The shipping temperature electronic monitoring system (STEMS), as the name suggests, logs the temperate of trial materials as they move through the supply chain until they reach their destination trial site.
This data is then uploaded to a centralised, web accessible database allowing Almac and its customers to instantly determine if the materials can be used or if their temperature was outside limits at any point during transport.
This capability, as Almac project group manager Nathan Kohner explained, is designed to meet growing customer and regulator demand for rapid communication of shipping temperature data.
Kohner told Outsourcing-pharma that: “Clients were requesting confirmation of the results of every shipment as soon as possible. Any delays in clinical trial shipping can be critical so every minute is precious.
He said that, unlike other monitoring systems in which data is transferred via email before being complied into a final report, STEMS feeds its information into a central resource for instant analysis and processing.
For clinical trials, Kohner added, such instant access is a real advantage, particularly for studies at multiple locations which, at present, must quarantine clinical supplies until they have sent temperature data for collation and review.
He explained that: “Retrieving and compiling the temperature results can take anywhere from two days to two weeks for really remote sites with current common systems.
“Stems can reduce the time between shipment delivery and temperature report review to just minutes meaning virtually no quarantine time at the site. This is a big step forward in clinical trial shipping.”
Kohner also suggested that the system and analysis of the data it records will improve the design of shipping practices and provide the opportunity for the development of customised solutions for specific products.
He explained that although temperature mapping of supply routes has been done in the past “The stems systems will integrate the monitoring of global air routes into the live process and over time build up a detailed data set of world wide shipping conditions.”