Almac Launches New STEMS System to Transform Temperature Controlled Shipment Monitoring in Clinical Trials

Novel technology saves time and reduce costs in clinical studies

“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:

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 requirement

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.

Martin Lamb, Vice President of Global Business Development, Almac Clinical Services commenting on the launch of the new system: “I am delighted to announce the launch of our new Shipping Temperature Electronic Monitoring System – stems. We have experienced rapid growth in the volume of our controlled temperature shipments in the past few years. Improving visibility and performance in this area is a key goal for Almac, our clients and regulators alike, so the introduction of new, innovative tools has been a core part of our business strategy. By helping our clients achieve these goals, stems will be of major interest to Pharmaceutical and Biotech clients.’

Contact:

Aileen Murphy

E: [email protected]

Tel: +44(0)28 3836 2436

About Almac

Almac is a financially stable, privately owned organisation with over 30 years experience, it provides integrated development solutions to over 600 customers worldwide including all the world leaders in the pharmaceutical and biotechnology sectors. Their services include R&D, translational genomic services; API manufacture; formulation development; clinical trial supply and technology (IVRS/IWRS/ePRO) and commercial-scale manufacture.

The company has over 2,600 employees and is headquartered in Craigavon, Northern Ireland, where it was awarded “Business of the Year 2009”.  US operations are based in Pennsylvania, North Carolina and California.  Construction of the company’s new $112m North American Headquarters in PA started in July 08 and will be completed in 2010.

For more information about the Almac Group, please visit almacgroup.com or e-mail [email protected]