Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities.

Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations.