What exactly does Internet of Things signify?
The term “Internet of Things” was coined by Kevin Ashton, an internet pioneer, in 1999. He stated that today´s computers would still be heavily dependent on humans for informational input. It would be the next step of technical evolution to enable computers to think and act for themselves:
We need to empower computers with their own means of gathering information, so they can see, hear and smell the world for themselves, in all its random glory. RFID (radio-frequency identification) and sensor technology enable computers to observe, identify and understand the world—without the limitations of human-entered data. (Ashton, 2009, par. 4)
State of the art in clinical trial logistics
As for now, data that reveals whether the IMP (investigational medicinal product) has been transported safely and sound is revealed only at the end of the supply chain. So only at the depot it gets clear, if there have been temperature or humidity excursions on the way from the manufacturer. Only when the IMP arrives at the clinical site it can be checked whether its journey from the depot was safe. The patient´s home has been a complete black box in clinical trials anyhow.
In short, the missing link is the data-logging when medication is underway; between manufacturer, depot, clinical site and patient´s home. But: These are precisely the most critical links in the supply chain, because it is here, that temperature or humidity excursions most likely occur. This means if an IMP gets ineffective on its way, replacement can only be ordered, when the damage has already occurred and precious time is lost.
Why Internet of Things is relevant for clinical trial logistics
Internet of Things (IoT) could help to revolutionize procedures in clinical trials logistics. It could bring light to the, at present, blank spots in logistics. It can make visible all relevant logistics data: temperature, humidity, geolocation, access, shock, light any time to all parties involved. Be it manufacturer, 3LP, CRO (clinical research organization), CMO (clinical management organization) and so forth – they all can access this data and react in real-time and proactively upon all difficulties that might occur. Risks for the patient´s safety can by this means be reduced as well as costs on the manufacturer´s and logistics provider´s part. The latter can optimize the supply chain based on the aggregated data. Internet of Things, besides, is the answer to the ever stricter regulatory demands such as the GDP (Good Distribution Practice):
It is the responsibility of the wholesale distributor to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity.(GDP, par. 8.2)
IoT also gets even more relevant against the backdrop of a growing number of temperature sensitive biopharmaceuticals: According to the International Federation of Pharmaceutical Manufacturers & Associations 2014 (IFPMA) biologicals make up 36% of the late-stage pipeline and 45% of the late-stage oncology pipeline. This demands for highly specialized, intelligent biopharma cold chain logistics that can answer to the complexity of the cold chain.
The Internet of Things is gradually building into the cold chain logistics of clinical trials. IoT has already disrupted other industries for the better. It is only a question of time when the Internet of Things will be business standard in cold chain logistics.