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Demographic Matching in Organ Impairment Studies: Why It Matters Organ impairment (OI) studies are critical for safe and effective drug development—but did you know that demographic matching can make or break the accurac...

In 2025 ICON was recognised in global rankings by both TIME and Fortune magazines celebrating organisations excelling in financial stability and environmental sustainability. Learn more. https://ow.ly/aqkw50XSPP5

Continuing our series of articles discussing managing risk for medical devices, ICON’s regulatory expert Jeremy Tinkler turns his focus on the biological risk estimate and looks into the logical basis for the use of comp...

The key to estimating biological risk in medical devices is establishing a good comparison. However, identifying the right comparison can be challenging. In the latest blog in our managing risk for medical devices series...

Innovation is accelerating progress in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions bring together advanced formulation design, real-time dose flexibility, and world-class CMC expertise to si...

For medical device developers selecting the right AI model and data is crucial to capitalise on this powerful technology. Our new whitepaper explains best practices for AI-enabled devices. Learn about AI models, datase...

Do you know the difference between decision trees and random forests? Learn about AI models for SaMDs in our new whitepaper. Download it now to learn best practices for model and data selection. https://ow.ly/nI8g50XAzbq

Missed our recent webinar from Symphony Health, an ICON plc company? The recording for Riding the data wave: How pharma can navigate disruptions in open claims is now available. Discover how life sciences organisatio...

From long‑acting ART to vaccines and curative treatments, innovation is accelerating. Explore ICON’s new HIV whitepaper for insights on breakthrough therapies, including twice-yearly injectable PrEP, vaccines, and curati...

2025 has seen both the EMA and the FDA publish new position papers and opinions on streamlining the trial process for biosimilars. On the surface, reducing reliance on comparative efficacy trials has the potential to sav...

There is great excitement following the announcements by the FDA and EMA around streamlining the biosimilar trial process. They promise to reduce the burden on developers and therefore increase the number of more afford...

The EU is moving toward MoA-based pediatric planning, following the precedent set by the RACE Act in the US. This approach promises better outcomes for children and more innovative medicines, but it requires early, integ...