The effective monitoring of temperature throughout the supply chain is of paramount importance in ensuring the safe and protocol-compliant conduct of a clinical trial. This is of particular concern in trials that incorporate insulin, which must be kept in cold storage and within specific temperature ranges when not in use to maintain its specifications.
Temperature deviations have significant impact. Each deviation causes the progress of the product along the supply chain to grind to a halt as checks are conducted to make sure it is still suitable to be dispensed. This process can last days or even weeks, potentially leading to failed patient visits. While investigations of the excursion are conducted, additional product is often shipped - but as approximately 70% of the deviations are found to be still safe to use, this can go to waste.
This issue is compounded when the product is in short supply. "We have trials which are Phase I, where you do the first human dose," explains Lars Nobert, corporate vice-president of CMC clinical supplies at diabetes-focused pharmaceutical company Novo Nordisk. "The product might be scarce, so there's not so much product to discard."
Novo Nordisk has partnered with TSS, a provider of temperature monitoring solutions to the life sciences industry, to replace a paper-based system with the speed and efficiency of a digital approach. With all records online and immediately available, the new solution automatically responds to observations that the product is outside the intended temperature range. It supplants the manual process of deducting the time the product spent outside acceptable temperatures from the maximum time permitted at room temperature. "Prior to this it would take days to get this process and evaluate it, and now we're down to seconds," Nobert says. "So from a productivity, quality and delivery standpoint there's a huge gain and optimisation."
The new system works holistically to streamline the process of dealing with deviations. "It automatically aggregates all the information from the different parts of the supply chain into one universal truth," says Niclas Ohlsson, CEO of TSS. "It automates the notification and evaluation process so you remove all manual adding and analytics, and you get the right message to the right person at the right time."
The quality of data recorded by the digital system can also be used to drive refinement of the process. "We have a full view of the supply chain," Ohlsson says. "You can work on the fundamental parts that actually define the supply chain and improve it in terms of efficiency, cost and sustainability."
The new temperature monitoring system is the result of close collaboration between TSS and Novo Nordisk. "We designed the system with TSS, so we know for sure it will be easy to use, because we involved the people who are using it, both the site staff and our own staff," Nobert explains. Ohlsson emphasizes the importance of beginning with a client's brief rather than fitting a ready-made solution to a problem. "You put the business problem first on the agenda," he says. "From that, you use your knowledge and your capabilities and skills to develop the innovative or adapting emerging technologies to solve or improve these business challenges or needs."
TSS is focused on innovation for the benefit of the healthcare industry. "When the internet came, and then smartphones, everybody talked about one click," Ohlsson says. "We're trying to move towards zero clicks, to automate as far as we can: simplification, automation and integration mean that user involvement is reduced and the quality of data is so much higher."