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.

COVID-19 vaccines: Post-authorisation safety surveillance

This whitepaper explores the multifaceted challenges of COVID-19 post-authorisation safety surveillance studies and how business intelligence tools can benefit these efforts. 

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A guide to safety data migrations

Choosing the best approach to maintain data integrity

This whitepaper outlines the key advantages and disadvantages of manual data migrations, technical data migrations, and E2B data migrations.

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Pharmacovigilance Affiliate Model: Why outsourcing makes sense at an affiliate level

In this whitepaper, we consider the benefits of 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. We also explore the current challenges associated with managing local affiliate pharmacovigilance activities and potential ways to overcome these.

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Understanding the Periodic Benefit-Risk Evaluation Report

How careful preparation of the initial PBRER sets up future success

The International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). Gain insight about best practices that can be implemented during the process of creating an initial PBRER.

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Sponsor and CRO pharmacovigilance and safety alliances

This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.

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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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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