SDEA management with agents: every obligation cited to its clause, every exchange on its own clock
Every partner safety agreement read into cited obligations, and every exchange watched against its own clock.
See one case, screen by screen ↓A safety data exchange agreement says who sends what to whom, by when: fatal cases in 4 calendar days, other serious cases in 7, line listings by the 10th, sales and exposure data 30 days after the data-lock point. Day 0 is the first receipt by either party, its affiliates or its contractors — so a partner’s late forwarding quietly eats into your own 15-day expedited clock.
Those clocks live in PDFs. Each partner has its own, a clause can disagree with its own appendix, a new licence can leave pregnancy reporting blank, and an acquisition can hand you nine more agreements that still name the old company as the party. By hand, reading one agreement into a register takes about six days by our estimate, and checking that every case, listing and reconciliation happened on time is a spreadsheet kept by hand.
Estimated split for reading one new SDEA into confirmed obligations, by hand and with the solution.
Specialist agents read each agreement, check it against the playbook, watch every exchange and match each reconciliation; the PV agreements manager confirms and decides.
Halvorsen Pharma’s fatal case reaches Northwind two days after its SDEA clock ran out, and a 46-page Norrland licence has just arrived from the contract system. Here is how both are handled, screen by screen, in the working solution.
Lena opens the solution to 18 safety agreements and 119 obligations watched. 97.7 % of exchanges were on time in the last 30 days against a 98 % target, 7 clocks are running and 3 end within 24 hours. Two late exchanges wait for her: a fatal case from Halvorsen Pharma and an SAE follow-up from Sorrel Clinical.
“Halvorsen Pharma · HV-26-08813” · “Fatal case 2 days late · Sudden cardiac death”
HV-26-08813, a sudden cardiac death in Denmark on Corventa. Day 0 was Thu Oct 1, when Halvorsen’s affiliate first received it; §4.1 of SDEA-014 gives 4 calendar days, so it was due Mon Oct 5. It arrived Wed Oct 7 at 06:12. On the same timeline: Northwind’s own 15-day reports to FDA and EudraVigilance, due Oct 16.
“Day 0 comes from the source document, never from our receipt date.”
The case is matched to SDEA-014 for Corventa in the EU and UK and marked 2 days late. The downstream check finds 9 days left on the 15-day reports and tells Sam Patel in case processing. The history check finds it is Halvorsen’s second late fatal or life-threatening case this year, after Mar 12. Beside it sit the sources: §4.1, the Day 0 definition in §2.3, the gateway log with a sender receipt date of 2026-10-01, and Halvorsen’s cover email.
Halvorsen’s email: “Our Danish affiliate received the report from a hospital physician on 1 October; it was entered into our local system on 6 October after a backlog during the system upgrade.”
The recommended option is to log a partner deviation and send a notice: Day 0 is not in dispute, because Halvorsen’s own email confirms Oct 1. The other option, accept with no deviation, applies only if Day 0 is disputed or Northwind caused the delay, and needs a reason. Lena keeps the three follow-ups ticked: ask for a CAPA plan within 30 days under §10.2, add the case to the Oct 21 joint safety committee, and confirm to case processing that the 15-day clock started Oct 1.
“Agents propose; your name goes on the decision.”
The Notice Writer drafts the letter from §4.1, the gateway log and Halvorsen’s own words, then a citation check confirms every fact is cited and checks the tone. The letter states the clock, the dates, the 2-day delay and Halvorsen’s explanation, confirms the 15-day reports are on track for 16 October, and asks for a CAPA plan by 6 November 2026. Lena can edit it; the citations stay attached.
Lena signs and sends. The exchange moves to Decided: partner deviation logged, notice sent to Halvorsen Pharma, CAPA response due Nov 6, on the Oct 21 joint safety committee agenda. The decision and the CAPA request are recorded in the audit trail.
SDEA-033: Norrland Pharma’s licence for Talmirex in the Nordics and Baltics, 46 pages, signed Sep 30 and effective Nov 1. It must be read and confirmed before the first case can arrive. One button starts the agents.
“Five agents read every clause and appendix, write each obligation with its clause and page, check it against the Northwind SDEA playbook and against the agreement itself.”
The Agreement Reader splits the 46 pages into 12 sections and an appendix. The Obligation Extractor writes 14 obligations, each with its clause and page, and the clock check sets Day 0 as first receipt by either party (§2.3), in calendar days. On the document, §4.2 lights up red and §4.4 reads “[Intentionally left blank.]”
§4.2 says 5 calendar days for other serious cases; Appendix 2 says 7. The recommendation is the stricter 5 days, since the clause governs over the summary table, and to ask Norrland to correct Appendix 2. §4.4 is left blank, so pregnancy and special situations are not covered: the recommendation is to apply the playbook’s 30 calendar days in the meantime and ask Omar Haddad to add §4.4 in an amendment before Nov 1. Reconciliation is quarterly where the playbook expects monthly; the recommendation is to accept quarterly for the first year, at about 20 cases a month.
The Playbook Checker recommends; it never decides.
With all three questions resolved by Lena, 15 obligations are ready — the pregnancy rule added on its interim playbook clock. Lena signs with the meaning “I confirm these obligations reflect the signed agreement”. The PSMF contracts list is updated, the QPPV is told, and the Exchange Monitor watches every obligation from the effective date, Nov 1, 2026.
The same agreements, seen by the five people who carry them — what their month looked like, and what it looks like now.
Specialist agents read each agreement, check it against the playbook, watch every exchange and match each reconciliation; the PV agreements manager confirms and decides.
