to the audit trail; Drug Safety intake confirms receipt and the 02:00 reconciliation will match it to its case. For the facts still missing, the Rep Follow-up Writer has a question ready for Sam: the pen’s lot number and whether the patient was admitted.
Dr. Ruiz asked whether she could start Veltrimab in a 15-year-old who has failed two topicals. Veltrimab is approved for adults only, and the label passage is shown. The request is marked unsolicited, Sam’s handling — he declined and offered Medical Information — is checked as correct, and the reply goes by email, as agreed in the call. Lena sends it as MIR-26-3325; Omar Haddad answers in writing within 2 business days.
Sam told Dr. Ruiz that Veltrimab “clears skin faster than Zorelta”. There is no head-to-head study in the label or approved material, so the claim is flagged under the comparative-claims rule, with the approved alternative from the detail aid. It is Sam’s second language flag in 30 days. Lena chooses Coach the rep; the coaching goes to his district manager, Priya Raman, with the sentence, the rule and the approved line.
Approved alternative: “At Week 16, 74% of patients on Veltrimab achieved clear or almost clear skin, versus 6% on placebo.”
That morning, on his next visit, Sam dictates the note of his visit to Dr. Tessa Vaughn into the CRM. As he speaks, the agents read along: a man in his sixties with a painful red swelling two days after his first dose “sounds like a side effect — it will go to Drug Safety”, and “works for everyone” is an absolute claim, with the approved line from the detail aid offered in its place.
“Nudges on · nothing leaves the CRM until you submit.”
Sam takes the approved wording and submits. The note is screened at once: a possible adverse event with 4 of 4 minimum criteria, no language issue, one access insight about Bluetern Health. CN-40831 lands in Lena’s safety clocks 26 minutes after the call, with 23 h 34 m to spare.
The dashboard shows 27,940 call notes screened in 30 days, a median of 6.6 hours from the call to Safety, 251 safety referrals with 1 late, and 389 medical information requests. On the same notes the old keyword list caught 49 of the 196 possible adverse events and raised 1,212 false alarms; the agents raised 38. Language flags are at 17.2 per 1,000 notes and falling as reps see nudges.
The same note, seen by the five people it matters to — what their week looked like, and what it looks like now.
Specialist agents read every note, screen it for safety, label use and insights, route it and ask the rep for missing facts; the field compliance lead decides each route.
Transcribes voice notes, splits each note into sentences and matches products, physicians and practices — with the call date and time recorded as Day 0.
Finds possible adverse events told in plain words, pregnancy, lack of effect and product complaints, cites the sentence and checks the four ICH E2D minimum criteria.
Checks each note against the label’s approved uses, ages and doses and the promotional standards, and proposes the approved alternative for any wording it flags.
Turns notes into structured insight records — access barriers, objections, competitor mentions, product experience, unmet needs — with payer, sentiment, specialty and region.
Creates one referral per finding — to Drug Safety, Quality, Medical Information or Compliance — and sets each due time from the call.
Drafts one short CRM message to the rep for missing facts — age, sex, onset, lot number — and attaches the answer to the referral.
Decides each route. The agents propose; a named person decides.
The compliance lead can ask in plain words — or tell it what to change. Every answer points back to the sentence it rests on.
Which safety clocks run out today?
Five are running. The jammed pen in CN-40820 is first, with 25 minutes left — Derek filed it 11 hours after the call. Then the positive TB test (2 h 55 m), the hives and lip swelling after the second Veltrimab dose (4 h 15 m), the carton and pen expiry dates (5 h 5 m) and lack of effect after three Talmirex doses (6 h 40 m). Each clock runs from the call, not the filing.
Why did the keyword list miss CN-40817?
Because nothing in the sentence is on the list: “broke out in hives and her lips swelled up … went to urgent care”. The list flagged “pediatric” in the practice name, Aldervale Pediatric & Adult Dermatology, instead — a false alarm. The agents read meaning: a patient, a reporter, a product and an event, all four minimum criteria.
