SIGNAL MANAGEMENT

The Council for International Organizations of Medical Sciences (CIOMS), defines a safety signal as "information that arises from one or multiple sources (including observations or experiments), which suggests a new, potentially causal association, or a new aspect of a known association between an intervention [e.g., administration of a medicine] and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action." Identification of signal involves the evaluation of the cosmic volume of data be it Regulatory information, Clinical study data, or Scientific literature. Though statistical analysis of data contributes to the generation of safety signals but the importance of hands-on medical review of data cannot be undermined. It is vital to understand that a critical analysis of adverse events in this scenario is mandatory as labeling of an adverse event as signal will alter the drug's risk benefit ratio. This has far-fetched consequences for the safety of the patient and society in large. The team at AWINSA Life Sciences has rock-solid foundation of academics topped with sharp clinical judgment and expertise. They are adept at doing a critical analysis of the adverse event scenarios.