Lionbridge Life Sciences Introduces New Features of its Clinical Labeling Solution to Accelerate Global Clinical Trials

End-to-end Clinical Labeling Translation Solution Helps Organizations Reduce Risk & Improve Efficiency while Remaining Fully Compliant with Regulatory Guidance

WALTHAM, Mass. – June 19, 2017 &mdash Lionbridge Technologies, Inc., the world’s most trusted translation and digital communications company, today announced enhancements to its Clinical Labeling translation solution, an end-to-end offering that helps global life sciences organizations easily translate labeling content for clinical studies while remaining compliant with global regulatory requirements.

The features of the Clinical Labeling solution include an enhanced, fully customizable workflow for label text creation, translation and validation across more than 100 markets and languages. In addition, Lionbridge Life Sciences has integrated its labeling translation solution with leading suppliers of clinical labeling design, production and management services, allowing easy integration of translation processes within clients’ existing labeling management platforms.

“As a global leader in clinical supply chain solutions, we needed a partner that could deliver accurate clinical labels while integrating regulatory compliance, packaging capabilities and country validation,” said Jamie Pieron, Manager of Client Services Operations, Clintrak Clinical Labeling Services. “By leveraging Lionbridge’s expansive global regulatory network and expertise, we can continue to provide our clients with a clinical labeling model that improves efficiency and reduces overall risk.”

Lionbridge’s proven technology platform, combined with Lionbridge’s expansive network of qualified translators and regulatory experts enables pharmaceutical and biotechnology organizations to reduce the overall label cycle times and simplify global label creation. Key benefits of the enhanced Lionbridge Clinical Labeling solution include:

  • Greater Flexibility – From a single label in a single market to multiple labels across 60 markets simultaneously, organizations have increased flexibility to tailor the clinical labeling process to their specific needs.
  • Increased Efficiency – Customizable workflow generates high quality, translated content that meets target audiences, while reducing turnaround times and increasing overall operational efficiencies.
  • Improved consistency and error reduction – By providing an end-to-end solution, organizations can decrease the added complexities that often come with working with multiple vendors, avoiding translation errors and increasing consistency and speed without sacrificing quality.
  • Regulatory Conformity – Ensure 100 percent compliance by leveraging expertise with local Health Authorities’ labeling guidelines (FDA, EMA, PDMA and more), along with Lionbridge’s certifications in ISO 9001, ISO 13485 (including risk management) and EN 17000.

Every year, the number of registered global clinical trials grows significantly, with more than 245,000 studies currently in operation across 200 countries. Managing drug and medicine labeling for multi-site, international studies is a complicated process that requires specific skills and considerations, and becomes an even more difficult task when factoring in the constant changes of industry regulations. Lionbridge’s Clinical Labeling solution follows continuous improvement measures that are up-to-date with industry best practices and regulations, while maintaining linguistic consistencies across all markets and languages.

“As clinical study sites increasingly expand to more and more global regions, it’s imperative that organizations are fully aware of shifting regulatory requirements, or they risk errors and inconsistencies that can result in serious implications for patient safety and regulatory approval,” said Mark Aiello, General Manager Lionbridge Life Sciences. “Our Clinical Labeling solution provides a simplified and customizable workflow that allows organizations to efficiently translate content and streamline their clinical labeling processes.”

Lionbridge’s Clinical Labeling solution addresses current business challenges by utilizing a wide network of experienced experts that cover all relevant regions and health authorities for study sites. As a result, organizations can ensure that clinical labels depict the correct dosage, administration and storage instructions while remaining compliant with local and regional regulatory rules.

To learn more, visit http://lifesciences.lionbridge.com/what-we-do/services-function/regulatory/.

About Lionbridge

Lionbridge enables more than 800 world-leading brands to increase international market share, speed adoption of products and effectively engage their customers in local markets worldwide. Using our innovative cloud technology platforms and our global crowd of more than 100,000 qualified professionals, we provide detail-critical business processes, including translation, online marketing, global content management and application testing solutions that ensure global brand consistency, local relevancy and technical usability across all touch points of the customer lifecycle. Based in Waltham, Mass., Lionbridge maintains solution centers in 27 countries. To learn more, visit www.lionbridge.com.

Media Contact:

Aimee Jen
Text100
NALionbridge@text100.com
+1-617-399-4924