Add a rule: flag Veltrimab dosing other than every 12 weeks
Done. Any Veltrimab interval other than Week 0, Week 4 and every 12 weeks now raises a Medical Information request — like Dr. Kowalski’s 8-week question. The rule is on in Settings and recorded in the audit trail.
What are dermatologists saying about access?
Larkspur Health Plan: two biologics first, prior authorisation denied twice — 38 mentions. Regional Health Plan: re-authorisation at month 6 — 31. Harborline PBM: a 30-day supply limit — 27. Bluetern Health is the bright spot: a new PA form with 3-day approvals.
13 screens from the working solution, on its sample data. Pick one to see it large.
Routes, clocks and rules are settings. Every change is versioned and written to the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Day 0 for safety information | Call date | The date the rep heard it, including weekends |
| Forward to Drug Safety within | 1 business day | Same business day · 1 · 2 business days (longer than the SOP waits for Drug Safety’s approval) |
| Send automatically when all four minimum criteria are met | On — weekends and holidays | On · Off |
| Send automatically on weekdays too | Off — a person confirms each referral | On · Off |
| Ask the rep for missing facts | On | Age, sex, onset, lot number — sent from the CRM |
| What the agents look for | 7 of 8 on | Adverse events, complaints and off-label questions required · absolute language · comparative claims · beyond the label · unapproved use · gifts, meals and speaker talk |
| Nudge while the rep types or dictates | On | On · Off |
| Coaching goes to the district manager | On | With the sentence, the rule and the approved alternative |
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 call notes · “target” = the design goal, measured in the live solution · “estimated” = our estimate · ICH E2D minimum criteria and 21 CFR 314.80 are cited as context; the one-business-day rule is the working solution’s sample company SOP. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Reading the notes field reps file after each physician call for anything that must go elsewhere: possible adverse events and product complaints to Drug Safety, unsolicited off-label questions to Medical Information, and promotional language to compliance. Call Note Compliance & Insight Capture reads every note, typed or spoken, and also captures the field insights in it.
The Safety Signal Spotter reads meaning, not keywords, so “broke out in hives and her lips swelled up” is found even though no listed word appears. It cites the sentence and checks the four ICH E2D minimum criteria — patient, reporter, product and event. On the working solution’s sample data it found 196 possible adverse events in 30 days, where the keyword list caught 49.
On Day 0 — the date the rep heard it, the call date, including weekends — not the day the note was filed. The deadline to forward to Drug Safety is a setting; in the working solution it is one business day, the sample company’s SOP.
Only if you allow it. In the working solution a referral goes automatically on weekends and holidays when all four minimum criteria are met, so no one waits for Monday; on weekdays a person confirms each one. No agent ever closes a possible adverse event on its own.
Each unsolicited request becomes a Medical Information request with the physician’s question as it will read, whether it was asked unprompted, how the rep handled it and the reply channel agreed in the call. Medical Information answers in writing; the rep does not.
Yes. Absolute claims, comparisons without head-to-head evidence and statements beyond the label are flagged with the rule and the approved alternative from approved material. The compliance lead coaches, escalates or dismisses with a reason; coaching goes to the district manager. Reps can also see nudges while they type or dictate.
Yes. The agents propose every route; the field compliance lead decides each one — send, coach, escalate or dismiss — with her decision signed and written to the audit trail. Dismissals need a reason and Drug Safety takes a weekly second look.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your safety and medical SOPs, promotional standards, labels and a sample of past call notes — and it goes live once every quality gate has passed. We will walk you through it on your own call notes first.
The quarterly risk narrative, drafted in minutes with every figure from a live query.
1-min filmField PlaybooksEvery rep opens the right playbook for their market, built 70% faster.
1-min filmClaims ReviewEvery chargeback claim read first by agents, each verdict with its rule and evidence.
1-min filmWe’ll run Call Note Compliance on a sample of your own past call notes.