We can all agree on what clinical labelling looks like today – a small paper that appears on investigational products detailing the information determined by the stringent regulations of the pertinent country. This format is not without issues. How does one fit all the regulatory required information on a paper the width of your finger? What happens when information requires updating? Why should information be repeated for the same product on all packaging? The list continues.
Last week, TransPerfect Life Sciences attended Arena’s Clinical Trial Supply Conference in Milan to find out how clinical labelling is developing and, equally important, when we can expect to see these changes.
The ‘Push’ for E-Labelling
E-labelling is not a new concept – the term has been used for more than ten years now without much progression towards the industry adopting it fully. The idea of moving from a physical label in favour of a virtual label does correspond to the way that other industries are going. Indeed, this would resolve many of the current issues that arise with the paper-based format. Although, with e-labelling raising whole new problems of its own – not least of which is presuming a certain tech-savvy patient – we can understand why people are reluctant to make the leap.
However, it does seem that now e-labelling is not just a notion better suited to science fiction but an attainable reality. There has been a noticeable ‘push’ towards the industry adopting it as the new norm.
For instance, GS1 – the non-profit organisation that develops 2D barcodes – has been working towards creating a barcode suited for the clinical world. GS1 formed a work group of medical professionals to drive towards creating a usable clinical e-label. Equally, GS1 has created standards for clinical labelling to ensure that the transition to this virtual format is as smooth as possible. In fact, certain members of the original work group have begun to try this new process with their upcoming trials.
All that remains now is for the industry as a whole to put this into practise…
The Introduction of E-Paper/E-Ink
If not ready to make the change to e-labels quite yet, alternate solutions have become available to take us partway.
E-ink or e-paper is a good example of this. This technology allows for certain fields to be updated from afar. For instance, let’s say that the re-test date changes over the course of a clinical trial; due to the limitations of our current paper-based labels, such a change would involve the re-labelling of all products. The idea that this could be done remotely would save both cost and precious time, driving operational efficiencies.
Either way, whether the clinical label of the future appears tomorrow or in years to come, TransPerfect Life Sciences is staying informed of the situation and is ready for what’s next.
For information on how we can support regulatory review, translation and workflows for clinical labelling, please don’t hesitate to reach out to email@example.com.