Participant-centric study design has advanced, but site-centric execution has not kept pace. In the Journal for Clinical Studies, Brian Mallon examines how unclear expectations, administrative burden and contract delays ...
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Next-generation modalities, precision trials, and AI-driven breakthroughs in oncology
The panelists discussed promising scientific and strategic pathways in oncology, including next-generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.
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The CRA role’s co-evolution with clinical trial technology
As clinical trials become more complex, the role of the CRA is evolving from site monitor to strategic, digitally fluent partner, requiring expertise in hybrid oversight, risk-based monitoring, and multi-system data management.
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Bold moves
CRAs are at the centre of clinical trial evolution. Risk-based monitoring, intelligent oversight tools and AI are changing how trials are managed. ICON explores what this means for the future in Pharma Times.
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Transforming central labs with automation and AI: setting new standards for modern trials
Demands on central laboratories are consistently increasing, heightening the challenge to deliver operational excellence and the highest standard of scientific integrity with both speed and agility. ICON Laboratories is transforming the way we leverage data and intelligent operational models to meet evolving trial needs.
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Regulatory strategy reimagined: Three trends accelerating drug development
The regulatory landscape is being rewritten. The future belongs to those who anticipate, adapt and act with purpose. In this article we look at 3 macro trends that are redefining regulatory strategy.
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Precision medicine meets machine learning: AI and oncology biomarkers
AI is redefining oncology biomarker discovery, unlocking new precision in patient selection and trial design. Explore how this evolving technology is shaping the future of cancer drug development.
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Smarter starts, stronger trials: How data is driving faster site activation
Feasibility, site selection and study startup are among the most complex areas of clinical development, yet they remain stubbornly inefficient. ICON’s Brian Mallon explores how sponsors and CROs are leveraging AI, predictive analytics and integrated data environments for faster, more predictable trial delivery and stronger site partnerships. Read the full article.
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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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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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Navigating global regulatory expectations for AI-enabled devices
Despite the increasing use of AI in medical devices and software as medical devices (SaMD), global regulatory authorities are playing catch up to develop appropriate submission channels.
Read the article in Med-Tech Insights.