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In the News
ICON experts frequently author or contribute to industry trade press.
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Developing Robust Submission Strategies for Combined Studies
Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic device. For sponsors this means their studies have additional regulatory requirements to meet, each on very distinct submission pathways. Read the full article.
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Understanding EU regulatory requirements for studies with medical devices and in vitro diagnostic devices
Treatments are being developed that use medical devices, combination products and in vitro diagnostic medical devices. However, before patients benefit from these new treatments, use of these devices within clinical trials is subjected to scrutiny by different regulatory agencies.
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Innovation and flexibility in long-term follow-up studies
Read insights from Harpreet Gill VP, Real World Solutions, on how sponsors can optimise their LTFU studies to be flexible and cost-effective, with strategic planning and innovation, overcoming challenges while capturing valuable data insights.
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Cover Story - Regulatory CMC: Enhancing Biologics Development
Preventing delays and accelerating the progression of these critical therapies.
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The future of RWD and RWE in healthcare decision-making: Applications of novel real-world data collection methods for healthcare decision-making
Read insights from Jennifer Eriksson, Divisional Principal, on the use of real-world evidence and real-world data to inform healthcare decision-making and provide patients with rapid access to innovative healthcare technology.
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ICON interview: Insights on the new EMA guidelines for computerised systems and electronic data in clinical trials
Outsourcing Pharma spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, who shares her insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new expectations it sets for the clinical research industry.
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Implications of regulatory and FDA guidance on diversity, equity and inclusion on clinical research study sites
Following discussions at the 2023 Global Site Solutions Summit, Missy Gottschlich, Director of Site Networks for Accellacare, provides key insights on how sites can implement regulatory guidelines on diversity, equity and inclusivity in this article in pharmaphorum.
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Confidently compliant? Considerations for industry players to meet the new EMA guideline
Vesta Marciulioniene, Director, Global Regulatory Clinical Services and Jo Hulbert, Executive Director, Global Regulatory Clinical Services provide an overview of the EMA’s new framework on computerised systems and electronic data in clinical trials in this article from XTalks Clinical Edge.
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Essential considerations for a successful submission under EU CTR
A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions. CTIS enables harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.
Published by International Biopharmaceutical Industry Journal Volume 6 Issue 2
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Comparing treatment performance through evidence synthesis
If there is a variety of treatment options in a specific disease area, decision makers require evidence of efficacy and safety of novel interventions in comparison to established treatments. One randomised controlled trial (RCT) is not sufficient to come to a final conclusion, especially since RCTs often present contradictory results.
Published by Journal for Clinical Studies Volume 15 Issue 2 (https://journalforclinicalstudies.com/).
