Pharmaceutical

Pharmaceutical_InsetImage_MainIn today’s highly regulated and increasingly global regulatory compliance environment, pharmaceutical companies face an ever-present challenge: Clinical document translation. Translation that requires absolute precision, with rigid adherence to deadlines, costs, cultural sensitivity – and quality you can trust. Lionbridge Life Sciences provides industry-leading expertise, enabling you to manage regulatory risk, ensure patient safety and gain global market share in one seamless and assured experience.

Make high-quality translation a high priority

The complexity of a clinical trial grows exponentially when trial documents need to be translated into the patient pool’s native languages. The variables to ensure certified, on-time translations increase with each geography. And as studies ramp up and down, scaling issues come into play.

Now more than ever, language translation is a critical element to the success of global clinical trials and global regulatory submissions. Yet it is typically not a core competency of a pharmaceutical company, CRO or protocol author. More often than not, language translation is the smallest line item in any global clinical trial or regulatory effort. It’s time to reconsider your priority list.

Lionbridge Life Sciences works diligently with pharmaceutical companies to support trial success by:

  • Planning for language early
    We provide counsel on what works culturally even if the documents and the trial sites have not yet been selected.
  • Marshalling our in-country teams
    We directly oversee the entire translation process to protect our customers’ IP, ensure consistent, harmonized translation methodologies and reduce our customers’ trial risk profile.
  • Following industry standards
    We adhere to ISPOR, ISOQoL and robust SOPs around all parts of the translation process – and establish a secure repository for all documents along with a well-established version control methodology.
  • Sharing proven content
    We offer a cloud-based Translation Memory service to provide a safe, convenient way to share and re-use translated electronic content from prior studies.
  • Applying best practices in data collection
    We have built a proven set of best practices thanks to our experience in collecting clinical trial data from emerging markets like India, China and Eastern Europe – and we’ll apply them so your trial complies with worldwide regulations, plus guidance for data quality and integrity traceability.

It’s critical that clinical trial documents are culturally correct, certified and, for Quality of Life instruments, validated. Improper translations can have a profound effect on the success of a clinical trial. Partner with Lionbridge Life Sciences and make sure your trial translates to the best outcomes.

Global Regulatory Solutions

Our team can help you meet all multilingual filing requirements, including:
Pre-Approval Submissions:

  • CTA/NDA Applications and Product Information
  • Dossiers
  • PIL User Testing
  • Pharmacovigilance and Safety Reporting

Post-Approval Documents:

  • Supplements, Amendments and Applications
  • Regulatory Style Guide/Checklist Creation and Maintenance