FAQs
Frequently Asked Questions
General Questions
What is Linguistic Validation?
A rigorous process of translating and culturally adapting patient-reported outcomes, clinical assessments, and medical documentation ensuring conceptual equivalence across languages.
What services do you offer?
– Forward and backward translations
– Cognitive debriefing
– Cultural adaptation
– Harmonization
– Expert review and reconciliation
– Electronic and paper-based validation
Process & Methodology
How do you ensure quality?
We follow ISPOR guidelines with a multi-step process including dual forward translation, reconciliation, back translation, expert review, and cognitive debriefing with target populations.
What is your typical turnaround time?
Standard projects typically require:
– Simple translations: 2-3 business days
– Cognitive Debriefing: 10-15 business days
– Full linguistic validation: 4-6 weeks
– Complex multi-language projects: 8-12 weeks
Do you work with specific therapeutic areas?
We specialize in all major therapeutic areas including oncology, cardiology, neurology, rare diseases, and mental health assessments.
Security & Compliance
How do you protect confidential information?
We maintain strict compliance with HIPAA, GDPR, and industry security standards, including:
– Encrypted data storage
– Secure file transfer systems
– Confidentiality agreements
– Access controls
– Regular security audits
Are your linguists qualified?
All our linguists are:
– Native speakers
– Subject matter experts
– HIPAA certified
– Bound by NDAs
– Regularly evaluated
Project Management
How do you handle urgent requests?
We offer expedited services with dedicated project managers and can adjust resources for urgent timelines with a rush fee.
What languages do you support?
We provide services in over 400 languages with special expertise in rare languages and dialects.
Can you handle large-scale projects?
Yes, we manage multi-country, multi-language projects with dedicated teams and customized workflows.
Commercial Terms
How is pricing determined?
Pricing depends on:
– Project scope
– Language pairs
– Urgency
– Complexity
– Volume
What payment methods do you accept?
We accept bank transfers, major credit cards, and electronic payments through secure platforms.
Technical Support
What file formats do you work with?
We handle all major formats including:
– Word, Excel, PowerPoint
– PDF documents
– eCOA platforms
– XLIFF and other CAT tools
– HTML/XML
Do you provide certificates of translation?
Yes, we provide certificates of translation authenticity upon request for regulatory submissions.