In the last few years signal management has caught the attention of regulatory authorities, especially in the context of the exponential rise in data volume and the change in the type of sources. At Med Communications, the Pharmacovigilance (PV) team is constantly refining their skills and technologies to provide our clients with state-of-the-art methodologies for signal detection and management activities.
Med Communications’ signal management processes are focused on the review of aggregate data from all sources, the analysis of individual case safety reports (ICSRs), and the impact of emerging signals on the risk-benefit profile of the product. Our team applies a comprehensive approach to optimize signal detection and management activities, finding efficiencies and leveraging the appropriate methods without compromising quality. Our best practice-based process takes into account the characteristics of our clients’ portfolios and includes the most effective methods to their data sets.
Our PV team provides oversight, reviews signals, and offers valuable recommendations. We perform routine analysis and identification of potential signals, signal validation, confirmation, signal analysis, and prioritization, as well as signal assessment and recommendations for action, in accordance with applicable regulations (Good Pharmacovigilance Practices [GVP]—Module IX, FDA’s Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, CIOMS Working Group VIII recommendations, etc).
Through our expertise and clearly defined process, applying consistent signal evaluation and documentation methods, validated templates, and a well-established decision process, we provide an audit-ready environment.