Vaccine guidance for patients with rare autoimmune diseases can be challenging, given the low prevalence of some of these conditions and limited understanding of the impacts of vaccines in these patients. Discover how va...
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Submitting clinical data to the FDA and PDMA: An efficient and compliant approach
In this article, our data standards experts explain how sponsors can efficiently prepare clinical data submissions that meet both FDA and PMDA requirements by leveraging the substantial alignment between the two agencies’ standards.
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The formula for biotech success in 2026: Confidence, resilience and funding
For biotech companies the past two years have been challenging. In 2025 ICON Biotech conducted a follow-up survey of biotech leaders, previously carried out in 2023. The new results show changing trends in the risks, challenges and opportunities in the biotech sector.
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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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Pharma communications resilience: Navigating regulatory policy shifts with strategic precision
Regulatory change often brings unexpected challenges to an already complex environment. Product labelling is no exception. Yet, with the right foundation, organisations can transform uncertainty into opportunity. A well-balanced mix of skilled personnel, timely intelligence and agile processes equips organisations to stay ahead of regulatory shifts.
