Could automating temperature excursion management hold the key to improving clinical supply processes?

There are a few key reasons why many sponsors are starting to ask whether current clinical supply processes are efficient enough.

Particularly when it comes to temperature excursion management, the current industry standard has several limitations.

Automating temperature excursion management

Digitalization and innovations in technology mean companies in every sector have more visibility and traceability of their processes than ever before. From HR to manufacturing, the automation of manual processes is not only saving time and money but allowing for seamless monitoring and enhanced business intelligence too.

But temperature excursion management is trailing behind. The issue of quarantined products due to short temperature intervals outside of allowed ranges is an important example of this.

The debate around new technologies

Despite most temperature excursions falling within pre-defined stability budgets, they trigger a quarantine while a time-consuming and inefficient manual review is conducted. This means that although the majority of quarantines do not result in wastage or replacement, QA and site staff are still required to complete a lengthy and time-consuming manual process of sharing data, compiling drug histories, calculations and reviews.

Automation, cloud and IoT technologies hold the key to making this crucial part of clinical supply processes more effective. It removes the need for these manual steps by providing seamless monitoring of every stage of the distribution journey.

Integrations are a must

Over 8,000 sites and 18,000 users are now automating the review process using the TSS Clinical Module, helping reduce quarantines by over 90% while eliminating the associated efforts and delays while ensuring that treatments are safe and available for patients.

By unlocking the potential of IoT, it becomes much simpler to upload temperature data from a range of devices through the clinical supply chain. Automation and seamless monitoring ensure there are no data gaps from manufacturing to dispensing, while any excursions and deviations are identified and communicated in seconds.

The TSS Clinical Module also offers 100% bi-directional integration with IRT systems, allowing for the automation of quarantine and release. By integrating with the eClinical infrastructure, this solution is not only automating manual processes but ensuring the safe delivery of treatments to patients.

Embracing change

Solutions that utilize the automation of temperature excursion management are no longer an unproven and potentially risky gamble for clinical sites. In fact, solutions like the TSS Clinical Module are already helping thousands of sites in over 60 countries to make their processes more efficient. Full traceability and visibility of the drug shipment process is no longer a pipedream. For a growing number of sites, it is the reality.

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