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ICON experts frequently author or contribute to industry trade press.
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Clinical strategies to optimize software as a medical device to treat mental health
Every clinical trial has challenges, but trials researching SaMD use to treat mental health disorders have unique ethical, regulatory and technical ones. In this Applied Clinical Trials article ICON’s Devin Ridgley and JoAnne Bronikowski explore the implications of a vulnerable patient population and new technology.
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Navigating protocol development in early phase trials
In an ICON survey of 149 biotech professionals, 45% of survey respondents identified protocol design as one the most significant challenges faced when transitioning from preclinical to clinical testing. Here, we discuss considerations for several key elements of protocol development in early phase trials, including selection of healthy volunteers (HVs) or patients, trial design and endpoint selection.
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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.
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The rising impact of biomarkers in early clinical development
Dr. Cyril Clarke at ICON Biotech reveals how biomarkers are transforming early-phase clinical trials by offering valuable insights into the safety and efficacy of novel therapies.
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Grappling with the Grey Zones in EMA Computerised Systems and Electronic Data implementation
The EMA’s Computerised Systems and Electronic Data in Clinical Trials guideline still presents challenges for those seeking EU marketing authorisation. Read our latest regulatory article in IPI magazine to learn more.
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Developing New Talent in Regulatory Medical Writing: AMWA Apprentice Program Framework
In this article, Rhona Grunspan describes the development of the first industry-standard framework for a regulatory medical writing apprentice program, created to support the training and recruitment of entry-level medical writers through adaptable resources and guidelines. (Subscription required)
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Harnessing AI and big data in clinical research
The article explores the evolving role of AI and digital technologies in clinical research, highlighting industry trends, adoption challenges, and the potential for improved efficiency, cost reduction, and accelerated drug development.
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AI, Big Data, and Digital Disruption
This article takes a look at ICON's recent digital disruption survey which surveys changing attitudes and challenges in digital innovation for clinical research.
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ICON integrates Medidata’s Clinical Data Studio into clinical studies
The integration improves decision-making processes and supports AI-driven risk evaluation strategies.
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Comment: Realising the full potential of biomarker-informed clinical trials for neurodegenerative disorders
This article by Peter Schueler is based on the recent whitepaper, “Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D”. It explores how the recent approval of amyloid-targeting monoclonal antibodies for Alzheimer’s, following decades of failed trials, can be partially attributed to the development of improved biomarkers for patient screening and outcomes assessment.