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Staying Ahead of the Curve

In the grand scheme of clinical trial planning, labelling processes may seem insignificant in comparison to obvious fundamentals such as drug manufacturing, securing funding, or patient recruitment. As clinical packaging is typically approached sequentially (manufacture, package, label, ship), it is unsurprising that labelling is usually only properly considered and defined during the latter stages of the process. It is just a label after all, right?

Wrong. A label is the first thing a patient – and a regulator – will see when they receive a kit. A label is also vital in the bid to obtain approval in countries where a trial is operating. With the American Journal of Health citing that incorrect labelling is one of the top five reasons for drug recall in the US, it is time we acknowledge the real role labelling plays in the bigger picture of a clinical trial’s success.

Clinical trials are changing rapidly, and this is having a big impact on labelling processes, which need to evolve to meet increasingly complex criteria. Labels are no longer used as a basic table of contents, but they need to be multifunctional and used to deliver variable information in different formats and languages. The core drivers for change can be grouped into four categories: the emergence of biologics products, growth in global trials, increased regulation, and adaptive trials − each bringing its own set of labelling challenges.

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James McAleavey graduated from Queen’s University Belfast, UK, with a BSc honours degree in Mathematics and Computer Science. James joined Almac Clinical Services in 2002, having previously worked within the labelling industry for almost 10 years. As part of Almac’s global label services team, he is a subject matter expert on the challenges of the regulatory and design aspects of labels within a clinical trial and the key role they play in ensuring successful study and patient compliance. He has extensive experience in the auditing of label manufacturing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations.
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James McAleavey
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