CDMO Almac Clinical Services has announced the launch of the Site Storage Temperature Compliance module, the latest addition to its TempEZ platform. This component provides customers with a solution to digitise, visualise and manage temperature data held by the clinical sites.
TempEZ is Almac’s web-based temperature data management software. It provides sponsors with a single, secure 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.
The software gives clients data visibility from manufacture to patient administration, flexibility to utilise any brand of monitor, automated excursion management and it moves data from paper to computerised records.
The module is a welcome addition to Almac’s already established temperature management portfolio. The bespoke solution 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.
Donna Christopher, Global VP of Operations at Almac Clinical Services, said: “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.”
Christopher added: “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.”
The solution essentially closes the data gap which currently exists at clinical sites making temperature data visible and readily available.
