Almac to Improve Label Approval Process in Clinical Trials

April 1, 2010

Company News Release

Almac Clinical Services has launched their web based clinical Label Approval System – LAS a workflow-based label approval management system. LAS gives users full online review, amendment, traceability and control functionality.This is the latest addition to the Almac Clinical Services portfolio.

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

-          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 launch also coincides with the launch of a new web based Shipping Temperature Electronic Monitoring System – stems.