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Know up-front how AI use will impact your research acceptance. PubsHub Journals & Congresses incorporates AI policy guidelines in publication criteria to help select the right resource for publishing your research. Howev...

What can the industry learn about dose finding as immunotherapies such as cell therapies move into autoimmune disease? At this year's ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop, ICON's Patrici...

AI-enabled medical devices are evolving rapidly, moving beyond the detection of abnormalities to support diagnosis, treatment planning and more personalised patient care. As innovation accelerates, regulators worldwide a...

We are proud to launch the ICON Cares 2025 Report, highlighting progress across clinical research, our people, communities and responsible business practices. From supporting more than 1,370 clinical studies involving o...

Biosimilar development is evolving. As regulators place greater emphasis on analytical comparability and robust bioanalytical evidence, sponsors are being challenged to demonstrate biosimilarity with greater precision a...

ctDNA is a dynamic and variable marker influenced by testing method, tumor biology, and patient-specific factors. Consensus on testing methods and population-specific endpoint definitions will likely be needed before any...

Are you a manufacturer, a producer or both? In the second instalment of MedTech Insight's PPWR series, ICON contributors Claudia Anzaldo and Véronique Boscher (Perrin) highlight why medical device companies must first u...

The publication of ICH GCP E6(R3) Annex 2 marks an important step forward for clinical research. In Clinical Trials Arena, ICON's Wendy DeSpain, Global Head of Regulatory Strategy, explains that the most significant imp...

AI-enabled medical devices are entering a new phase. What began as tools for detection and triage is evolving into technology that can help inform diagnosis, treatment decisions and personalised care. As these capabili...

As regulators and HTA bodies place greater emphasis on real-world evidence, the European Health Data Space is creating new opportunities for cross-border research. Discover what EHDS means for study design, data access,...

How can sponsors demonstrate the value of a new cell or gene therapy when highly effective therapies are already established as standard of care? In a new paper published in the Journal of Biopharmaceutical Statistics, ...

The third article in MedTech Insight's PPWR series examines a growing challenge for medical device manufacturers: how to accommodate new packaging labelling requirements on already crowded device packaging. ICON’s Claud...