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Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

With increasing numbers of clinical trials operating across multiple territories, it has never been more important to ensure medicines meet different local language requirements. PRISYM ID’s Mark Cusworth explains how label management software can help organizations make sense of the complexity. 

Now more than ever, the clinical trials’ landscape touches more regions than ever before. As a result, new studies are grappling with the challenge of managing variable local language labeling requirements. 

All information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them. Yet the challenge is not only about how to translate phrases into multiple different languages but also drill down to a highly local language level to ensure the instructions and information provided are understood precisely.

The demand placed on a label management system is significant. It includes managing the translation of individual phrases, bulk translations import, specific local language differences, country-specific requirements, trial-specific language management, centralized language management plus mandatory phrases, use of internal translation people and/or third-party translation companies, secure access to the system by all stakeholders, management of plurals, printing labels ‘on-demand’, multiple page booklets and the associated ‘lead times’. 

However, this breaks down into four fundamental issues that need to be addressed: 

  1. Phase creation, approval and version control 
  2. Language data configuration 
  3. Phrase management using a dictionary concept 
  4. Customizing labels for country/regional specific requirements 

These challenges demonstrate the strategic importance of an effective labeling infrastructure. In an increasingly competitive global marketplace where drug development costs continue to rise, smart investment in innovative labeling technologies can lead to a significant reduction in the cost and operational impact of subject attrition. 

The most effective systems sit at the center of an enterprise and take an integrated, data-driven approach to label management. By focusing on the data, rather than simply the label, organizations can develop a 360° view of their master data assets and enjoy the flexibility to adapt and tailor content to meet country-specific requirements, while also ensuring local regulatory compliance. 

The smartest technologies, like our cloud-based PRISYM 360 software, incorporate language and phrase management tools that allow translations to be pre-agreed and pre-approved, and clinical trial-specific terminology to be specified and validated. 

In summary, although the management of language data can be complex, by using the right principles and approach for configuration, the task can be controlled and well managed by various stakeholders in different locations. 

Contact us for more information about how PRISYM 360 can support your local language management needs. 


Mind Your Language! Requirements for Local Language Labeling in Clinical Trials

mark cusworth - Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

About the author:

Mark Cusworth is the VP Research and Development at PRISYM ID. He has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Clinical Trial companies. During this time, he has seen many changes to the industry including significant tightening of regulations, challenges of globalisation as well as the shift from Subject based to Interactive Response Technology (IRT) trials.

This article was published on September 30th, 2021