Almac to Improve Label Approval Process in Clinical Trials
News Apr 01, 2010
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 labour 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.
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 for monitor returns or faxing of results.Testimony to the Almac Group’s commitment to innovation and looking for alternative methods to exceed their client expectations.