Building An Approved Phrase Library

The challenge of creating labels for investigational drugs is mounting as more countries sign on to participate in clinical trials. Delays in translating and approving clinical labels—a process that averages about 120 business days—can prevent clinical trials from starting on time and threaten to derail development timelines.

The issue boils down to one of process and priorities. Affiliates responsible for translating and approving labels often postpone the timeconsuming process to address other pressing matters, causing delays. Since translations are performed manually, inconsistencies and errors frequently result, the potential consequences of which can be more serious than merely having to correct or reprint the label.

A proven solution to the problem of label creation is the use of an approved phrase library, an electronic repository of globally consistent, multilanguage terminology that virtually eliminates the need for manual translation. With a single mouse click, the library automatically translates label text into multiple languages. Implementation of an approved phrase library has been shown to shorten label cycle times by more than 50%, improving clarity and consistency and reducing the workloads of clinical teams and affiliate staff.

As a global leader in clinical supply chain management, our Clinical Label Services team is setting the pace for improved translation management with the use of ATLASSM (Alternative Translation and Label Approval System). ATLAS—the only system available to address the full spectrum of label development, from text translation and approval through label manufacturing. This ebook discusses the challenges of translating and approving label text, and how an approved phrase library can reduce label timelines, improve quality, and assure regulatory compliance.