AI safety signal detection for pharmacovigilance
A safety signal is easy to see once someone has found it and hard to see while it is still forming. Axira signal detection reads across the sources a safety team already holds and raises the ones that warrant a scientist rather than burying them in a monthly report.
Reporting rates rarely move in an obvious way. A signal that would be dismissed as noise inside a single case series can be clear when the same pair appears in spontaneous reports, in literature, and in a biological pathway at the same time. Axira signal detection reads across those sources together and applies disproportionality analysis to the combined picture rather than to each source in isolation.
Every raised signal arrives with the reason it was raised. The system reports which sources contributed, how strongly each one weighed, and what threshold was crossed, so a safety scientist can accept the signal, reject it, or ask for a different threshold on evidence rather than on trust.
Case data, literature, and omics streams enter through the governed data layer, where provenance is recorded on the way in rather than reconstructed later. Reasoning runs through validated inference pipelines with human review retained at the decision point, and every output carries an attributable, timestamped record of the path that produced it.
That structure exists because the alternative does not survive contact with a regulated safety function. A signal a team cannot explain to an inspector is a signal a team cannot act on.
In January 2025 the FDA issued draft guidance on the use of artificial intelligence to support regulatory decision-making for drug and biological products, setting out a risk-based credibility assessment framework tied to a defined context of use. Post-marketing safety sits squarely inside that scope. A signal detection tool used to produce information supporting a regulatory decision has to be able to demonstrate its own credibility for that specific use, not in general.
Axira signal detection is designed against that expectation. The context of use is stated, the model risk is assessed, and the evidence supporting the output is assembled as the output is produced.
Released in sequence, filings in progress.
Axira modules are released one at a time rather than as a single launch, each as a minimum lovable product that is complete enough to run on real work. This capability is the subject of intellectual property filings in progress. Its published name and its technical architecture are withheld until those filings complete, and detail is shared under a non-disclosure agreement.
By application.
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