Linguistic validation

We offer Linguistic Validation for eCOA Solutions, as well as Clinician, Observer, Patient and Performance Outcome Assessments, Cognitive Debriefing for Source Questionnaires, eCOA Integration and Usability Testing, Face Validity Assessment, IVRS Prompt Recording, Licensing / Copyright Services, Linguistic Validation of Clinical Outcomes Assessment, Research Abstracts, Transcription, Translatability Evaluation, Web-Based COA Library and Online Document Management.

Our Linguistic Validation services verify that translation of all items are interpreted in the same way in Korean and have the same content validity. You can be sure that measurement properties of the items will be the same as in English source version of the instrument, that data can be validly pooled across the two international sites and that the process will meet FDA and EMEA guidelines.

Linguistic Validation

OLT provides fully compliant Linguistic Validation and Cultural Adaptation services, including Cognitive Debriefing. We ensure that your eCOA is both culturally appropriate and conceptually equivalent in both Source English and the target language of Korean.

This is crucial to ensure that content validity is not affected by translation, and that data can be pooled across different sites.

Benefits of Linguistic Validation

Our Linguistic Validation services ensure that all translated items are interpreted consistently in Korean and have the same content validity as the original English version. You can rest assured that the measurement properties of the items will be the same as in the English source version, allowing for valid data pooling across international sites, and compliance with FDA and EMEA guidelines.

Linguistic Validation and Cognitive Debriefing

OLT follows the rigorous Linguistic Validation and Cognitive Debriefing process recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Our team includes project managers, translators, local investigators (interviewees), clinicians, psychologists, linguists, and other necessary professionals.

Linguistic Validation Process

Our localization services cover a wide range of medical fields, including:

  • Cardiology
  • Oncology
  • Central Nervous System (CNS)
  • Pain/Inflammation
  • Dermatology
  • Psychology
  • Endocrinology
  • Psychiatry (including depression, schizophrenia, anxiety)
  • Gastroenterology
  • Pulmonology
  • Gynecology
  • Rheumatology
  • Hematology
  • Urology
  • Nephrology
  • Women’s Health
  • Neurology
  • Ophthalmology