Participant-centric study design has advanced, but site-centric execution has not kept pace. In the Journal for Clinical Studies, Brian Mallon examines how unclear expectations, administrative burden and contract delays ...
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Devices regulation offers opportunities and challenges for medtech
In this piece from the Irish Times, Cynthia Nolte, Director, Regulatory Affairs, Strategic Regulatory Services outlines that while there are challenges with the EU Medical Devices Regulation, the requirements do provide manufacturers with an opportunity to audit portfolios and eliminate unprofitable products.
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AI has the power to revolutionise drug discovery and design
In this article from the Irish Times, Gerard Quinn, VP of IT Innovation and Informatics provides insight on how artificial intelligence can support the drug development process in order to deliver new treatments to more people, faster.
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Decoding pandemic precision: From SARS-CoV-2 to influenza vaccination strategies
The need for public health officials to be able to model the spread of infectious diseases has never been more apparent than in the early days of the SARS-CoV-2 pandemic, but what needs to change? Read the article by ICON epidemiologist Dr. Richard Pitman in Open Access Government.
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Shaking it up: The partnership paradigm in clinical research
Jeff James, Executive Vice President, Alliance Management, explores how outsourcing methodologies between large pharmaceutical companies and CROs have rapidly evolved across the healthcare and clinical research landscape.
Read the article on page 13 of the December issue of PharmaTimes.
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Evolution in the outsourcing of clinical research
Partnership is an increasingly important criterium for bio/pharmaceutical sponsors as they seek more bespoke solutions and the flexibility of tailored, blended outsourcing models.
DiPietro, M. Elaboration, Expansion, and Evolution in Outsourcing of Clinical Research. Pharmaceutical Technology 2023 47 (12) 31–33
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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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External controls can augment low populations in rare disease trials
Advantages and disadvantages of using historical controls, and how data can be analysed using Bayesian statistics to develop a ‘predictive understanding’ of a drug.
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Two-way street: US-Ireland business relations are mutually beneficial
CFO Brendan Brennan comments in this article from the Irish Times about the importance of the American market for Irish companies.
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Harmonising outsourcing to keep clinical trials on track
In this article in Applied Clinical Trials, Debbie Gilmore, Vice President, Strategic Alliance Management outlines how strategic partnerships and partnership-driven approaches to outsourcing can be used to navigate an increasingly complex clinical research landscape.
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The role of digital therapeutics in central nervous system clinical trials
In this article, ICON's Louisa Steinberg and Maureen Glynn consider the role of digital therapeutics in the treatment of central nervous system conditions and how they can be used to improve clinical trials.
