Signal reviews, inspection-ready.

Comprehensive adverse event analysis, designed for routine use by pharmacovigilance teams. Emerging risks flagged for review and documented, with PRR and ROR in minutes.

Built on KIRHA Search over safety and literature sources.

  • SOC 2 Type I
  • ISO 27001
  • HIPAA / HDS
EudraVigilance substance indexTeduglutide

Query controlled sources in their native grammar. Never the open web.

FDA FAERSEMAPubMedANSMHASClinicalTrials.gov

Adverse event reports, fully automated.

Designed by you, managed by a dedicated agent. Adverse event variances monitored across your product portfolio, on the cadence you set, with a summary of the main deviations.

The agent prompt with a single product named, Orgovyx.

Signal detection you can defend in an inspection

Portfolio-wide screening in minutes, without loosening control. The audit trail builds itself as the analysis runs, with no reconstruction needed before the next inspection.

Official

Straight from the regulators

FDA FAERS, EudraVigilance and the published literature, queried directly. No third-party aggregation.

Auditable

Every figure sourced

Each PRR, ROR and flagged signal resolves back to the individual case reports behind it.

Supervised

Your sign-off, always

Signals are flagged for review and reports pre-filled. Your team decide what is escalated.

More questions? More answers

Short answer: it isn't one. Detection engines give you a list of flagged combinations. What happens next is that an analyst opens each one, decides most of them aren't worth pursuing, and moves on. That's where the hours go, and it leaves almost no record behind. That's the part we work on.

Start with a strategic product from your portolio.

Tell us about your workflow and compliance constraints. We'll get back to you within one business day.

  • SOC 2 Type I
  • ISO 27001
  • HIPAA / HDS

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