The same engine, from first-in-human through postmarket.
Safety surveillance is permanent, regulation-mandated work, and it doesn’t stop at approval. The engine that grades your trial adverse events processes your 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 your postmarket reports, so the evidence behind a signal reads the 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.
Your follow-up obligations run as long as 15 years, and Healthnotes captures between-visit signals for the whole of it.
First infusion
Graded and attributed at the encounter, on trial.
Approval
The signed record becomes the label’s evidence base.
Postmarket
Spontaneous reports run through the same engine, structured on arrival.
Year 15
Between-visit signals still land in the same record, still cited.
One unbroken record. The same engine, the same criteria and the same audit trail, from the first infusion to the last year of follow-up.