Signal detection during clinical development is fundamentally different from post-marketing pharmacovigilance, and it changes character as a program matures. A first-in-human study, a dose-finding trial, and a global pivotal study each present a distinct data reality, and each calls for a different detection method.

This white paper by Dr. Mohit Raizada presents a phase-appropriate framework spanning Phase I, II, and III, showing how signal detection progresses from intensive case-level medical surveillance, through structured trend and pattern recognition, to comparative benefit-risk assessment. It gives clinical safety and pharmacovigilance leaders a clear, side-by-side view of how objectives, statistical methods, governance, and escalation triggers should shift by phase, grounded in the regulatory frameworks that shape safety surveillance across development. The throughline is consistent: analytics take on a larger role as evidence accumulates, but expert medical judgment remains central to regulator-acceptable signal management at every stage.

See how to match your signal detection methods to each phase of clinical development. Download the white paper to read the full framework.