Signal Management
Postmarketing Best Practices That Improve Patient Safety
Signal management is a dynamic and essential process for the preemptive and timely identification of potential new safety risks for medicinal products. Safety concerns may affect the risk-benefit equilibrium of the medicinal product, necessitating real time updates to product labels and other risk mitigation steps that help protect patients from harm.
At Gemini Group, we have industry leading experience and regulatory knowledge with various signal management best practices. We leverage our vigorous knowledge to select the most effective and successful best practices for each asset that is compliant with legislative requirements.
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Comprehensive Signal Management Services
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Gemini Group has leading industry experience and knowhow in creating efficient, compliant, multidisciplinary processes for signal detection and management. We utilize the latest strategies, statistical methodologies and data mining approaches within product safety risk management systems.
Gemini Group is well versed in the understanding of outputs from automated data mining analyses. Gemini Group subject matter experts have been directly involved in hands-on discussions with the EMA EV-WG and in developing proper answers following the new sponsor responsibilities for signal management based on GVP Module IX updates.
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Signal management can be implemented throughout both the clinical development and postmarketing phases of the product lifecycle.
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Gemini Group has deep know-how across all signal management activities, including detection, validation, prioritization, and assessment. We do this using an extensive range of sources, e.g., spontaneous cases, safety data from clinical trials, and non-interventional studies and literature reports. We are also fully educated and well practiced in the EudraVigilance Data Analysis System (EVDAS) functionality and can ensure that Marketing Authorization Holders (MAHs) fulfill their obligations for signal detection and management.
