Company insight The next step to automating clinical trials
TSS has spent the past 20 years working with some of the world’s leading pharmaceutical companies to help them deliver drugs safely to patients. When it comes to ensuring patient safety in clinical development, temperature management is critical, but the industry continues to use legacy point solutions that require heavy manual processes and duplication of data. However, there are new solutions that digitise manual processes, resulting in reduced site burden, timely kit-level data for study teams and ensuring safe delivery to the patient.
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,” says Evan Hahn, VP of TSS North America, suggesting that companies offer similar solutions for clinical and commercial distribution streams when their requirements are ultimately different. It comes down to the last mile. With a standard commercial supply chain, there is a repetition of processes that leverages standardised distributors for bulk shipments and where responsibility for last-mile temperature resides with third parties.
“Y
ou can say that if you meet all the needs of clinical, you would meet all the needs
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,” says Tobias Holmer, CPO at TSS.
RTSM/IRT providers have identified integration and visibility as key elements that assure of the integrity of the product. “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
“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 minimising site burden.”
Evan Hahn, TSS North America Unique challenges
Clinical trials are different. While the initial stages of the supply chain are similar, sponsors are responsible for the entire chain of custody – relying on manual intervention at clinical sites to ensure compliance. This increases risk, with direct-to-patient studies in particular presenting unique challenges. “Direct-to-patient studies were already trending upwards and have accelerated with Covid-19. We need to support that
Clinical Trials Insight /
www.worldpharmaceuticals.net
Hall, VP of clinical innovation and quality at Endpoint Clinical. Without these integrations, something as simple as a fridge door being left open can result in treatments administered to patients without the awareness that they’ve been compromised. However, it’s going to take some radical thinking to bring the same level of innovation to clinical distribution as it 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 minimising site burden,” says Hahn.
The whole process
When the line of sight into temperature data is lost, so is control of the study, which often happens when a manual element into the process is introduced. Automation and tight technical integration are 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,” confirms 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 general commercial supply chain. It’s designed to work seamlessly 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, which can be trusted. ●
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