SmartSignals Advisory

Language Management

Consistent meanings, consistent results 

Comprehension is key

Localization has always been a critical consideration in the development of new therapies and treatments. The shift towards more foreign trials and the proliferation of virtual trials continues to dramatically increase demand for accurate translations and localizations of all study documentation from enrollment through consent, scale management, and even supply stocking labels.

Poor translations can have drastic impacts on a trial if not executed properly – they can result in invalid or unusable data, rejection of submissions to ethics and regulatory authorities, retraction of copyright permissions, or extended timelines and unexpected costs.

Don’t risk your study by overlooking this critical step. When you partner with Signant Health, we ensure your study is fully localized and linguistically validated from end to end.  

OFTEN COMBINED WITH:

Localize studies & programs

  • Signant Health’s comprehensive suite of clinical research technology solutions including our RTSMeCOAeConsent, Patient Concierge, Rater Training & Qualificationand Site Enablement solutions already include dozens of built-in languages 
  • When your trial requires support for additional languages, we follow an ISPOR-compliant process to translate, back translate, reconcile, harmonize, and validate translations, ensuring native speakers fully comprehend study-related information in the same way as its source documentation intends 
  • Signant Health can supply the experience and resources needed to ensure your study undergoes the full linguistic validation process, so you can be confident all participants share consistency of understanding and that your research produces verifiable, accurate evidence 

Frequently Asked Questions

How does language barrier affect communication in clinical trials?

Language barriers can create unwanted variability and errors in data generated in clinical trials, endangering data quality and clinical outcome solutions.

What is the standard process for eCOA and non-eCOA translations?

For the translation of COAs, Signant follows a Linguistic Validation process, in accordance with ISPOR guidelines. This consists of a concept definition step, two independent forward translations, reconciliation, back-translation, and clinical review. There is an optional cognitive debriefing step, which is recommended for translating patient-reported outcomes when used as primary or secondary endpoints. As for the translation of non-COA materials such as clinical rater training documents, site-facing forms, and the Rater Station user interface, Signant follows a TEP process in which one linguist completes a forward translation of the source and a second linguist reviews the translation.

What is full linguistic validation?

Full linguistic validation is a translation service recommended for ePRO systems which have not been previously validated to ensure harmonization and cultural equivalence across countries and languages. Taking between 10 to 16 weeks to complete, the validation features forward translation, back translation, reconciliation/comparative review, usability testing (if required), cognitive interviewing, screen verification, and certification. A less-rigorous methodology would not be able to provide evidence that the translation accurately reflects the source version or be understood by patients of varying educational and economic backgrounds.

What are the variables factored in when creating the localization planner?

The localization planner includes the turnarounds of all the parties involved (i.e translation vendor/s, Signant’s localization team, instrument owners), project milestones communicated by the sponsor such as IRB or FPFV, and any language/country priorities.

What factors affect localization timelines?

A factor that can affect localization is the study’s complexity. Some translation services or languages require more effort for translation, implementation, and completion. Some instrument owners may request to review and approve all the localized screens, which can cause delayed turnarounds. The ideal scenario is for all source files (i.e paper scales from instrument owner; final Master Screen Report approved by the sponsor) to be in place before localization commences – any delays in finalizing these can also extend timelines.

Want to learn more?

Contact us to learn more about localization solutions or any of our comprehensive suite of clinical trial evidence generation solutions and services.