Clinical supplies & logistics
temperature The right
Temperature control can be the difference between a supply of usable products and a shortfall that delays a trial and increases the overall cost for sponsors. This level of risk demands greater supply chain visibility, and integrating temperature excursion management systems into a strategy with other elements of interactive response technology (IRT) can be an effective way to mitigate it. Monica Karpinski speaks to Jan Pieter Kappelle, senior supply chain strategist and advisor to the Bio Supply Management Alliance, Tom Schiavon, senior analyst for UAT and validation and clinical IRT, and clinical supply chain consultant Henk Dieteren, to better understand what is at stake, and how the combined approach can help trial organisers avoid pitfalls.
H
enk Dieteren remembers the days when retrieving a patient’s medication during a clinical trial meant phoning a system to ask
for their kit number. Then, it would be located and retrieved from a shelf in a similar fashion to sourcing a book in a library. This was an early iteration of interactive response technology (IRT), which today mostly uses cloud-based software to manage the patient randomisation and drug management aspects of a clinical trial – of which temperature control is a crucial element. With IRT, temperature excursions can
be monitored more closely, and necessary actions can be taken faster, or even automatically. For example, an IRT could upload a drug’s temperature data to a system for review so that it can be instantly released or quarantined, depending on the reading. But just as with cars, says industry expert and clinical supply chain consultant Dieteren, some models are better than others. Many of today’s IRT systems do include elements of temperature management, but there’s still a way to go in making these as effective as possible. For example, adds Dieteren, it is not yet
Clinical Trials Insight /
www.worldpharmaceuticals.net
17
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Shutterstock.com
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