A safety signal is information suggesting a new, potentially causal association between a drug and an event, or a new aspect of a known one, that warrants further evaluation. The discipline of signal detection is about catching that information early, from noisy data.
Where signals come from
Spontaneous report databases (FAERS and others), literature, clinical and epidemiological data. Each is a different vantage point on the same underlying safety reality.
Quantitative and qualitative together
Disproportionality methods flag statistically unusual reporting; clinical judgement decides whether it matters. Neither works alone, a number without a narrative is not a signal.
See it sooner
The practical bottleneck is usually visibility and freshness. Single-drug visual analysis on current data lets analysts notice a rising reaction before the next periodic review, while literature surveillance catches the published side.
How Ichelon helps
Pharos Vigil handles the adverse-event visualisation; Pharos Scout handles literature surveillance, together giving safety teams an earlier, clearer line of sight on emerging signals.
Ready to apply this thinking?
Start a pilot project and evaluate Ichelon's quality within one delivery cycle.