Temperature management is critical when it comes to ensuring patient safety in clinical development, but we continue to use legacy point solutions that require heavy manual processes and duplication of data. However, there are new solutions that digitize manual processes, resulting in reduced site burden, timely kit level data for study teams, and ensuring safe delivery right to the patient.
“You can say that if you meet all the needs of clinical you would meet all the needs of commercial, but you can’t say the inverse – you can’t say that if you meet all commercial needs, you’d satisfy all the regulatory requirements of a clinical setting.”
So argues Evan Hahn, VP of TSS North America, making the point that perhaps we’re guilty of offering similar solutions for both clinical and commercial distribution streams when their requirements – although they share certain elements – are ultimately different.
It all comes down to the last mile. With a standard commercial supply chain, there is a repetition of process, a process which leverages standardised distributors for bulk shipments and where responsibility for last mile temperature resides with 3rd parties. Clinical trials are different. While the initial stages of the supply chain remain similar, sponsors are responsible for the entire chain of custody – relying on manual, human intervention at clinical sites to ensure compliance. This lends to increased risk, with Direct to patient studies in particular presenting unique challenges.
“Direct to patient studies were already trending upwards and have accelerated with COVID. We need to support that and ensure safe delivery of medication in that sort of study environment. The ability to handle Bluetooth, IoT and direct bidirectional communication with RTSM/IRT solutions within our cloud platform can help ensure safe delivery and temperature compliance” affirms Tobias Holmer, CPO, TSS.
RTSM/IRT providers have identified integration and visibility to key elements that provide assurance of the integrity of the product as paramount.
“Integration with IRT systems is going to be key, automating that critical final stage of the process. The aim is to get total transparency of process from manufacture to the patient ingesting a drug, with any excursion automatically logged and communicated to the IRT systems.” says Cat Hall, Vice President of Clinical Innovation and Quality, Endpoint Clinical.
Without these integrations, something as simple as a fridge door being left open can result in treatments being administered to patients without awareness that they’ve been compromised. But it’s going to take some radical thinking to bring the same level of innovation to clinical distribution as is applied elsewhere:
“One aim is to take the innovative mindset that’s inherent in biopharma discovery and the amazing ways that they drive science…and apply it to distribution, ensuring safe delivery of each kit, while minimizing site burden” suggests Evan Hahn.
When we lose line of sight into temperature data, we lose control of the study – and this most often happens when we introduce a human, manual element into the process. Automation and tight technical integration is key to increasing the rate of successful outcomes, while also speeding up the whole clinical process.
“In clinical trials, temperature visibility of every dispensed kit becomes essential. And the tools exist to facilitate this, including automating the calculation of stability budget to separate excursions within the stability budget and those that are deviations and prevent dispensation…”, affirms Evan Hahn.
TSS Clinical Module was built in collaboration with pharma companies in recognition of the specific needs of clinical trials – needs that differ from the more general commercial supply chain. It has been designed to seamlessly work with RTSM systems and is an embodiment of TSS’ ‘technology agnostic’ approach.
This approach is hugely flexible in the way it incorporates temperature data, allowing solutions from multiple vendors to be easily integrated into the system and accommodating the variance of trial sites, whether they be manual, USB, or IoT.
The result? End-to-end monitoring of the entire supply chain that you can trust.