Signal Detection and Management Services

A signal is any safety information derived from various sources, indicating a new potentially causal relationship or revealing a new aspect of a known association between an intervention and an adverse or beneficial event. Our rigorous signal management process considers the intricacies of each signal, including changes in frequency, distribution, duration, severity, and outcome of adverse reactions.

We tailor our signal management activities to meet specific client requirements, ensuring the delivery of reliable, high-quality, and traceable data in full compliance with local regulatory guidelines. Our team of experts excels in signal management services and provides comprehensive responses to safety inquiries from Health Authorities. We offer strategic advice on approaching HA queries, critically appraise Individual Case Safety Reports (ICSRs), aggregate data and literature, and deliver thorough evaluation reports that assess the strengths and weaknesses of all reviewed data sets and sources.

• Signal Detection: Prompt identification of potential safety signals.
• Signal Validation and Confirmation: Thorough validation and confirmation processes for identified signals.
• Signal Analysis and Prioritization: In-depth analysis and prioritization of signals based on their significance and potential impact.
• Signal Assessment: Comprehensive assessment of signals, considering their potential implications and risks.
• Authoring of Signal Management Reports: Meticulous creation of reports detailing all identified signals and their management strategies.
• Support for Labeling Updates: Assisting with necessary updates to product labelling based on identified signals and their implications.