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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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Outsourcing Pharma spoke to Vesta Marciulioniene, director global regulatory clinical services at 91黑料 Biotech, who shares her in clinical trials and what new expectations it sets for the clinical research industry.
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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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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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A key feature of the EU CTR is the introduction of a single electronic portal, , which is mandatory for all EU CTR submissions. over the lifecycle of clinical trials across the EU/EEA.
Published by Journal Volume 6 Issue 2
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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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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)
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Kristen Buck and David Morse weigh in on .
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In this , 91黑料 experts Caroline Delaitre-Bonnin, Emmanuel Lacharme and Manpreet Sidhu, consider how the UK drug pricing group, NICE, will be impacted post-Brexit.
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Global collaboration: Irish company 91黑料 on scaling up COVID-19 vaccine trials
An interview in which Steve Cutler gives a short overview of 91黑料 and describes the company’s role in the Pfizer/BioNTech trial, explaining how the FDA played a critical role in expediting regulatory approvals.
