Almac to Improve Label Approval Process in Clinical Trials

Almac Clinical Services continue to showcase innovative technology with the launch of their new web based clinical 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.

This is the latest addition to the Almac Clinical Services portfolio in improving the overall clinical label approval process. Traditionally manual in scope and highly labor intensive this system development will automate the approval process and speed up the time taken to generate labels for investigational products. It will ensure all steps involved in the label approval are easily visible, traceable and actionable to users – eliminating the need for reliance on e-mail, fax and hard copy, thereby speeding up the editing process. The system includes multiple reports so users have full traceability for reviews, edits and approval allowing them to identify any bottlenecks in the label approval process and improve the overall efficiency of clinical label generation.

Key Features

The Label Approval System (LAS) has a number of key features that will enhance the overall label approval process allowing the seamless coordination of approvals among multiple approvers.

• Label proofs are automatically sent to predefined user groups
• Users have instant visibility to the status of all label approval tasks
• Automatic email notifications are sent to designated approvers when labels are available
• Identify bottlenecks in the clinical trial label approval process for future improvements.
• Online pdf mark-up brava reader tool to clearly specify changes to label design
• Automatic notification of ‘late’ tasks
• Generate multiple reports – adding transparency
• Current Status Reports – “What labels are with Almac & affiliates and for how long?”
• History Reports – “Who did what in a specific time period”
• Label Lifecycle Reports – “How long did the design, approval, changes take per label?”

Paul O’Connor, Vice President of Quality, Almac Clinical Services commenting on the launch of the new system said ‘ I am delighted to announce the launch of our new Label Approval System – we have invested significantly in the development of this new system which is the latest in a series of process improvements to remove bottlenecks in the clinical supply chain. This latest offering to our service portfolio range will be of major interest to our clients within the Pharmaceutical and Biotech industries who are seeking faster routes to get their drugs to market.’

This latest launch also coincides with the launch of a new web based Shipping Temperature Electronic Monitoring System – stems. Upon download, 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 to monitor returns or faxing of results. Testimony to the Almac’s Groups commitment to innovation and looking for alternative methods to exceed their client expectations.

If you would like further information on the system or would like to view a demo please visit www.las.almacgroup.com.

Contact:

Aileen Murphy

[email protected]

Tel: +44(0)28 3836 2436

More Images can be viewed at the following link: http://www.flickr.com/photos/almac_clinical_services/

About Almac

Almac is a financially stable, privately owned organization 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 $120m 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].