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In this new blog series, we review ISO 14971 (Application of risk management to medical devices) - its history, the principles embedded within it and how it relates to other standards and regulation. For the first editio...

Meet ICON experts at the AASLD to learn how ICON partners with sponsors, investigators, patients and other collaborators to deliver strategic, data-driven solutions for MASH and hepatology studies. https://ow.ly/9QBn50X8...

Digital measures, including digital biomarkers and digital endpoints, offer sponsors powerful ways to assess treatment effect in real time, in the real world. But to be meaningful, those measures must be carefully selec...

Teams incorporating DHTs into their protocol design may grapple with the question of how to transform raw sensor data into a validated, regulatory-ready digital endpoint. Start with the V3 framework: 🔬 Verification 📊...

The PHUSE single day event in Bloemfontein will bring together leading professionals to explore innovations shaping clinical data science. ICON is proud to contribute to these discussions, focusing on topics such as digi...

Post-marketing pharmacovigilance plays a crucial role in maintaining patient safety once a product reaches the market. While automation can streamline certain tasks, its implementation must be carefully managed to avoid ...

Early clinical trial designs—especially first-in-human (FIH) studies—are increasingly tailored to the unique needs of specific therapeutic areas. In neurodegenerative diseases, there is a growing shift toward flexible an...

ICON is proud to be recognised among the top global companies in the world for female employees. As of 31 December 2024, women make up 70% of our workforce and hold 60% of director-level and above roles—a powerful refle...

By prioritising community engagement, enabling remote enrollment, and clearly communicating risks and benefits, researchers and sponsors can help create safer, more inclusive clinical trials for pregnant individuals. Exp...

Planning an Integrated Summary of Safety and Efficacy (ISS/ISE) submission can be demanding, especially when studies differ in format or terminology. This blog explains how early preparation and the right integration str...

Connect with ICON experts at #ObesityWeek, booth \#520 to learn about our proven success designing and executing early phase studies, supported by a robust database of overweight/obese volunteers and in-house clinical re...

Over the past five years, ICON has participated in over 840 oncology and haematologic malignancy, and 83 non-malignant haematology, clinical studies globally. Meet ICON experts at #ASH25, booth \#2161 to learn how our fl...