Postmarketing Methodologies That Improve Patient Safety
Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products. Safety issues may affect the risk-benefit balance of the product, requiring updates to product labels and other steps that help protect patients from harm.
At ProPharma Group, we have industry and regulatory experience with various signal management methodologies. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.
Wide-Ranging Signal Management Services
Signal management can be deployed throughout both the clinical development and postmarketing phases of the product lifecycle.
ProPharma Group has deep expertise across all signal management activities, including detection, validation, prioritization, and assessment. We do this using a wide range of sources, e.g., spontaneous cases, safety data from clinical trials, and non-interventional studies and literature reports. We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can ensure that Marketing Authorization Holders (MAHs) comply with their obligations for signal detection and management.