From MS to NMOSD to early Alzheimer's disease, neurologic mAbs are delivering proven clinical benefit. But as efficacy becomes less of a differentiator, what determines whether these therapies reach patients? In this art...
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ICON experts frequently author or contribute to industry trade press.
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Embedded and agile – The next phase of the DCT evolution
In this article, Darlene Ellenor Director of Project Operations, Decentralized Clinical Trials Operations highlights how DCTs are now considered a patient centric model for sponsors that want to enhance the patient and site experience and generate more robust data. As DCT evolves, an embedded approach backed by the right processes and tools will maximize the benefits that DCTs bring to clinical research.
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Supporting investigators and sites in the evolution to decentralised clinical trials
In this article from International Biopharmaceutical Industry, Harpreet Gill, Vice President of Real-World Solutions - Project Management reflects on how investigators and sites can be supported and partnered as the use of decentralised clinical trials evolves.
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Centred on decentralised trials: Q&A with Harpreet Gill
In this article on Pharmaceutical Executive’s website, Harpreet Gill discusses how DCTs can transform clinical trials and improve the patient experience.
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Keeping eCOAs off the critical path – key considerations
The prevalence of decentralised clinical trials and the importance of patient-centricity in medical practices are just two of many factors leading to the increased use of electronic Clinical Outcome Assessments (eCOAs). Digital devices like smartphones, tablets, wearables and web-based platforms are increasingly being used to measure the impact of a disease and/or treatment on patients’ quality of life and are an important way we can capture the patient’s voice in a clinical trial.
The eCOA system consists of the devices used for data collection, specialised eCOA software installed in these devices for collecting the data or access to web-based eCOA platforms and a centralised database or server to store, manage and analyse the data securely. This article explains how an optimised eCOA implementation strategy can minimise several risks and challenges associated with clinical trials.
Article published in International Pharmaceutical Industry, Volume 15 Issue 3, 29 September 2023
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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/).
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Clinical translation and linguistic validation at scale
Senior Vice President of Commercialisation & Outcomes, Brian Mallon, joins SlatorPod to shed light on the crucial role of language services within clinical research organisations.
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Regulatory considerations in technology for decentralised clinical trials
This article in the Journal of mHealth explores the guidance regulators have provided for diversity and inclusion in clinical trials, privacy considerations and endpoint selection, and is authored by Jo Hulbert, Executive Director, Global Regulatory Clinical Services with contributions from Arwa Shurrab, Senior Director, Global Regulatory Affairs and Priti Prasad, Senior Manager, Global Regulatory Affairs.
Copyright 2023 The Journal of mHealth (Simedics Ltd)
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Transforming clinical trials in a rapidly shifting landscape
Dr Ute Berger, President, Development & Commercialisation Solutions outlines how ICON is transforming clinical trials in a rapidly shifting landscape in the Executive Interview in Drug Development & Delivery.
Copyright Drug Development & Delivery.
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Boon and bane: dodging participant burden in decentralised clinical trials
As DCT adoption increases, Harpreet Gill, Head of Decentralised Clinical Trial Solutions at ICON contributes to this piece in Clinical Trials Arena which looks at how sponsors and CROs must mind the risk of adding patient burden while designing decentralised trials.
Verdict Media Limited 2022
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The evolving relationship between sponsors and contract research organisations
If the last few years have taught us anything, it’s that so much more can be achieved when all players in the life sciences and pharmaceutical industries work together in a truly collaborative way. The opportunity for the clinical development industry is to take what we have learned about how we can work together and use this to continue to drive progress. To strategically support clients, at ICON, this means partnering with sponsors in a way that goes beyond a traditional CRO. It means being a trusted partner.
In this podcast and article Jeff James, EVP Alliance Management, offers his perspective on what it takes to be a trusted partner to sponsors in the clinical development industry.