Email Us

Comprehensive Linguistic Validation for Enhanced Clinical Accuracy

CONTACT US NOW

Linguistic validation is a critical process in the field of medical research and pharmaceuticals, particularly when dealing with multilingual clinical trials and global healthcare services. The main goal of linguistic validation is to ensure that translated documents are not only linguistically accurate but also culturally relevant and understandable to participants in clinical trials or users of medical products. This ensures that the intended meaning, nuances, and clinical information are maintained across languages,


At Willingjet, we specialize in delivering top-tier linguistic validation services tailored to support pharmaceutical companies, CROs, and healthcare organizations in achieving precise clinical outcomes and regulatory compliance. Our approach is designed to enhance the validity of translated clinical assessments and ensure that all instruments reflect the intended medical and cultural nuances.


Typical Process

The typical process of linguistic validation includes the following steps.

Translation and Review
Translation and Review

Professional translators and reviewers translate the original documents into the target language(s).

Double Translation
Double Translation

Second forward translation to minimize the misunderstand on source content or misalignment.

Back Translation
Back Translation

A separate translator translates the translated documents back into the original language.

Harmonization
Harmonization

Comparison of the back-translated documents with the original documents to identify and resolve any discrepancies.

Cognitive Debriefing
Cognitive Debriefing

Testing of the translated documents with native speakers of the target language(s) through cognitive debriefing interviews to ensure comprehension and cultural appropriateness.

Cross-cultural adaptation
Cross-cultural adaptation

Cross-cultural adaptation to ensure that the translated material is culturally appropriate and relevant for the target audience.

PRO Validation
PRO Validation

Validation of patient-reported outcomes (PRO) measures to ensure that they accurately measure what they intend to measure and are understandable to the target population.

Finalization
Finalization

Preparation of final versions of the translated documents based on feedback from cognitive debriefing interviews and validation report.

Deep Dive into Cognitive Debriefing

When it comes to understanding the nuances of cognitive processes, our approach transcends theoretical frameworks to embrace real-world scenarios. The Cognitive Debriefing Process is where theory meets reality, as instruments undergo testing with actual participants to assess comprehension and effectiveness.

01
Recruitment

Under the diligent oversight of our Recruitment team at Resourcing, we meticulously identify and enlist the ideal cohort of patients. Tailoring our selection criteria to match client specifications and research parameters, we aim for a minimum of 5 participants. Factors such as gender, age, occupation, education, and health status are carefully considered to ensure a diverse and representative sample.

02
Cognitive Interviews

Enter the realm of cognitive interviews, where skilled clinical interviewers engage participants in face-to-face or virtual interactions. Leveraging advanced software tools like Valitracks, we capture and document participant insights in real-time. This dynamic setup allows stakeholders such as investigators, clients, and regulatory bodies to actively monitor progress, provide feedback, and expedite the validation process.

03
Summary Report

Upon the completion of interviews, the findings are distilled into a comprehensive summary report. Results are meticulously translated into the source language, typically English, for in-depth discussion with key stakeholders. Should further clarification be required, additional rounds of questioning may ensue, leading to iterative refinements. Ultimately, recommendations are formulated and presented to the project manager, shaping the final iteration of the document.

Documents that Need Linguistic Validation

Linguistic validation is crucial in the medical and pharmaceutical fields to ensure that documents used in clinical trials and healthcare settings are accurately translated and culturally appropriate. Here are the typical documents that require linguistic validation

Clinical Outcome Assessments (COA-eCOAs)
Documents that Need Linguistic Validation
Patient-Reported Outcomes (PROs)

These are self-reported assessments where patients describe their symptoms, overall health status, and the impact of the disease and treatment on their daily lives, without interpretation by a healthcare provider. PROs are vital for understanding the effectiveness of medical interventions from the patient's perspective.

Clinician-Reported Outcomes (ClinROs)

These assessments are reported by trained healthcare providers based on their observation and clinical judgment. ClinROs evaluate aspects of a patient's health status that are observable and measurable, such as motor function and physical signs of a disease.

Observer-Reported Outcomes (ObsROs)

Reports by someone other than the patient or healthcare provider, typically a family member or caregiver, observing the patient's health condition. ObsROs are used when the patient is unable to report for themselves, such as in pediatric or cognitive impairment studies.

Performance Outcomes (PerfOs)

These involve tasks performed by a patient that are scored by an assessor. PerfOs can assess physical capabilities, mental abilities, or other functions to evaluate treatment impacts or disease progression.

Why Leading Brands Trust Willingjet

Experienced Team

Our team comprises over 3,000 medical linguists and subject matter experts globally, ensuring that your project benefits from profound professional expertise and localized knowledge.

Innovative Technology

With our WJLingua Suite, we are setting new standards in the efficiency and comprehensiveness of linguistic validations.

Client-Centric Approach

We tailor our services to meet the specific needs of each client, ensuring flexibility and responsiveness throughout the validation process.

Proven Track Record

We successfully conduct over 200 linguistic validation projects annually, demonstrating our capability and reliability in the field.

ISO 9001
ISO 9001
ISO 17100
ISO 17100
ISO 13485
ISO 13485
ISO 27001
ISO 27001
ISO 14001
ISO 14001
ISO 28000
ISO 28000
Get in Touch
Ready to learn more about our Linguistic Validation services? Contact us today!
CONTACT US
Featured Services
Medical Translation
Your trusted partner in medical document translation for the past 20+ years.
Medical Writing
Crafting clear, compliant, and compelling medical documents to accelerate your clinical and regulatory success.
IP Services
Protecting your ideas, securing your future globally.
Interpretation
Contact us to get a quote in 48 hours with equipment solutions and talent options that best meet your need.
Related Posts
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence
In the dynamic realm of translation, the advent of artificial intelligence has not only revolutionized the tools and techniques at translators' disposal but has also transformed the very nature of...
Navigating the Changing Landscape: Translator Growth in the Era of Artificial Intelligence 12 07 2024
The Impact of AI Technology on Translation Costs
The Impact of AI Technology on Translation Costs
In the rapidly evolving landscape of translation technologies, Artificial Intelligence (AI) has introduced significant shifts in how translation services are rendered and priced. As AI continues to ad...
The Impact of AI Technology on Translation Costs 12 07 2024
Unlocking Efficiency in Life Sciences Translation Management with TMS
Unlocking Efficiency in Life Sciences Translation Management with TMS
Translation Management System (TMS) plays a pivotal role in streamlining and optimizing translation processes, and its significance in the field of life sciences cannot be overstated. In this article,...
Unlocking Efficiency in Life Sciences Translation Management with TMS 11 07 2024
Enhancing Medical Translation Efficiency with Translation Memory
Enhancing Medical Translation Efficiency with Translation Memory
IntroductionIn the dynamic field of medical translation, the role of Translation Memory (TM) has become increasingly pivotal, revolutionizing the way pharmaceutical content is translated. Understandin...
Enhancing Medical Translation Efficiency with Translation Memory 10 07 2024