Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...
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Real-World Evidence in transition: CRO adaptation to the European Health Data Space framework
This article explores how the European Health Data Space (EHDS) is transforming real-world evidence generation by shifting CROs from data custodians to regulated data users operating within secure, interoperable environments, creating new opportunities for pan-European research while requiring greater investment in compliance, data standardisation and methodological rigour.
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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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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 global regulatory expectations for AI-enabled devices
Despite the increasing use of AI in medical devices and software as medical devices (SaMD), global regulatory authorities are playing catch up to develop appropriate submission channels.
Read the article in Med-Tech Insights.
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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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ICON discusses how AI is changing clinical trial recruitment and diversity
Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.
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AI-powered precision measures: A golden opportunity for clinical research
As the cost of developing new therapies continues to rise, pharma executives must turn to technologies that drive better insights into de-risked investments and produce operational efficiencies. AI-powered digital measures are being developed and validated to better define disease, patients, and drug efficacy.
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AI’s transformative role in drug discovery and development
In the Irish Times Life Sciences and Stem supplement, ICON’s CIO Tom O’Leary discussed AI is transforming drug development across a range of specific use cases, from discovery to clinical trials and post-marketing.
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Half of pharma and biotech companies using AI and big data
This news piece from Clinical Trials Arena provides an overview of the findings of ICON’s recent Digital Disruption survey, which found sentiment towards artificial intelligence and digital tools in the clinical research sector is positive.
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Ensuring data integrity and quality in clinical research outcomes
In this interview with Asia Business Outlook Magazine, Nagalakshmi Shetty, Vice President & India Country Head shares how changes in data management have changed the way clinical research is practiced and emphasises the role of interdisciplinary collaborations in progressing research.
