Pharmacovigilance
Aggregate reports, reconciled cycle over cycle.
The periodic reports run on a fixed calendar. Signal work does not. Two clocks, two applications.
The applications for pharmacovigilance.
Each one is a family of related work rather than a single workflow, built with the specialists who do it.
Aggregate Safety
PBRERs, PSURs, PADERs and DSURs
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.
See Aggregate Safety →
Signal Desk
Case narratives, literature screening and signal evaluation
Screening is continuous, the evidence is scattered, and the documentation is written after the decision. Narratives arrive written from the case record at volume, and the evaluation is documented as the work happens rather than six weeks later.
See Signal Desk →
What arrives.
The documents this function is judged on, authored from your own records and reviewed before your team opens them.
- PBRERs drafted against the safety database and checked against last period
- PSURs where the region still wants that format, PADERs for the US
- DSURs across the development programme
- Case narratives written from the case record, at volume
- Signal evaluation reports
- Risk management plans
- Literature screening with the documentation behind it
PBRER is ICH E2C(R2) and has largely replaced PSUR in the EU and UK. FDA accepts a PBRER in lieu of a PADER. CDSCO still wants PSURs for the first four years post-approval, which matters for the Indian portfolio.
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.