Update

Almac launches site storage temperature module

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/4zevar)
(Image: Getty/4zevar)

Related tags: Almac, Clinical trial sites, Logistics, Temperature control

TempEZ is a web-based temperature data management software providing a single secure database to collect temperature data from clinical sites.

Almac Clinical Services, part of the Almac Group, the global contract development and manufacturing organization (CDMO), has added a Site Storage Temperature Compliance module to its TempEZ platform.

According to the company, the platform provides data visibility from manufacture to patient administration.

“In the world of clinical trials and GxP activities, without documented evidence of an event, you cannot confirm what has really happened,”​ said Donna Christopher, global vice president operations, Almac Clinical Services.

However, Christopher noted that investigational medicinal products (IMPs) spend more time at the clinical sites than in transit – and the majority of excursions occur at the site, she said.

“The challenge here is that the temperature data held by the sites is not readily available or visible for adjudication,”​ explained Christopher.

“Historically the industry focus has been on collecting transit data, but we need to shift our attention to improve how temperature data managed by the site is collected and stored.”

The new release addresses this challenge, Christopher said, as TempEZ digitizes any form of temperature data and makes it visible and available to sponsors and contract research organization (CROs). Clinical research associates (CRAs) also are able to remotely query the data.

Related topics: Clinical Development, Phase I-II

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