PSP adverse event reporting, with every hub and nurse conversation read in full
Every patient-programme call, email, chat and note is read in full, and each side effect reaches safety inside the 24-hour window.
See one case, screen by screen ↓A patient calls the hub about a declined copay card. Two minutes in she mentions the pen did not work; a minute after that, that her lips swelled up and she went to urgent care. The coordinator logs the pen complaint, sends a return kit and gets back to the bridge enrolment. The reaction never reaches a safety form.
Oversight today means a person listening to a small sample of calls, and the rest of the record — emails, web chats, texts, nurse visit notes, case notes written as re-enrolment comments — is trusted to the vendor’s own log. What the vendor did not log turns up later in reconciliation, or by an inspector, long after the 24-hour forwarding window in the safety data exchange agreement has closed.
Estimated split in hours for one potential case that the vendor does log, by hand and with the solution. A case the vendor never logs does not reach this clock at all.
Six specialist agents screen every conversation, check, pre-fill and time each potential case, and reconcile the vendors each month; the PV intake lead decides each case.
At 15:42 on Oct 6 a patient calls Veltrimab Together about her copay card. The vendor logs a pen complaint. Here is what happens next, screen by screen, in the working solution.
Lena opens Hub pulse: 3,412 interactions screened in 24 hours across Veltrimab Together, Corventa Assist and Talmirex Start, run by Harborline Hub Services and BlueOak Nurse Partners. 71 potential cases found, 46 already sent inside the window, 10 waiting for her — three due in under six hours. The clock wall lists them by time left; F-1047 has 5 h 22 m.
“Caught where the vendor form was silent — 6 in 24 hours · each would have been an inspection finding.”
F-1047 is a 6 min 48 s copay card call with Sam Patel, a Harborline care coordinator, aligned to the audio. The screener marked two findings at 15:49 with confidence 96: the pen that “clicked but the window never turned yellow” at 01:52, and the hives and lip swelling at 03:04, after the pen complaint was logged. The four-element checker finds an identifiable reporter (the patient herself), patient R.M., female, 41, Veltrimab 150 mg pen lot VX24117B, and the event: a valid case, solicited report from a patient support programme.
“Since the last two shots I get hives on my arms, really itchy, for a day or two. And Saturday my lips swelled up.”
The Harborline form reads: product complaint, pen did not deliver the full dose, lot VX24117B, replacement pen and return kit sent. Adverse event: none recorded. Next to it, the two findings from the conversation. The difference is flagged for the monthly reconciliation and the vendor’s coaching signals, and a coaching note for the vendor can be drafted from here.
“The coordinator logged the pen complaint but not the hives and lip swelling the caller described a minute later.”
Eighteen fields are filled before Lena opens the tab: report type “Solicited — patient support programme (Veltrimab Together)”, day 0 Oct 6, 2026 15:42 — the call, the reporter as a consumer who can be contacted, the prescriber Dr. Alvarez from the hub case, product and lot. Each field carries a confidence and a number that plays the words it came from; a click on a value corrects it.
Hives codes to Urticaria (PT), LLT Hives. The lip swelling codes to Lip swelling (PT), with Angioedema (PT) queried for the physician. Treatment at urgent care with an antihistamine and a steroid injection, resolved by Sunday Oct 4, next dose due Friday Oct 9. Seriousness: possibly serious — possible angioedema, an important medical event. The product complaint is linked as PQC-26-0912, and the duplicate check finds no match over 90 days.
Possibly serious goes to a safety physician — the final call on seriousness is Dr. Maya Chen’s.
Lena confirms it as a valid case, solicited report. Three routes are on by default: send to Dr. Maya Chen for seriousness, expectedness and causality; send the complaint to Quality, to Dana Okafor, linked to this case; and send the reference back to Harborline so the vendor log and the safety database match. Her signature records its meaning.
“Signing as Lena Ortiz · meaning: I confirm this is a valid case from a patient support programme · Oct 7 10:20.”
The case is created in the safety database as solicited, SDB-2026-118343, with a review task for Dr. Maya Chen. The complaint splitter sends PQC-26-0912 with lot VX24117B to Quality. The clock stops at 18 h 38 m from day 0, inside the 24-hour window, and every step — the screener at 15:49, Lena’s confirmation at 10:20 — sits on the case’s activity, people and agents, immutable.
F-1046 is a Harborline case note from Oct 2: the patient’s husband said she was in hospital five days with pneumonia, and her doctor stopped Corventa. It sat in the hub case system as a re-enrolment comment. The screen found it at 03:10 today, in the 30-day look-back after case notes were connected on Oct 6. Hospitalisation makes it serious; day 0 is Oct 2, so confirming it needs a late reason, and a deviation is opened for vendor oversight.
A late case needs a reason — required by the quality system, it cannot be turned off.
October to date: 333 records on the vendor logs, 344 cases confirmed by PV intake, 342 in the safety database, 38 of 41 complaints in the quality system. 14 were found by the screen and never on the vendor log. Every difference has an owner and closes only with a reason. Coaching signals show the patterns behind them — Coordinator H-27, “events mentioned after the reimbursement topic is closed”, 9 of 212 not logged.
A person reviews a random 1 % of the interactions the screen marked clean, to show how often it misses something. Oct 6: 34 drawn from 3,341 clean interactions, 22 reviewed, 0 missed. In September, 991 reviewed and 1 missed — “my throat felt tight” — now one of the screen’s examples.
The same call, seen by the people who carry it — what their week looked like, and what it looks like now.
Six specialist agents screen every conversation, check, pre-fill and time each potential case, and reconcile the vendors each month; the PV intake lead decides each case.
