Driving compliance in fully remote Alzheimer’s trials is complex, ICON Concierge Services makes it possible. In a pre-clinical study with 600+ participants and over 50 ePROs per patient, Concierge direct-to-patient serv...
In the News
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Clinical trials - Keeping pace with shifting drug development paradigms for multi-indication therapies
In this article, learn how sponsors can drive multi-indication success through strategic trial design, early cross-functional planning, and evidence-driven development.
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Fights over Tylenol, SSRIs highlight the enduring lack of pregnant women in drug trials
Read the article to learn why the exclusion of pregnant women from clinical trials continues to fuel data gaps, misinformation, and missed opportunities for safer, more effective treatments.
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Smarter strategies for systematic literature reviews
Conducting a high-quality, clinically relevant literature review can be challenging – it demands strategic thinking, methodological rigour and therapeutic expertise. ICON expert Rebecca Rozich explains why systematic literature reviews can be a powerful alternative to generating new data.
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Beyond approval
In the October issue of PharmaTimes, Dr. Quintin van Wyk considers the importance of post-marketing pharmacovigilance, and explains how carefully applied automation and AI can strengthen adverse event reporting and causality assessment while keeping patient safety and regulatory compliance central.
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Impact assessment is the first, critical step to updated ICH GCP compliance
ICH GCP E6(R3) is here. In the latest issue of PharmaTimes, ICON explores why a comprehensive impact assessment is the essential first step toward strategic compliance.
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How cancer regulation is — and isn’t — changing at FDA: a BioCentury podcast
Dr. Liz O’Brien, Senior Director of Global Drug Development at ICON and former EMA regulator, joined the BioCentury This Week podcast to share insights on navigating FDA’s Project Optimus, the EMA’s Joint Clinical Assessment and highlight the key differences between the two regulatory regimes.
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Unlocking the potential of GLP-1 based therapies with RWE
A recent ICON survey found fewer than 15% of sponsors use RWE to inform their multi-indication development strategy for obesity-related drugs. Learn best practices for leveraging RWE for GLP-1 based therapies in our article.
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ICON’s new CEO champions AI and efficiency during industry’s ‘pivotal time’
ICON's new CEO, Barry Balfe, speaks to BioXconomy on industry challenges - and opportunities - ahead.
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Cardiovascular outcomes trials revisited – methodological enhancements for greater clinical relevance.
ICON experts, Pierre Martineau and Adrienne Stoudenmire, share key considerations for successful CVOTs including study design, data strategy and technology in this new article.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
