Almac to improve label approval process in clinical trials
New system gives users full online review, amendment, traceability and control functionality
Almac Clinical Services has introduced a web-based clinical Label Approval System (LAS), which gives users full online review, amendment, traceability and control functionality regardless of geographic location.
The company says this 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 process 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 LAS has a number of key features, such as label proofs being automatically sent to predefined user groups and instant visibility to the status of all label approval tasks. Automatic email notifications are sent to designated approvers when labels are available. Users can also identify bottlenecks in the clinical trial label approval process for future improvements.
An online pdf mark-up brava reader tool clearly specifies changes to label design and multiple reports are generated.
Paul O’Connor, vice president of quality at Almac Clinical Services, said: ‘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. It 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.’
