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The “R” in CRO: How and why CROs should harness open-source R software
In this Journal of mHealth article, Ashish Koul explains how open-source R software empowers CROs to modernise statistical workflows, cut costs and deliver more transparent, scalable analyses.
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The solution to persistent startup bottlenecks? Refocusing on site centricity
Study startup, and specifically, feasibility, site selection and activation, remains one of the most critical yet challenging early phases of clinical trial delivery. The solution to persistent startup bottlenecks? Refocusing on site centricity.
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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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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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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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Plan, lead, deliver: A framework for regulatory writing success
This article in IBI highlights how strategic planning, leadership and coordination are critical to delivering high quality regulatory submissions with confidence and efficiency.
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Exploring updates in adaptive trial safety monitoring
In this JCS article, ICON's experts discuss the key changes in FDA draft guidance on Data Monitoring Committees as it relates to adaptive design trials, providing practical insights and strategies for advanced safety oversight in the modern clinical trial landscape.
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How Global Capability Centers are Shaping the Future of Biometrics
In this interview with India Pharma Outlook, Nagalakshmi Shetty discusses India's emergence as a hub for Global Capability Centres (GCCs), emphasising GCCs' evolution from cost-saving units to innovation-driven strategic centres for global businesses.
