It's fair to say that effective handling of temperature sensitive products throughout the supply chain is crucial for clinical trial success. It is also a key factor in the successful management of the commercial supply chain, and the reasons for that are simple; if products are not kept at the optimum temperature, huge amounts of money can go down the drain. Clinical trials, in particular, can be greatly affected by only the smallest change in temperature, meaning supplies can go to waste, potentially altering participants' treatment if new shipments don't arrive on time.
Against this backdrop, regulations for temperature sensitive products are constantly changing becoming tighter and tighter. Furthermore, concerns over ambient products are increasing the amount of monitoring required for each product - increased monitoring equals increased costs. Throughout this article, I will look at how to successfully integrate temperature monitoring systems with IRT (Interactive Response Technology) while discussing the advantages of incorporating it into your trial.
To skim over the basics that are required when you are not using IRT - all shipping boxes for products in clinical trials have a temperature monitor inside. Once each box has been opened, site staff are typically required to stop the temperature monitors, check for any alarms, and upload the monitor on to the respective web page. The sponsor is then alerted and analysis can be carried out to check the temperature has been properly recorded and, crucially, the supplies have not been altered.
Nevertheless, this is not always the case. Oftentimes, only one or two boxes are checked by investigational staff on site and the rest are presumed to be the same. What's more, sometimes the temperature monitors are taken out of the box but aren't checked for alarms, or they aren't uploaded correctly to the web page. This can ultimately put the patients in your trial at risk, grinding your trial to a halt - which can be detrimental to your product.
This is where IRT can come in handy with the potential to make or break your clinical trial/supply chain. IRT systems are able to send alarms to the sponsor automatically and therefore trial staff can react imminently and send more supplies. Not only can IRT record data and send out alarms automatically - they have the potential to adapt and change the environment of the shipping boxes, so if a temperature excursion occurs, the supplies can be saved - therefore saving a great deal of money, as well as your clinical trial.
There are multiple advantages of using IRT with a temperature monitoring system. For one, the investigational site staff and the sponsor are alerted about missing temperature data promptly and can take appropriate actions in a timely manner. What's more, analysis of temperature excursions can be made readily available earlier and therefore supplies can be sent accordingly. So as you can see, the use of IRT systems has the potential of ensuring the subject's treatment isn't disrupted and that their safety is not affected.
Ultimately, if IRT is developed to its full potential and used effectively with monitoring systems in the supply chain, there should be no deviations in temperature and supplies going to both clinical trial sites and to commercial depots should be valid - in theory...