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In this article from BioPharm International, Ronan Fox, Senior Vice President, IT R&D, provides commentary on the evolving role of automation in biopharmaceutical development.
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More than four years after decentralisation became a necessity in the clinical trials space, the sector is still finding its way around decentralised clinical trials (DCTs). And like any other paradigm shift, the journey has taken several turns.
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In this piece, Rosie Abbott explores how advances in technology have opened up many new opportunities and challenges in research, including the collection of biodata in remote studies. (see page 9)
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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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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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In this article on Pharmaceutical Executive’s website, Harpreet Gill discusses how and improve the patient experience.
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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 .
Article published in International Pharmaceutical Industry, Volume 15 Issue 3, 29 September 2023
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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 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 ().
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Senior Vice President of Commercialisation & Outcomes, Brian Mallon, joins SlatorPod to shed light on the crucial role of .
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This article in the Journal of mHealth , 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)