Cognitive Debriefing Services
ISPOR-compliant patient interviews to validate translated clinical outcome assessments. 1,000+ trained moderators across 150+ languages.
What is Cognitive Debriefing?
Cognitive debriefing is a critical step in linguistic validation where native-speaking patients review translated clinical outcome assessments to ensure clarity, cultural relevance, and conceptual equivalence with the original instrument.
The US FDA and EMA require cognitive debriefing to demonstrate content validity for translated instruments used in clinical trials and regulatory submissions.
Our Cognitive Debriefing Process
A systematic approach aligned with ISPOR guidelines for maximum regulatory acceptance.
Protocol Development
Customized interview guides aligned with ISPOR best practices and your specific instrument.
Participant Recruitment
We recruit 5-8 qualified participants per language matching your target patient population.
Interview Conduct
Trained native-speaking moderators conduct structured interviews via video, phone, or in-person.
Analysis & Reporting
Comprehensive analysis of comprehension issues with actionable recommendations.
Instruments We Validate
Patient-Reported Outcomes
Self-reported health status, symptoms, quality of life
Clinician-Reported Outcomes
Healthcare provider assessments and evaluations
Observer-Reported Outcomes
Caregiver or family member observations
Performance Outcomes
Standardized tests and functional assessments
Specialized Patient Populations
We have extensive experience recruiting and interviewing specialized populations that require adapted cognitive debriefing approaches.
Pediatric
Ages 5-7, 8-12, 13-17
Geriatric
Extended sessions, visual aids
Rare Disease
Flexible recruitment
Cognitive Impairment
Simplified probing
Caregiver/Observer
Proxy respondents
Frequently Asked Questions
How many cognitive debriefing participants are needed per language?
ISPOR guidelines recommend 5-8 participants per language for cognitive debriefing interviews to ensure adequate assessment of patient comprehension and cultural appropriateness.
What interview formats are available for cognitive debriefing?
We offer video call, telephone, and in-person cognitive debriefing interviews depending on your study requirements, participant population, and geographic locations.
How long does cognitive debriefing take?
Cognitive debriefing typically takes 2-4 weeks depending on the number of languages, participant recruitment complexity, and interview scheduling requirements.
Can you recruit specialized patient populations?
Yes, we have extensive experience recruiting pediatric patients (ages 5-17), geriatric populations, rare disease patients, and individuals with cognitive impairment.
Is cognitive debriefing required by FDA and EMA?
Yes, both FDA and EMA require cognitive debriefing as part of linguistic validation to demonstrate content validity for translated clinical outcome assessments.
Request a Cognitive Debriefing Quote
Get a customized quote within 24 hours. Our team will assess your requirements and provide a detailed proposal.
Request Cognitive Debriefing Quote
Fill in your details below and we'll send you a quote.
Trusted by leading pharmaceutical and biotech companies
Ready to Validate Your Translations?
Partner with Cethos for ISPOR-compliant cognitive debriefing that meets FDA and EMA requirements.
No commitment required - Response within 24 hours - 150+ languages