Modern RBQM models redistribute monitoring activities across central, remote and onsite teams, helping sponsors focus oversight where it matters most. In her article for BioPharm International, Helen Yeardley examines w...
ICON experts frequently author or contribute to industry trade press.
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How Evolving Biosimilar Guidance Is Reshaping Bioanalytical Strategy
This article discusses how regulatory change makes bioanalytical testing, such as CMC analysis, as well as PK/PD studies, more important for getting regulatory approval.
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ICON taps Anthropic and Microsoft as it puts clinical-trial agents into production
In this R&D World article, Tony Clarke, Senior Vice President, Enterprise AI, discusses how ICON is leveraging AI agents to improve efficiency and accelerate clinical trial delivery.
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ICON taps Anthropic’s Claude to bring agentic AI to clinical trials
ICON is pairing frontier AI capabilities with its deep clinical trial management across its global footprint, targeting structural inefficiencies in global trial execution.
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The PPWR mandate: Essential strategies for pharma and medtech
In this article, ICON's regulatory experts explore the practical implications of PPWR and the strategies organisations should be considering now.
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Connected trials
A central theme of a recent discussion between leaders from ICON, Advarra and the site community was how sponsors, CROs and technology partners can better align study delivery with the operational realities of research sites.
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AI methods for regulator-ready real-world evidence in NSCLC
This article explores how AI can transform real-world data in non-small cell lung cancer into reliable, regulator-ready evidence, helping researchers generate insights that complement clinical trials.
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Navigating the adoption of biomarker-informed trial enrollment beyond oncology
Learn how biomarker-informed enrollment strategies can help sponsors improve trial efficiency, identify likely responders and accelerate development beyond oncology, while avoiding common pitfalls that can impact approval and access.
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Advances in risk assessment shift the calculus of early intervention trials for MASLD
Discover how evolving risk assessment strategies are helping sponsors optimise early intervention trials in MASLD. Read the full article.
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EU PPWR: Minimising medtech packaging without losing protection
The fourth and final article in MedTech Insight’s PPWR series examines how medical device manufacturers can minimise packaging without compromising product protection, sterility or regulatory compliance.
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Regulatory trends in AI-enabled SaMDs
With AI-enabled SaMD authorisations accelerating worldwide, regulatory requirements are evolving just as quickly. This article highlights the latest trends, global regulatory developments, and practical considerations for bringing the next generation of AI-driven medical technologies to market.
