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.

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.

Yes, on whatever data you've given us access to. Though if you already have an engine you trust, keep it. We're not trying to displace Empirica, and most of what we're useful for happens once the numbers already exist.

No, and no. It doesn't process cases and it doesn't submit anything. On the agents: they're being built for the data already sitting inside those platforms, which is genuinely useful if all your work happens in one of them. It usually doesn't. A team screening across Argus, LifeSphere and Vault ends up running three processes and keeping three sets of records.

EU hosting, GDPR. FAERS is public and we query it directly. EudraVigilance is different. The data on your products sits in EVDAS, where access is given to named individuals whose roles your QPPV approves and can withdraw at any time. It runs on your registration, never ours. EVDAS has no API and the reaction monitoring report is produced once a month, so what we work from is an export on your schedule. There's no live connection and we don't claim one.

There is also a public EudraVigilance dataset on adrreports.eu. Anyone can query it, us included. It leaves out case narratives and truncates the patient fields, which makes it useful for comparators and class effects and not much else. If a vendor tells you they query EudraVigilance, ask which of the two they mean.

Which sources make sense depends on your products and your markets. We agree the list with you before anything runs.

Validating and documenting model performance is the marketing authorisation holder's obligation, not ours. We can't take it off you and shouldn't pretend to. What we can do is make it workable: pinned versions, a log of every run, the ability to re-run a past scope and diff the output, and a validation package your QA gets before they think to ask for it. The agent prepares the material. Your people make the call and sign it.

We don't have a measured number for this yet, and neither does anyone else. Nobody publishes one for this specific task. We're not going to borrow a figure from a study on something adjacent and present it as ours. Run the evaluation and you get a number on your own data. We'll publish what comes out of it, including if it's disappointing.

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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