Formulations in early clinical development require a delicate balance of flexibility, simplicity, and scientific rigor. In first‑in‑human trials, dose ranges can vary by 10–100 fold increase between the starting dose a...
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Talking the talk
At ICON ensuring scientifically representative participation is not a stand-alone initiative, it’s embedded into every trial we support, shaping smarter, faster, higher-quality research. We start with the patient’s voice.
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Plan, lead, deliver: A framework for regulatory writing success
This article in IBI highlights how strategic planning, leadership and coordination are critical to delivering high quality regulatory submissions with confidence and efficiency.
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Making early AD trials feasible
Early intervention in neurodegenerative diseases, such as Alzheimer’s, offers the potential to slow or prevent disease progression, and increase success rates for clinical development.
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ICON named to TIME World's Most Sustainable Companies 2025 list
This list ranks the world’s 500 most sustainable companies based on their public commitment to and progress toward sustainability targets. ICON was one of nine Irish-based companies to make this global list, recognising the impact of our ICON Cares programme.
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The Evolving Cost-Benefit Landscape of Biosimilar Drug Development
The patent cliff for biologic medicines presents an opportunity for developers of biosimilars, but historically there are challenges too. The landscape however is changing, supporting easier paths to market.
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Regulatory Strategy, The Maestro
As part of Pharma Tech Outlook's Regulatory Strategy, The Maestro Q&A series, ICON answers a range of questions around regulatory in clinical trials, timing and other considerations.
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NHS App to match patients with clinical trials under 10-year health plan
Dr Andrew Garrett, Executive VP Scientific Operations, ICON, comments on the UK government’s announcement on boost to clinical trials.
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Exploring updates in adaptive trial safety monitoring
In this JCS article, ICON's experts discuss the key changes in FDA draft guidance on Data Monitoring Committees as it relates to adaptive design trials, providing practical insights and strategies for advanced safety oversight in the modern clinical trial landscape.
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Preparing to Achieve with Joint Clinical Assessments
Since Regulation (EU) 2021/2282 (HTAR) came into effect, HTDs need to plan for a Joint Clinical Assessment (JCA) in addition to submitting their CTD to the EMA or medical device technical file to their notified body. In this article, ICON discusses this new requirement, factors to consider and the benefits.
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AI is already delivering pharma value — and not just in drug discovery
This article highlights how AI is already adding value across pharma beyond headline‑grabbing drug discovery, with ICON leveraging its in‑house and proprietary AI tools—like its One Search site‑selection system, resource forecasting, endpoint strategy analytics, and document management platforms—to improve clinical trial efficiency and address enrollment challenges.
