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Patient Safety and Pharmacovigilance

Insights and guidance to address patient safety through all stages of clinical ­research

As global regulatory frameworks evolve our pharmacovigilance and drug safety teams can guide clients to understand and address the latest updates to identify, evaluate, and manage risk throughout the drug and device development process.

The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities

Evolution of the Pharmacovigilance System Master File

This whitepaper provides an overview of the Pharmacovigilance System Master File (PSMF) and how it has evolved over the last ten years, both inside and outside of the European Union.

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Adopting an outsourced pharmacovigilance affiliate solution

Adopting an outsourced pharmacovigilance affiliate solution

This whitepaper explores the benefits in adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.

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Safety Reporting Solution

Taking safety reporting to the next level with automation

Our solution ensures compliance through automation. Based on an innovative cloud-based system and featuring automated and configurable business rules, it enables you to gain visibility into the safety profile of an investigational product throughout its lifecycle.

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Patient safety and pharmacovigilance blogs and media contributions