Almac Launches New STEMS System to Transform Temperature Controlled Shipment Monitoring in Clinical Trials
Product News Feb 18, 2010
“Almac Clinical Services marked the start of 2010 with the official launch of a new state-of-the-art web-based, Shipping Temperature Electronic Monitoring System - stems. Unique to the pharmaceutical and biotech industries, this latest addition to the Almac services portfolio is set to revolutionise the management of temperature controlled shipments within the clinical trial industry. ‘
Temperature excursions can inhibit the clinical supply chain, resulting in crucial investigational products being delayed or quarantined and not made available for immediate use at the study site. Excursions can occur at any point in a global supply chain and often arise as a result of multiple uncontrollable factors
Upon download, Almac’s Shipping Temperature Electronic Monitoring System – stems, equips clinical supply professionals with immediate visibility over all crucial shipment temperature reports. This enables users to make instant decisions 24/7 on their clinical supplies without the need for monitor returns or faxing of results.
Stems reduces any quarantine time for clinical supplies at study sites, saving both time and money for a global clinical study.
stems is the latest addition to the Almac services portfolio for temperature controlled clinical supplies. Alongside the Group’s Specialist Temperature Controlled Team, and customised shipping unit systems, this new technology delivers the following key features:
• 100% shipping temperature reports - allowing root cause analysis for process improvements saving time & financial resources in large global trials
• Instant reporting enabling near zero quarantine time – improved inventory management whilst saving time and reducing costs
• Fully-validated system – compliant with 21 CFR Part 11 requirements
• No return shipments required for devices, saving time and reducing expenditure
• Fully compatible with a range of browsers and requires little training
• Automated email notifications sent to predefined users
• Complex multiple alarm system programmed to match drug temperature requirements
This latest launch also coincides with a new Label Approval System (LAS) – a unique workflow-based label approval management system. LAS gives users full online review, amendment, traceability and control functionality regardless of geographic location.