OLT offers fully compliant Linguistic Validation and Cultural Adaptation services, including Cognitive Debriefing.
We ensure your eCOA is both culturally appropriate and conceptually equivalent in the pair of the Source English and target Korean.
This can be critical to ensure that content validity is not affected by translation, and that data across sites can be pooled.
Linguistic Validation Benefits
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 and Cognitive Debriefing
OLT employs a rigorous Linguistic Validation and Cognitive Debriefing process that follows the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommended methodology.
Our team for the project consists of project managers, translators, local investigators (interviewees), clinicians, psychologists, linguists and other professionals as necessary.
Localization services we cover include the following:
- Central Nervous System (CNS)
- Psychiatry (including depression, schizophrenia, anxiety)
- Women’s Health
Linguistic Validation for eCOA Solutions
- 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 Outcome Assessments
- Research Abstracts
- Translatability Evaluation
- Web-Based COA Library and Online Document Management