Reads every call transcript, email, chat, text and note from the hub and nurse vendors and marks each passage about an adverse event, a special situation or a product problem, with the exact words and the time or line.
Finds the identifiable reporter, patient, suspect product and event for each passage, each with the words that support it, and says whether the case is valid.
Fills the safety intake form — reporter, patient, product and lot, verbatim, MedDRA terms, onset, treatment, outcome, action taken, seriousness — and checks the safety database for duplicates over 90 days.
Separates product quality complaints, captures lot number and device description and whether the item can be returned, and links each complaint to any adverse event in the same contact.
Sets day 0 for every potential case, counts down the forwarding window, warns as it closes, and asks for a reason when a case is late.
Each month lines up the vendor logs, confirmed cases, the safety database and the quality system, explains each difference, and draws a random sample of clean interactions for a person to check.
Decides each case. The agents propose; a named person decides.
Ask in plain words, or tell it what to change. Every answer shows the exact words behind it.
What is due in the next 6 hours?
Three potential cases, one already late: F-1046, hospital stay for pneumonia — late; F-1041, fainted after the first self-injection — 3 h 10 m; F-1047, pen did not inject, hives and lip swelling — 5 h 22 m. Start with F-1046 — serious and already late, it needs a late reason.
Why is F-1047 possibly serious?
Because the caller describes lip swelling — “Saturday my lips swelled up” — after hives with the last two doses, and she was treated at urgent care with an antihistamine and a steroid injection. With hives after a dose it may be angioedema, which is on the important medical event list. She was not hospitalised and it resolved by Sunday, so the final call on seriousness is Dr. Maya Chen’s. Her next dose is due Friday — worth a follow-up before then.
What did the vendors not log in the last 24 hours?
Six, where the vendor form left out what the conversation said — among them F-1047 (form: product complaint only; call: hives, then lip swelling treated at urgent care), F-1046 (nothing logged; five-day hospital stay for pneumonia) and F-1051 (cancellation only; death on Sep 28, cause not stated). Each goes into this month’s reconciliation and the vendor coaching signals.
Flag every urgent care or emergency visit as possibly serious
New rule: any urgent care, emergency room or walk-in clinic visit makes a potential case possibly serious and routes it to a safety physician. Re-checking September, 3 cases sent as non-serious mention an emergency visit; they are on Dr. Maya Chen’s review list. The rule waits for Omar Haddad’s approval and is recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
What the screen flags, the clocks and who decides are settings, set to your safety data exchange agreements.
| Setting | Default | Choose from |
|---|---|---|
| Forwarding window | 24 hours | 24 hours · 1 business day |
| Warn me when | 6 h left | 6 h · 4 h · 2 h left |
| Day 0 for nurse visit notes | Visit time | Visit time · Note time |
| Sensitivity | Balanced | Broad · Balanced · Strict |
| What the screen flags | Adverse events always on | Product complaints · pregnancy and breastfeeding · medication errors and overdose · lack of effect · off-label use · missed doses with no event |
| Confirms cases | Lena Ortiz · PV intake lead | Lena Ortiz · Dr. Maya Chen · Omar Haddad · Dana Okafor |
| Possibly serious and serious | Dr. Maya Chen · safety physician | Lena Ortiz · Dr. Maya Chen · Omar Haddad · Dana Okafor |
| Rules | Approved, each with a version | Add a rule in plain words |
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 programme data · “target” = the design goal, measured in the live solution · “estimated” = our estimate; the 2–3 % call sample is common oversight practice · GVP Module VI (EMA) is named as context. People, programmes, products and vendors named on this page are characters in the working solution.
Reading every interaction a hub or nurse vendor has with patients, caregivers and health professionals — calls, emails, chats, texts, visit notes and case notes — for adverse events, special situations and product complaints. The PSP Safety Signal Catcher marks each passage with its exact words, checks the four minimum elements, pre-fills the safety intake form and counts down the forwarding window.
Solicited. GVP Module VI treats safety reports from patient support programmes as solicited reports, and every confirmed case here is sent as solicited with the programme name — for example “Solicited — patient support programme (Veltrimab Together)”.
Day 0 is the first time anyone at the vendor or the company had the four minimum elements — the call, the visit or the email, not the time a form was typed. For a nurse visit at 13:30 written up at 17:50, day 0 is 13:30.
No. The agents mark, check and pre-fill; the PV intake lead confirms each case or closes it as not a case with a reason, and possibly serious and serious cases go to a safety physician for seriousness, expectedness and causality. Every decision is on the activity trail.
The complaint splitter separates each product complaint, captures the lot number, the device description and whether the item can be returned, and sends it to Quality — always linked to any adverse event from the same contact.
A person reviews a random 1 % of the interactions the screen marked clean. In September, 991 were reviewed and 1 was missed — “my throat felt tight” — which became one of the screen’s examples. Sensitivity is a setting: Broad, Balanced or Strict.
Yes. Each month the reconciliation agent lines up the vendor logs, confirmed cases, the safety database and the quality system, gives every difference a reason and an owner, and shows coaching signals — patterns of unlogged events per vendor staff member, with no patient data.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your safety data exchange agreements, intake form and a sample of programme interactions — and it goes live once every quality gate has passed. We will walk you through it on your own calls and notes first.
Every faxed or portal enrollment form becomes a cited patient-support case in minutes, the same day it arrives.
1-min filmPrior AuthorizationEvery request reaches the payer with each criterion proven from the chart, so patients start treatment in days.
1-min filmPatient AssistanceEvery free-medicine application is checked against every rule, each figure cited, and most are decided within a day.
1-min filmWe’ll run the PSP Safety Signal Catcher on a sample of your own programme calls, emails and notes.