The Almac Clinical Services division of Almac group has launched Tempod 1000, a USB gadget designed to offer simpler, simpler seize, recording, storage and sharing of temperature data collected at websites throughout clinical analysis. The tool reportedly eases the executive burden of updating temperature logs manually, will increase site compliance with data reporting necessities, and promotes finest digital practices in trials and participant security.
According to the corporate, guide strategies of capturing temperature data have been difficult within the face of the COVID-19 pandemic. A excessive variety of websites are working below lowered hours, and even closing.
The Tempod 1000 is designed to automate the method of recording temperature data for drug merchandise saved at clinical websites. The gadget equips sponsors and CRAs with completely distant visibility, reportedly guaranteeing high quality and integrity of drug merchandise.
Manual strategies of data seize have proved difficult resulting from disruptions attributable to the worldwide pandemic. Many clinical websites are working lowered hours and, in some instances, closing. The Tempod 1000 automates the method by regularly recording temperature data for drug merchandise saved at clinical websites, offering sponsors and CRAs with full, distant visibility thereby guaranteeing high quality and integrity of the drug product.
Donna Christopher, international vice chairman of operations for Almac Clinical Services, stated the gadget suits properly with the corporate’s present temperature data choices.
“Tempod 1000 is an enhanced service for sponsors already benefiting from Almac’s Site Compliance module and TempEZ platform,” she stated. “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 gadget comes after the launch of Almac’s TempEZ web-based temperature data administration system. The module, paired with the Tempod 1000 gadget, is meant to create an end-to-end view of temperature data, demonstrating that merchandise have been saved throughout the label declare at every stage within the provide chain, together with at clinical websites (the place temperature excursions incessantly happen).
In addition, the corporate stories Tempod 1000 can scale back the danger of missed affected person visits resulting from unreported excursions, allow sponsors and CRAs to determine and resolve excursions remotely, speed-up CRA overview time throughout site visits and facilitate well timed and environment friendly examine close-outs and database locks.