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: Event report - DIA Europe 2021: Advancing health priorities
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
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Media article: Ensuring patient safety and cardiovascular clinical trial integrity during a global pandemic
ICON experts share insights on ensuring patient safety and cardiovascular clinical trial integrity during the COVID-19 pandemic.
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Media article: How COVID-19 has changed pharmacovigilance
The article explores how drug safety can be ensured while numerous vaccines and treatments come to market in record time to deal with COVID-19.
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Media article: An outsourced model for pharmacovigilance at an affiliate level
A thought leadership article on pharmacovigilance, written by Barry Rice and Sharlene Ahmed centered around improving oversight and reducing the risk of non-compliance.
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Media article: Use of televisits in studies and related PV concerns
As a result of the COVID-19 pandemic, televisits are becoming strongly considered as an alternative to on-site face-to-face visits, and as a new approach in virtual decentralised trials. ICON’s Xavier Fournie, a member of the EUCROF Pharmacovigilance Working Group, discusses the potential impact of televisits on pharmacovigilance (PV) processes.
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Media article: The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.
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Media article: Navigating an Ever Evolving Regulatory and Pharmacovigilance Landscape
In the 2020 edition of SCRIP Asia 100 ICON's Chuhua Wu outlines the variations in the structures, processes and outcomes of the pharmacovigilance status among Asian countries, with many diversities and complexities, and how a trend toward a more stringent regulatory environment in Asia is predicted.
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Blog: Clinical Safety Data Management - ICH E2B (R3)
In an increasingly globalised Pharmaceutical industry, harmonization is essential to assure the safety of patients.
