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.
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.
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.
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.
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.
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.
Patient safety and pharmacovigilance blogs and media contributions
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Blog: Post-marketing pharmacovigilance: Ensuring product safety in the real world
Explore the critical role of post-marketing pharmacovigilance in protecting patients and maintaining compliance after your product enters the market.
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Blog: Advancing pharmacovigilance in a changing landscape: 2024 World Drug Safety Congress
The 2024 World Drug Safety Congress brought together pharmacovigilance experts to discuss the challenges and solutions in their profession.
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Blog: How AI could transform literature surveillance for pharmacovigilance
In pharmacovigilance AI could be used to detect adverse events sooner, offering benefits for patients and researchers.
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Blog: ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
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Media article: Considerations for safety data migration methods
This article explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
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Blog: From clinician visits to data analysis: the challenges and solutions in COVID vaccine pharmacovigilance
Learn more about the challenges and solutions in assessing the long-term effects of Covid and Covid vaccines in this blog.
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Media article: Ensuring success in pharmacovigilance and patient safety
This article explores opportunities for outsourcing pharmacovigilance services, potential models, and best practices for selecting a service provider.
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Blog: Pharmacovigilance outsourcing: Tips for selecting a service provider
Selecting a vendor requires careful exploration and planning to ensure a successful relationship between sponsor and outsourcing partner.
