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From the editor On the web...


Keep up with the latest developments in the pharmaceutical industry by visiting www.worldpharmaceuticals.net


Clinical Trials Insight Volume 2 2024


Editorial


Editor Phoebe Galbraith phoebe.galbraith@btmi.com Sub-editor Pete Barden Group art director Henrik Williams Designer Martin Faulkner Production manager Dave Stanford


Commercial Client services executive Derek Deschamps


Sales manager Nathan Park nathan.park@btmi.com


Clinical Trials Insight is published twice a year by Business Trade Media International.


Registered in England No. 06212740. www.worldpharmaceuticals.net ISSN 2050-3067 © 2024


All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner.


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elcome to this edition of Clinical Trials Insight, where we delve into the transformative developments shaping the clinical trials industry. As innovation and collaboration take centre stage, the evolving regulatory landscape, data integration, and digital tools are redefining how trials are designed, conducted, and managed. In this issue, we explore the Accelerating Clinical Trials in the EU (ACT EU) initiative, which has launched two new advice pilots aimed at improving the quality of clinical trial applications. As Europe seeks to strengthen its foundation for developing safe and effective medicines, we explore how these pilots will guide researchers through the technical and regulatory challenges of this new regime on page 6. We are also witnessing a shift towards digital solutions that promise to enhance clinical trial efficiency and success rates. From generative AI to digital protocols, these tools are transforming trial design and execution by streamlining processes and enabling smarter decision-making. On page 24, we consider the potential of these cutting-edge approaches and their implications for the future of clinical trials. In today’s data-driven world, clinical trials are becoming more complex, with data management, biostatistics, and standardisation playing critical roles in driving transparency and efficiency. However, the fragmentation caused by siloed processes and external vendors poses significant challenges. We speak to experts to uncover strategies for breaking down these silos and ensuring robust data integrity on page 31.


Driving innovation and collaboration W


As the clinical trials industry evolves at an unprecedented pace, embracing innovation while maintaining collaboration across stakeholders remains key to navigating this dynamic landscape. As we delve into the latest insights in the industry, I hope you enjoyed the latest edition of Clinical Trials Insight.


Phoebe Galbraith, editor


Clinical Trials Insight / www.worldpharmaceuticals.net


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