The European Health Data Space (EHDS) is set to transform how real-world evidence is generated across Europe. In this article, ICON authors explore how CROs must adapt to a new landscape of secure data access, interoper...
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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.
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Thailand’s competitive strength lies in its ability to consistently deliver high-quality clinical trials at scale
As Thailand seeks to strengthen its position in the ASEAN life sciences landscape, clinical research remains one of its greatest strengths. This article discusses the country's evolving ecosystem, competitive advantages, and the opportunities that could shape its next phase of growth and innovation.
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EU PPWR’s Two-Role Split Creates Costly Compliance Trap For Device Makers
The EU PPWR separates packaging compliance into two distinct roles — manufacturer and producer — with very different obligations. Conflating them is the most common error seen.
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Operational discipline is a critical determinant of clinical utility for neurologic monoclonal antibodies
In neurologic mAb development, the therapies that reach patients will be those designed not only to work, but to be delivered. Discover how operational discipline is emerging as a key differentiator in translating scientific advances into clinical utility.
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ICON partners with Anthropic in multi-year collaboration to deploy Claude's frontier AI across the clinical trial lifecycle
ICON's multi-year collaboration with Anthropic will bring Claude's AI capabilities to key clinical development workflows, helping accelerate innovation and enhance the delivery of clinical trials worldwide.
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ICON to deploy Claude AI across clinical trial lifecycle
ICON is deploying Claude AI across its organisation and clinical development operations, combining advanced AI capabilities with deep clinical expertise to improve efficiency, productivity and decision-making.
