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

By Mark Cusworth

The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component of this is the need to comply with variable local language labeling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.

Local language labeling is concerned with how to manage phrases in different languages and to drill down to a highly local language level to ensure the instructions and information provided are understood precisely. For example, in South America several versions of Spanish may be required. The need for a local person to understand these subtleties is important and the use of technology to assist in this process is essential, yet difficult to achieve.

‘The complexities of local language labeling’ can include, but are not limited to:
• Management and control independent of the language
• 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’

Regardless of the differences in the approach to the management of phrases and local language labeling there are a number of key aspects 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 of local language labeling, and of maximizing the real estate of complex label designs, once again shines a light on 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 will sit at the centre of an enterprise and take an integrated, data-driven approach to label lifecycle 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, also ensuring local regulatory compliance. The smartest technologies will include 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.

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Read our blog: Clinical trials: when the label became more significant than the drug itself…

About the author:

mark cusworthMark 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.