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...
In the News
ICON experts frequently author or contribute to industry trade press.
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Multidrug-Resistant Infections Necessitate Bacteriophage Treatment: Can We Get There in Time?
As antibiotic resistance surges globally, bacteriophage therapy is emerging as a promising alternative for treating multidrug-resistant infections. To scale this life-saving approach, investment in phage development, clinical trials, and diagnostic infrastructure is urgently needed.
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CRO reforms: Tilting scale towards accelerated growth and transparency
The article, featuring commentary from Nagalakshmi Shetty, highlights how India's clinical research sector is rapidly expanding. Regulatory reforms like the Central Drugs Standard Control Organisation's NDCR (Amendment) Rules 2024, mandatory CRO registration and digitised portals are boosting transparency, shortening approval timelines and positioning India as a global hub for clinical trials.
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Keeping it real
In this PharmaTimes article, Nagalakshmi Shetty explores how clinical data science is evolving from traditional management toward intelligent, risk-based, patient-centric research frameworks.
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Navigating, manufacturing, infrastructure and regulatory hurdles in CAR T-Cell therapy growth
Explore how industry leaders are overcoming manufacturing and regulatory hurdles to scale CAR-T cell therapies across Asia-Pacific.
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ICON recognised as one of World's top companies for women
ICON have been included in Forbes' list of only 400 global companies. Based on a survey of approximately 120,000 women in more than 36 countries, positions were awarded to companies that have been identified as top performers in promoting gender equality and supporting women in the workplace.
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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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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.
