The same engine, from first-in-human through postmarket.
Safety surveillance is permanent, regulation-mandated work. The engine that grades trial adverse events processes postmarket reports with the same citations and the same attribution algorithms.
CTCAE v6.0 · 10002272
same citation as the trial
CASE-2026-0147 · postmarket report
Safety narrative, drafted
Ready to editgraded · attributed · cited
IND → POSTMARKET
One engine
intake · structured at capture · same engine as the trial
the narrative starts itself
One engine carries the drug through its whole life.
The same engine processes postmarket adverse events and produces submission-ready safety narratives.
The label is a living document.
Postmarket signal detection is where an incomplete trial-phase adverse event profile becomes a label revision. The same engine, the same criteria and the same attribution algorithms run on postmarket reports, so the evidence behind a signal reads the same way it did in the trial.
Postmarket volume arrives already structured.
FAERS receives on the order of two million adverse event reports a year; structure at intake is what makes that volume workable.
Source: FDA FAERS public dashboard.
Your submission arrives ready to send.
Graded, attributed, cited events become safety narratives your team edits, already assembled.
Gene therapy follow-up runs for fifteen years, and so does the record.
Follow-up obligations run as long as 15 years; Healthnotes captures between-visit signals for the duration.