Almac Clinical Services, part of global CDMO the Almac Group, has launched Tempod 1000 which bolsters the company's site compliance and temperature management offering for sponsors.
An extension to Almac's established temperature management service, Tempod 1000 is a USB device that captures and stores all clinical site temperature data and automatically identifies unreported excursions once uploaded into TempEZ. Designed to remove the administrative burden of updating manual temperature logs, it also increases site compliance with reporting data and promotes best digital practice in clinical studies and patient safety.
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.
"Tempod 1000 is an enhanced service for sponsors already benefiting from Almac's Site Compliance module and TempEZ platform," said Donna Christopher, Global VP of Operations for Almac Clinical Services. "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. Almac is committed to digital transformation and recognises the value of replacing manual, paper-based processes."
Tempod 1000 follows the recent launch of the Site Compliance module of Almac's web-based temperature data management system, TempEZ. The module, combined with Tempod 1000, is another step closer to our goal to digitise, visualise and manage the temperature data held by clinical sites. This will create an end-to-end view of temperature data within TempEZ and demonstrate products have been stored within the label claim at each stage in the supply chain, including at clinical sites where most temperature excursions occur.
In addition, Tempod 1000 will 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.