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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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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Best practices in linguistic validation of clinical outcomes assessments
At first glance, translating clinical outcome assessments (COAs) from their original language to other languages appears to be no more complicated than other trial planning elements. However, as scientific instruments, the process is much more complex. COA translation needs to consider conceptual equivalency and cultural relevance.
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Expanding diagnostic and biomarker options to improve MASH clinical trials
The absence of sufficient and accessible diagnostics for metabolic dysfunction-associated steatohepatitis (MASH) studies can complicate trials and impair clinical study conduct, as diagnostics are essential for disease detection, confirmation, and monitoring.
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Advances in imaging biomarkers: Estimating efficacy with tumour growth rate modelling
Imaging biomarkers are an essential part of oncology trials, tracking the efficacy of the new treatment and comparing it to the existing gold standard therapies. The insights gleaned from imaging biomarkers steer the course of oncology clinical trials, informing decision-making and endpoints. This article discusses the benefits of tumour growth rate modelling.
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Oncology R&D: emerging therapies and new challenges
Worldwide demand for cancer therapies is set to soar – and biomanufacturers are in the spotlight. Explore emerging industry data to distinguish trends and prepare for the future of oncology.
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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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Blended outsourcing models: Driving strategic flexibility and operational excellence
The clinical research industry is at a turning point. As trials grow more complex and development costs continue to rise, biopharma sponsors are reevaluating how they partner more efficiently with contract research organisations.
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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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Girls see gender inequality as biggest barrier to pursuing Stem careers
Rose Kidd, President, Operations Delivery, provides an overview on how ICON is working to meet its gender balance ambitions in the Irish Times Life Sciences and Stem supplement.
