IN PARTNERSHIP
clinical trial administrator. In this way, InTempVerify provides the same data accessibility as USB loggers, while eliminating the user’s need to know who needs to receive the data, as well as eliminating the clinical trial administrator’s need to set up unmanageable numbers of permission-based user accounts. The InTempVerify app provides the maximum flexibility required to safely and automatically deliver critical temperature data on a particular shipment to the clinical trial manager, as soon as possible.
In current cold chain logistics set-ups, what kind of technology is primarily used in clinical trials for temperature-sensitive shipments? Because logistics companies provide pre- conditioned packaging to clinical trials sites, they are often the primary decider of which monitoring technology to use – rather than the actual clinical trial administrator. It is, of course, extremely important to the administrator to have a temperature overview of each shipment, from the pre-chilling of the packaging all the way to the patient at the end. Typically, the monitoring technology that’s used is the USB data logger, which records temperature data with a built-in thermistor. To configure a USB logger and download data, the user has to plug the data logger into a computer via a USB connection. Another alternative, the GPS logger, is not ordinarily used in clinical trials because it’s very expensive and distances are relatively short, so USB loggers are the ones commonly used. The logistics provider needs to ensure that packaging is within an acceptable temperature range before it reaches its ultimate destination, so the USB loggers are along for the entire journey.
How economical are USB loggers as an investment for pharmaceutical companies? In a sense, USB loggers are the lowest cost option available, but in terms of volume, Bluetooth data loggers are only nominally more expensive, if at all. Also, while a physical USB device might be inexpensive, when talking about economics, it’s important to consider how the data is retrieved at the end of the cold chain. Once the logger reaches its end-patient destination, the nurse at the home could read out the data, but would need a computer to connect to the USB logger. However, you wouldn’t expect the nurse to have to download a USB data logger, so what
60 | Clinical Trial Supply Handbook
“It is extremely important to the administrator to have a temperature overview of each shipment, from the pre-chilling of the packaging all the way to the patient at the end.”
happens is a driver takes the logger back to the clinical site, and sometimes it needs to be overnighted back to the logistics provider. So in most cases, with USB loggers, to get your data back to the clinical trial administrator, you’re talking 24 hours to get it back, so there is a time cost, as well as a logistics cost. That is the predominant technology out there.
What kind of innovative solutions can help supply teams operate more efficiently? The way Bluetooth loggers work, they can go right into the packaging and are all connected via the cloud and mobile apps or gateways, so they’re able to “talk” during the shipment. What really makes Bluetooth solutions beneficial is that a nurse can have a mobile app with different download permissions set up by clinical trial administrators, and whether it’s a tablet or mobile device, that nurse can just press a button, download data, and push it to the cloud. The clinical trial administrator receives that information immediately and can make actionable calls on the spot. And with InTempVerify, even the end patient can download the app, as there are no permissions required. Between the cloud and app, the system is intelligent enough to know the serial number of the logger and send the data up to the administrator account so decisions can be made right away.
Is InTemp technology suitable for all kinds of clinical packaging, labelling, and cold chain storage? Yes, because of the way the technology communicates. Some of our customers are larger shipping companies, and they’ve shown that our Bluetooth loggers are robust enough to communicate data right through the walls of shipping containers, so they’re certainly able to communicate easily and accurately through traditional or corrugated packaging.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92
