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More than a statistic: What EU Joint Clinical Assessment changes for oncology patients
This article by Dr. Liz O’Brien of ICON, outlines how the EU Joint Clinical Assessment is reshaping global oncology drug development by driving earlier evidence generation, strengthening patient‑centered trial design and enabling more equitable access to innovative treatments across Europe. It underscores the growing emphasis on patient insights, PROs and cross‑functional evidence planning one year after JCA implementation.
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The “R” in CRO: How and why CROs should harness open-source R software
In this Journal of mHealth article, Ashish Koul explains how open-source R software empowers CROs to modernise statistical workflows, cut costs and deliver more transparent, scalable analyses.
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From biopsy bottlenecks to biomarker breakthroughs - how non-invasive tools are reshaping MASH trials
This article examines how non-invasive testing could transform the management of metabolic liver disease and help shape the future of MASH clinical development. It also outlines the rapidly evolving NIT landscape, emerging regulatory perspectives, and key opportunities to optimise MASH trial design and execution.
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How digital health technologies are reshaping clinical development
Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher‑quality real‑world data.
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Submitting clinical data to the FDA and PDMA: An efficient and compliant approach
In this article, our data standards experts explain how sponsors can efficiently prepare clinical data submissions that meet both FDA and PMDA requirements by leveraging the substantial alignment between the two agencies’ standards.
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The formula for biotech success in 2026: Confidence, resilience and funding
For biotech companies the past two years have been challenging. In 2025 ICON Biotech conducted a follow-up survey of biotech leaders, previously carried out in 2023. The new results show changing trends in the risks, challenges and opportunities in the biotech sector.
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The solution to persistent startup bottlenecks? Refocusing on site centricity
Study startup, and specifically, feasibility, site selection and activation, remains one of the most critical yet challenging early phases of clinical trial delivery. The solution to persistent startup bottlenecks? Refocusing on site centricity.
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Interview series: Part 1 of 5 - Rethinking site activation to cut startup timelines
How contract standardisation, proactive budget alignment, and AI-enabled negotiation tools can reduce site activation delays and turn agreements into strategic accelerators.
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Interview series: Part 2 of 5 - Closing communication gaps during study startup
Why persistent communication breakdowns between sponsors, CROs, and sites undermine startup efficiency—and how bidirectional, site-informed engagement models can improve collaboration and momentum.
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Interview series: Part 3 of 5 - Applying AI to reduce administrative burden without losing the human touch
How practical AI applications can streamline contracts and startup workflows while preserving the central role of investigators, site staff, and patient relationships.
