The Almac Clinical Services division of Almac group has introduced Tempod 1000, a USB device designed to provide easier, more effective capture, recording, storage and sharing of temperature data collected at sites during clinical research. The tool reportedly eases the administrative burden of updating temperature logs manually, increases site compliance with data reporting requirements, and promotes best digital practices in trials and participant safety.
According to the company, manual methods of capturing temperature data have been challenging in the face of the COVID-19 pandemic. A high number of sites are working under reduced hours, or even closing.
The Tempod 1000 is designed to automate the process of recording temperature data for drug products stored at clinical sites. The device equips sponsors and CRAs with totally remote visibility, reportedly ensuring quality and integrity of drug products.
Manual methods of data capture have proved challenging due to disruptions caused by the global pandemic. Many clinical sites are operating reduced hours and, in some cases, closing. The Tempod 1000 automates the process by continually recording temperature data for drug products stored at clinical sites, providing sponsors and CRAs with full, remote visibility thereby ensuring quality and integrity of the drug product.
Donna Christopher, global vice president of operations for Almac Clinical Services, said the device fits well with the company’s current temperature data offerings.
“Tempod 1000 is an enhanced service for sponsors already benefiting from Almac’s Site Compliance module and TempEZ platform,” she said. “It will save time and resource through automated collection of temperature data at the clinical sites.”
“Not only will this relieve the pressure on site staff, but it also provides audit-ready temperature history that can be accessed remotely by the sponsor or CRAs,” Christopher added. “Almac is committed to digital transformation and recognizes the value of replacing manual, paper-based processes.”
The introduction of the Tempod 1000 device comes after the launch of Almac’s TempEZ web-based temperature data management system. The module, paired with the Tempod 1000 device, is intended to create an end-to-end view of temperature data, demonstrating that products have been stored within the label claim at each stage in the supply chain, including at clinical sites (where temperature excursions frequently occur).
In addition, the company reports Tempod 1000 can reduce the risk of missed patient visits due to unreported excursions, enable sponsors and CRAs to identify and resolve excursions remotely, speed-up CRA review time during site visits and facilitate timely and efficient study close-outs and database locks.