Signant Health has introduced its complete, cloud-based Temperature Excursion Management (TEM) platform within its clinical supply chain management solution portfolio.
A standalone module, the TEM solution aids in the end-to-end tracking of the temperature excursion of an investigational product, from manufacturing through to supply and clinical trial sites.
Careful monitoring of the environmental conditions to which investigational products are exposed to in the course of storage and handling is necessary to support their quality and safety.
The automated platform also aids the sponsors in collecting, combining, reviewing, assessing, and adopting actions depending on the temperature monitoring data gathered at each stage of the production and distribution process.
This removes the manual assessment processes that are time-consuming and prone to errors.
Customisable integration options and automation enables sponsors and research sites to monitor temperature excursions for all clinical trials from one user interface while producing a complete genealogy, as well as an improved audit trail for the respective product unit.
The solution integrates with the new edition of the Planning, Materials and Distribution (PMD) solution of the company.
It is planned to be completely incorporated into the Signant SmartSignals RTSM solution next year.
Signant supplies management solutions vice-president Oliver Cunningham said: “The addition of the Temperature Excursion Management solution into our supplies inventory management platform enables customers to track cumulative temperature excursions against a library of electronic stability profiles.
“They can also verify that temperature monitoring devices are launched and packed within the same workflow they use to pick and pack their patient supplies.
“By simplifying and accelerating these processes for customers, we enable end-to-end visibility into clinical IP temperature excursion history while supporting patient safety and full GxP compliance.”
In July this year, the company made improvements to its Randomization and Trial Supply Management platform for directly delivering clinical supplies to the homes of patients.