Aggregate SafetyPharmacovigilance
The reporting calendar doesn't negotiate.
The portfolio grows, the headcount doesn't, and every cycle somebody compares this report against the last one by hand. The PBRER arrives drafted against the safety database and reconciled to the prior cycle, differences already surfaced.
What it does.
Aggregate reports, drafted from the database.
PBRERs and PSURs authored against the safety database and your product record, to the current template.
Reconciled to the prior cycle.
What changed since the last report is surfaced with the data behind it, not hunted for by hand.
PADERs and DSURs.
Periodic and development safety reporting on the same engine, with the same reconciliation.
Aggregate reconciliation across products.
Counts and listings reconciled across the portfolio before the report goes out.
The rest of pharmacovigilance.
Start where it hurts.
We'll run it live on a section of your own work.
Request a demoYour data stays in your environment. Customer data never trains foundation models.