Signal Management Services

Categories

Description

Services for signal detection, validation, prioritization, and assessment in pharmacovigilance.

Summary

ProPharma Group's Signal Management Services encompass all critical aspects of signal detection and management in pharmacovigilance, including validation, prioritization, and assessment. Leveraging a wide range of data sources and expertise in EudraVigilance Data Analysis System (EVDAS), these services support Marketing Authorization Holders (MAHs) in fulfilling their signal detection and management obligations. The approach is designed to be simple yet scalable, ensuring client needs are met throughout the product lifecycle while prioritizing patient safety and regulatory compliance.

Use Cases

• A pharmaceutical company uses the service for early detection of potential safety risks from a new medication.
• A biotech firm leverages the service for ongoing monitoring and management of adverse event reports during post-marketing surveillance.