Almac Clinical Services, part of the Almac Group, has launched the Site Storage Temperature Compliance module to its TempEZ platform. This additional component allows customers to digitize, visualize and manage temperature data held by clinical sites.
 
TempEZ is Almac’s web-based temperature data management software that provides sponsors with a single database to collect the temperature data, required by GDP regulations, to prove their products have been stored within the label claim throughout the supply chain. TempEZ gives clients data visibility from manufacture to patient administration, flexibility to utilize any monitor brand, and it automates excursion management and moves data from paper to computerized records.

TempEZ’s Site Storage Temperature Compliance module was developed to reduce the data collection burden at clinical sites and to improve the visibility of temperature data held by the clinical sites for both clients and CROs. The solution aims to close the data gap that exists at clinical sites, making temperature data visible and readily available.

“Almac’s TempEZ is the only software platform that offers sponsors a complete, end-to-end temperature history of their drug product,” said Donna Christopher, global vice president Operations, Almac Clinical Services. “The focus for temperature data collection has typically been on transit data. However, drug products spend more time at the clinical site than in transit, resulting in the majority of temperature excursions occurring at the site. We need to focus our data collection efforts at this point to enable these excursions to be identified and adjudicated quickly, thus safeguarding the patient. In the current climate, sponsors have difficulty accessing temperature data held at the clinical sites. This release of TempEZ digitizes any form of temperature data and makes it visible and readily available to sponsors and CROs. In addition, CRAs can remotely query the data directly from TempEZ. I am delighted to announce the launch of our new functionality.”

Almac is exhibiting at CPhI North America at booth 1312.