For the second article in our new series, we delve deeper into ISO 14971 (Application of risk management to medical devices). We discuss a history of risk-based thinking and common misunderstandings around risk analysis ...
In the News
ICON experts frequently author or contribute to industry trade press.
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Beyond approval
In the October issue of PharmaTimes, Dr. Quintin van Wyk considers the importance of post-marketing pharmacovigilance, and explains how carefully applied automation and AI can strengthen adverse event reporting and causality assessment while keeping patient safety and regulatory compliance central.
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Impact assessment is the first, critical step to updated ICH GCP compliance
ICH GCP E6(R3) is here. In the latest issue of PharmaTimes, ICON explores why a comprehensive impact assessment is the essential first step toward strategic compliance.
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How cancer regulation is — and isn’t — changing at FDA: a BioCentury podcast
Dr. Liz O’Brien, Senior Director of Global Drug Development at ICON and former EMA regulator, joined the BioCentury This Week podcast to share insights on navigating FDA’s Project Optimus, the EMA’s Joint Clinical Assessment and highlight the key differences between the two regulatory regimes.
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Unlocking the potential of GLP-1 based therapies with RWE
A recent ICON survey found fewer than 15% of sponsors use RWE to inform their multi-indication development strategy for obesity-related drugs. Learn best practices for leveraging RWE for GLP-1 based therapies in our article.
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ICON’s new CEO champions AI and efficiency during industry’s ‘pivotal time’
ICON's new CEO, Barry Balfe, speaks to BioXconomy on industry challenges - and opportunities - ahead.
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Cardiovascular outcomes trials revisited – methodological enhancements for greater clinical relevance.
ICON experts, Pierre Martineau and Adrienne Stoudenmire, share key considerations for successful CVOTs including study design, data strategy and technology in this new article.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
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ICON makes TIME World's Best Companies list for 3rd year in a row
ICON are once again honoured to be featured on the TIME World's Best Companies list in 2025. Entrants on the list are ranked based on their performance on three key metrics - employee satisfaction, revenue growth and sustainability transparency.
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Promised land
As global pressures reshape the pharmaceutical and biotech landscape, sponsors are re-evaluating their outsourcing strategies. ICON’s recent survey of industry stakeholders highlights a clear trend toward fit-for-purpose solutions.
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Collaborative R&D: Partnerships shaping the future of biopharma
Biotechs and pharma companies face rising costs of drug development, depleting R&D pipelines and diminishing returns on investment. By joining forces and exploring collaborative R&D partnerships it is possible to overcome these challenges. In addition to sharing risks, they share the potential rewards when their assets move further into clinical development or come to the market.
