The conversation around AI in healthcare is changing. The question is no longer whether AI can support clinical decision-making. The question is how regulators, developers and healthcare systems can ensure these technol...
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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.
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ICH GCP Annex 2 will strengthen sponsor confidence in the use of DCTs and RWD
Sponsors have increasingly adopted new clinical trial models, including decentralised trials and real-world data, but has global regulatory harmonisation been lacking?
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How AI-enabled software as medical devices are reshaping regulatory routes and medicine
As AI-enabled software as medical devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.
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EU PPWR labeling for medtech: New symbols, old space problem
Device packaging is already among the most heavily regulated real estate on the EU market thanks to MDR and IVDR requirements. And now the PPWR stacks on a second layer.
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Shifting GLP-1 research and development: lessons learned from the first-generation
First-generation GLP-1 programmes reshaped metabolic drug development. Explore the clinical, commercial and operational lessons helping sponsors navigate the next wave of obesity and cardiometabolic innovation.
