White Paper:

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports-1

Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug–AE pairs to analyze, the issue of focus is daunting.

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Evidex Signal Management

A next generation pharmacovigilance workflow platform that allows an organization to track and resolve safety signals and inquiries.

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Best-in-Class UX/UI

Built within the Evidex framework, Evidex Signal Management provides audit ready tools that safety reviewers want to use

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Automation Made Easy

Fully integrated and automated signal detection from multiple data sources, powered by Evidex Data & Analytics provides a wholistic, modern approach to pharmacovigilance

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Validated Off-the-Shelf

Validated off-the-shelf configuration based on GVP Module IX offers fast, compliant, and lean implementation, while maintaining the flexibility to meet any organization's unique needs

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