Labelling

Information is power. In human clinical trials, the product label is the source of that power – it's the voice of the product and it needs to speak clearly throughout a highly complex process.

Effective labelling will be strong both visually and practically – a good label will remain clearly legible at all times and also firmly affixed in a variety of different temperatures.

Labelling needs to be innovative incorporating new approaches such as 2D QR barcodes, for example, to stay ahead of a constantly evolving, fast-moving industry.

There is huge, careful administration required in their production – a labelling mistake could have critical repercussions for project and patient.

But the devil, as they say, is in the detail and it’s here that the true complexity lies.

Regulatory requirements must be met. Regulatory agencies include local governments as well as major bodies such as the FDA, the EU, the CFDA etc. and each have their own specifications for the content and presentation of labels from sponsor details to dosage, from codes to font sizes.

The increased globalisation of clinical trials means, too, that there is more need for multilingual labelling in international drug delivery – something that COREX Logistics understands only too well as a company that operates in over 80 countries.

There are a number of ways to tackle this challenge. One option is to create a region-specific drug label with matching regulatory requirements using a dominant language and subsequently localizing and translating it into the languages of the individual member countries of the region as a whole.

Expanded-content labels (ECL’s) that fold out, accordion-style, or peel back, can contain all of the required information, in many different languages.

Another option is to use booklet labels, now available in up to 113 pages. These provide an all-purpose solution for every country, accommodating all languages in a clear structure.

Whatever method is deemed to be the most effective in any given case, it’s worth remembering that labelling is complex, ever evolving and crucial to the safety and efficacy of trials. At COREX, we stay ahead of changes in technology, and client and regulatory requirements and always remember that the patients at the heart of every trial deserve the best, most diligent care.

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