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February 8, 2023

Report

Mastering the translation of clinical trial labels

Without careful management, labeling can quickly become a significant bottleneck in the clinical trial supply chain, with any delays potentially derailing the progress of a study.

One of the most complex and lengthiest aspects of clinical trial labeling is efficiently managing the wide array of country-specific labels that are required for a multi-national trial, ensuring that all the label information is correctly translated and that the design and other label elements comply with the relevant local regulations.

Without the use of integrated systems, this activity is incredibly labor-intensive, and as trials get more complex and geographically diverse, it gets exponentially harder.

In this report we cover:

  • The translation challenge
  • Fundamentals of a GxP-compliant phrase library
  • Potential pitfalls
  • Embracing automation and creating a streamlined workflow with Loftware Prisym 360
  • Case study: How Prisym 360 allowed 48-hour turnaround of trial packs
  • SAP
  • Regulatory
  • GHS
  • Supply Chain
  • Clinical Trials
  • Artwork Management
  • Labeling
  • Track and Trace
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