Splits each safety agreement into numbered clauses, appendices and tables, and tells signed versions from drafts.
Turns clauses into obligations — who sends what to whom, by when, in what format, with the Day 0 rule — each cited to its clause and page.
Compares each agreement with the SDEA playbook and with itself — clause against appendix — and raises conflicts and gaps.
Watches the partner gateway, mailboxes and the safety database, matches every exchange to its agreement and runs its clock from Day 0.
Matches a partner’s line listing against the safety database — by reference, then stored partner reference, then patient, event and dates — and explains every row left over.
Drafts partner notices, CAPA requests and governance-meeting items, citing the clause, the log and the partner’s own words.
Confirms obligations, decides late exchanges. The agents propose; a named person decides.
Ask about any partner, agreement, clock or reconciliation — or tell it what to change. Answers cite the clause they rest on.
Which partners were late this month?
In the last 30 days 47 of 2,031 exchanges were late (97.7 % on time). Two still need your decision: HV-26-08813 from Halvorsen, 2 days late, and SRL-302-0119 from Sorrel, 1 day late. The fatal case from Halvorsen breaks §4.1 — 4 calendar days from Day 0 — and their own email confirms Day 0 was Oct 1.
What does Halvorsen owe us for the Corventa PBRER?
Halvorsen provides sales, exposure and local safety data within 30 calendar days after each data-lock point. The next Corventa PBRER locks on Oct 31, so their data is due Nov 30. In return we tell them about validated signals within 3 business days — the hepatic signal went out on Oct 6, on time.
How much of our own 15-day clock is left?
Halvorsen’s delay used 6 days of our 15. Our reports for NW-26-40241 run from Day 0, Oct 1, so FDA and EudraVigilance reports are due Oct 16 — 9 days left. Sam Patel was told this morning; medical review is in progress.
Add a rule: alert 24 hours before any fatal case clock ends
Done. The Exchange Monitor now alerts you and the partner 24 hours before any fatal or life-threatening case clock ends — across all 9 agreements that exchange cases, using each one’s own clock (3 days for Kestrel, 4 for Halvorsen). The rule is on in Settings and in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
Clocks, approvers and the playbook the agents check every agreement against are settings — fatal cases in 4 calendar days or less, serious in 7 or less, E2B(R3), monthly reconciliation, pregnancy covered, data handed over within 30 days of termination.
| Setting | Default | Choose from |
|---|---|---|
| Warn before a clock ends | 24 hours | 12 · 24 · 48 hours |
| Day 0 when an agreement is silent | First receipt by either party (playbook) | First receipt by either party · Receipt by Northwind |
| Business days follow | Each partner’s country calendar | Each partner’s country calendar · Northwind US calendar |
| Tell case processing when a partner delay uses more than 5 days of the 15-day clock | On | On · Off |
| Confirm extracted obligations | Lena Ortiz | Lena Ortiz · Dana Okafor |
| Decide late exchanges and send notices | Lena Ortiz | Lena Ortiz · Omar Haddad |
| Sign reconciliations | Lena Ortiz | Lena Ortiz · Sam Patel |
| Approve the PSMF contracts list | Dr. Maya Chen | Dr. Maya Chen · Dana Okafor |
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 partner data · “target” = the design goal, measured in the live solution · “estimated” = our estimate, including the by-hand time to read an agreement. Context: EU Regulation 520/2012 Art. 25 · GVP Modules I and II · 21 CFR 314.80. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that turns each safety data exchange agreement into the obligations it creates — who sends which cases, listings and reports to whom, by when — and then checks that each exchange happens on time. The SDEA Obligation Tracker adds agents that read the agreements, check them against your playbook, watch every exchange and reconcile every line listing.
The Agreement Reader splits the agreement into clauses, appendices and tables. The Obligation Extractor writes each obligation with sender, receiver, clock, Day 0 rule and format, cited to its clause and page. The Playbook Checker compares it with your playbook and with its own appendix, and raises conflicts and gaps for the PV agreements manager to resolve before confirming.
From Day 0 as the agreement defines it — usually the first receipt of a valid case by either party, its affiliates or its contractors. The Exchange Monitor reads Day 0 from the partner’s own message, never from your receipt date, and shows how much of your own 15-day expedited clock is left.
The exchange is marked late and sent to the PV agreements manager with the clause, the logs and the partner’s explanation. She chooses to log a partner deviation and send a notice, or accept it with a reason. The Notice Writer drafts the letter with citations; a person signs and sends it.
Yes. The Reconciliation Matcher matches each partner listing against your safety database by reference, stored partner reference, then patient, event and dates, and explains every row left over as the same case, a timing difference at the cut-off, or a missed exchange. A missed serious case is always raised to a person, and the reconciliation is signed.
Yes. Inherited agreements are read by the same agents, and the questions they raise include agreements that still name the acquired company as the party and partners still sending CIOMS forms by email, with the date their cases move to your database.
Yes. The agents read, extract, check, match and draft; only the PV agreements manager confirms an agreement, decides a late exchange or sends a notice, and approvers are settings. Every read, decision and signature is kept in the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements — your SDEA playbook, your agreements and a sample of partner exchanges and line listings — and it goes live once every quality gate has passed. We will walk you through it on your own agreements first.
Every side-effect report becomes a cited case in minutes, filed with days to spare.
1-min filmSafety LiteratureEvery 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 filmWe’ll run the SDEA Obligation Tracker on a sample of your own safety agreements and partner exchanges.