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Are Cold Storage Problems Jeopardizing the Integrity of your Clinical Trials?

Are Cold Storage Problems Jeopardizing the Integrity of your Clinical Trials?

It’s no surprise that we here at Elemental Machines are strong supporters of scientific innovation. That’s why recent upward trends in the cost of drug development to over $2 billion  as well as times to market of over a decade just don’t sit well with us!  One area where there has been noteworthy cost increase is cold chain logistics. See Figure 1 for details. 

Cold storage and clinical trials- perosphere

Figure 1:  Increased costs for biopharma logistics can be attributed to the changing landscape of therapies. More cell and gene therapies (ie. biologics that are thermally sensitive) are under development. Source: CenterWatch  

Cold chain logistics are particularly important for validating the integrity of materials used in a clinical trial and thus clinical trial results. This is going to become increasingly important since the number of biologics on the market is expected to explode over the next several years. Many of the therapies or samples used in clinical trials are often time- and cost-intensive to procure or manufacture. Thus, it’s a no-brainer to invest in a simple, yet reliable temperature monitoring solution to prevent issues related to cold storage. 

The Elemental Machines IoT Connected Platform solution allows life sciences companies to effortlessly monitor its cold storage fleet, and in turn, the integrity of its clinical trial materials. It proved to be a worthwhile investment for a medical device company developing a novel coagulometer. The team discovered anomalous freezer behavior soon after installation of the system. One of the freezers used to store critical clinical trial materials exhibited regular temperature spikes of 15-20°C.  The temperature spikes often triggered temperature threshold alerts. They even occurred during evening and weekend hours, often when no staff was present. See Figure 2. The company team shared the Elemental Machines data with the freezer distributor to get to the root cause of the problem. So what was it? Well, you’ll have to read our User Testimonial to find out!

Perosphere - defrost cycle closeup

Figure 2:  Temperature profile for -20C freezer. The temperature often climbed into the alert region (above -10C and highlighted in red).

However, some major takeaways that we can share with you now are that within two weeks of deploying the Elemental Machines IoT Connected Platform, the medical device company identified a freezer performance issue and within a month, the manufacturer replaced the freezer that was not performing per specification.  Had the team not relied on the Elemental Machines Platform, the equipment anomaly may have gone undetected, thus compromising the integrity of the clinical trial materials. 

Learn more about how the this medical device company preserved the integrity of its clinical trial materials through temperature monitoring with the Elemental Machines IoT Connected Platform.

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