How to navigate EU MAA Regulations and Registration Regulatory legislation in China differs substantially from that of the European Union. For Chinese biotech companies looking to enter this market it is critical to ass...
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Optimising biotech trial designs to stretch your cash runway
Brandon Early discusses how optimising trials designs at the earliest stages can help innovative biotech companies to maximise their available capital.
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As clinical trials face a hiring crunch, here’s how research organisations can pivot
Helen Yeardley, Senior Vice President, Global Clinical Operations, discusses how ICON is adapting to the global shortage of Clinical Research Associates in the industry.
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The significant increase in demand for Clinical Research Associates (CRAs)
Helen Yeardley, Senior Vice President, Clinical Operations, offers her insights on the role that a Clinical Trial Associate (CRA) plays in the clinical trial process.
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Pivotal time for CROs': ICON CEO Cutler on changing APAC trial trends
Steve Cutler and Atsushi Ogawa are interviewed in SCRIP where they discuss the increased opportunity for decentralised trials, in addition to the challenges and opportunities for clinical trials in Asia Pacific.
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Trial blazing
Harpreet Gill, Vice President, Decentralised Clinical Trials at ICON reflects on the progress that has been made in decentralised and hybrid clinical trials in the last number of years in this article in PharmaTimes.
January/February PharmaTimes
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Historical Controls in Rare Disease drug development: Using RWE to overcome key challenges
The following article will explore the advantages of using HCs, as well as several considerations for their effective use, including scientific methodology and regulatory
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Fortifying vaccines through disease surveillance and data reporting
In this article, McLendon explores the topic of fortifying vaccines against future pandemics.
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The power of partnership: Collaborating with patient advocacy organisations for better clinical research
Laura Iliescu explores the powerful potential of collaboration with PAOs for clinical trials, particularly how PAOs can inform trial design and the creation of patient registries.
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Life sciences sector remains strong in Ireland despite challenges
Brendan Brennan outlines the importance of collaboration between industry and academia in this article from the Irish Times Life Sciences special report.
2022 The Irish Times DAC
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Turning an ocean of data into actionable wisdom to support optimal site identification
Travis Caudill, VP Feasibility & Clinical Informatics, offers his insights on how advancements in AI can help the pharmaceutical industry identify the best sites for their clinical trials through the harnessing of Big Data.
Innovations in Pharmaceutical Technology, December 2022, pages 24-25. Samedan Ltd