Clinical Outcome Assessment Translation and Migration Services

Reduce administrative burden when securing permissions and licenses. Enhance consistency, visibility, and compliance with copyright and IP requirements. Services include:

• Assistance developing budget assumptions for licensing and linguistic/subject matter expert work for COA translation and cultural adaptation.

• Facilitation and coordination of licensing for paper-based and electronic COAs

• Collaboration with instrument developers, copyright holders, publishers, and key opinion leaders

• COA library management

• Translatability Assessment to evaluate an instrument’s suitability for multilingual use, thus ensuring conceptual equivalence and facilitating reliable cross-linguistic data comparison.

• Translation and Linguistic Validation for All COA Types, including:

  • Patient-Reported Outcomes (PROs)
  • Clinician-Reported Outcomes (ClinROs)
  • Observer-Reported Outcomes (ObsROs)
  • Performance Outcomes (PerfOs)

• Cultural and Linguistic Adaptation to address cultural nuances and language-specific challenges across diverse populations.

• Cognitive Debriefing & Clinician’s Review to validate participant understanding and clinical relevance of translated content, as appropriate.

• Harmonization Across Languages to ensure consistency and fidelity of meaning in all language versions of an instrument.

• Support for Accompanying COA Materials, such as administration manuals, scoring guides, and eCOA screen texts/booklets.

• Expert Handling of Diverse Instruments, including diagnostic, efficacy, safety, and other types used in clinical studies.

• Flexible Solutions for All Input Types, ranging from simple patient diaries to complex assessment batteries, across all therapeutic areas and indications.

Document and device translation and validation services help to streamline multilingual electronic reporting. Services include:

• eCOA migration/ eCOA implementation

  • Paper-to-electronic text migration

• Measurement equivalence testing

• Translation and localization of supplemental materials (device labels, patient quick reference guides, site manuals, posters)

• Screen report verification and harmonization

  • Usability Testing

• IVRS/IWRS/ePRO linguistic validation, including voice recording

• Development of eCOA Booklets for specific measures in agreement and compliance to the relevant copyright holders

Lionbridge created an optimized, end-to-end workflow for an eCOA provider, maximizing efficiency and significantly reducing administrative burden.