In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
Welcome to Shukra Solutions
20+
years of expertise in translation & linguistic validation
At Shukra Solutions, we help our clients put patients' voices at the heart of COA development in every language.
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
Expert Linguistic Validation Solutions, Tailored for India.
Partner with Shukra to ensure that your COAs are accurate in every language.
Cognitive Debriefing
Interviews with diverse groups of patients from your selected target therapeutic area.
Paper COA Proofreading
Proofreading by local linguistic validation experts who are native speakers of the target language.
eCOA Screen Reviews
Electronic Screenshot Reviews by native speakers, ensuring that content and layout is accurate for electronic modalities.
Clinician Reviews
Reviews by domain-skilled clinicians who are native speakers of the target language, ensuring that the translation will be fully appropriate for the patient population.
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
The Linguistic Validation Process
To ensure a high level of precision with COA translations, the FDA recommends a rigorous linguistic validation process that follows ISPOR Principles of Good Practices for the Translation and Cultural Adaptation for Patient-Reported Outcomes (PRO) Measures.
01
Concept Elaboration
A concept elaboration guide explains key concepts in the source questionnaire and clarifies wording that may have multiple interpretations or might be difficult to convey in other languages.
02
Harmonization
Two independent translators prepare separate translated versions of the source text, then collaborate to choose the best version of the two translations for each segment. This is the harmonized translation.
03
Back Translation & Quality Reviews
A third linguist translates the harmonized version back to English. The back-translation then undergoes multiple quality reviews to resolve conceptual differences between the original English and the harmonized translation.
04
Developer / Clinician / Site Reviews
If applicable, the translation undergoes reviews by the questionnaire developer, clinicians and/or local site staff.
05
Cognitive Debriefing
In-person or virtual interviews with a sample group of patients from the target therapeutic area. During 1:1 interviews, patients review the translation and provide feedback.
06
Debriefing Analysis & Finalization
Patient feedback is analyzed and solutions are implemented to any issues that were encountered. After this, the questionnaire undergoes final quality checks before being certified as linguistically validated.
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
Connect with Shukra Solutions
Reach out to us to discuss how our services can benefit your business. Our team is ready to assist you with any inquiries.
Global Office Hours
Monday-Friday
8:00 am to 6:00 pm
Email us
info@shukrasolutions.com
Call Us
+1-847-704-2873
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
In the right area, tell Kimmy what kind of section you want to add, like "I'd like to add a product introduction here."
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