Formulations in early clinical development require a delicate balance of flexibility, simplicity, and scientific rigor. In first‑in‑human trials, dose ranges can vary by 10–100 fold increase between the starting dose a...
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How digital health technologies are reshaping clinical development
Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher‑quality real‑world data.
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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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Interview series: Part 1 of 5 - Rethinking site activation to cut startup timelines
How contract standardisation, proactive budget alignment, and AI-enabled negotiation tools can reduce site activation delays and turn agreements into strategic accelerators.
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Interview series: Part 2 of 5 - Closing communication gaps during study startup
Why persistent communication breakdowns between sponsors, CROs, and sites undermine startup efficiency—and how bidirectional, site-informed engagement models can improve collaboration and momentum.
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Interview series: Part 3 of 5 - Applying AI to reduce administrative burden without losing the human touch
How practical AI applications can streamline contracts and startup workflows while preserving the central role of investigators, site staff, and patient relationships.
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Interview series: part 4 of 5 - Why startup timelines are worsening – and how to reduce the trend
The operational pressures driving longer activation timelines, from protocol complexity to site competition, and how earlier, more flexible site engagement can restore momentum.
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Interview series: Part 5 of 5 - Centering site experience to accelerate site activation
How sponsor and CRO practices that prioritise site needs, clarity, and partnership can strengthen trust, sustain momentum, and speed activation.
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Examining the growing delays in clinical trial start-up
Brian Mallon discusses the increasing timeframe from site selection to full activation, including the issues contributing to the delay and measures to address them.
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New ICON survey shows sites face growing delays and communication gaps during study startup
ICON’s survey of more than 100 investigators and site leaders reveals persistent bottlenecks in study startup driven by contract and budget delays, slow activation timelines, and insufficient collaboration from sponsors and CROs.
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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.
