Linguistic Validation
When you work in the life sciences field, no matter your organization’s speciality, you understand the need for translated content to be clear, unbiased, and error-free. A mistranslation or inconsistency can jeopardize your reputation, your submission, or the safety of patients and trial participants. Avantpage Life Sciences is here to ensure your product makes it to market on time and without these issues. Every project we translate is performed by highly skilled linguists and goes through a rigorous, multi-step quality assurance process. For those times that you need additional reassurance, be it as a regulatory requirement or for peace of mind, our linguistic validation solution is here to help. Connect with us for seamless language solutions.
Importance in Clinical Trials
Linguistic validation in clinical outcome assessments (COAs) and patient-reported outcomes (PROs) ensures that translations are accurate and culturally relevant, which is crucial for maintaining the integrity of clinical trial data. This process guarantees that participants from diverse linguistic backgrounds fully understand the materials, leading to reliable data collection. Ultimately, it enhances the quality of research outcomes and improves patient care by ensuring that all participants can provide meaningful and accurate responses.
What is Linguistic Validation?
At Avantpage Life Sciences, we offer linguistic validation as an expanded quality process that you can tailor to your needs. Below are the available steps, which you can select in their entirety or as a smaller, customised package.
TRANSLATION
The conversion of your text from source to target language. This step already involves a multi-step quality assurance process, with translation, editing, and proofreading performed by three independent, qualified medical linguists. Our linguists are supported by technologies that ensure consistent terminology across documents and integrate client glossaries as appropriate.
SECOND TRANSLATION
This optional step involves a second team translating the same text into the same language pair. The two target documents are then compared and combined to make one complete, merged version in the target language.
BACK TRANSLATION
The target text is then translated back into the source language by a separate team of specialist linguists that has no knowledge of the original source document. Uninfluenced by the original document, they give a true translation that will help highlight any misunderstandings or changes in tone during the initial translation step.
COMPARISON AND CORRECTION
The source-language texts are now compared side by side to ascertain whether any meaning was lost during the translation process. If necessary, corrections are made to the initial translation to reconcile any differences that were identified. If your project involves multiple languages, all back-translated files are compared at the same time to be sure that translation quality is consistent. This eliminates any bias in one or more of your languages.
COMMUNITY REVIEW
During this step, a selection of representative patients/consumers is assembled per language pair to review the translated materials. They are asked a series of questions that gauge clarity, accuracy, cultural appropriateness, and readability of the target texts. The participants are also given an opportunity to suggest improvements or make other comments for consideration. These interviews are conducted by a professional Avantpage Life Sciences team and feedback is shared with you before any implementation of changes.
CREATION OF FINAL COPY
The results of the above steps, whether you selected one or all of them, are brought together to enable our team to provide a final translated version for your approval.
When Do You Need This?
Linguistic validation is a supplementary solution that provides an extra layer of quality assurance and can mitigate risk in a high stakes project. It is particularly useful for clinical trial translations, where the way in which a participant interprets a translated questionnaire can have far reaching effects on your trial data. If you are requesting translation of Clinician-Reported Outcomes, Patient-Reported Outcomes Assessments, Clinical Outcomes Assessments or other trial-related reports, consider adding linguistic validation to your project.
Depending on your product or speciality, linguistic validation and back translation may be a requirement of the regulatory authorities. If this is the case, then even this longer process may ultimately save you time if it prevents the rejection of your project submission.
The optional steps of this validation process allow you a deeper look into the quality of the translation you are receiving, and you are free to request them at any time. Avantpage Life Sciences is committed to providing the highest quality on any project, regardless of whether these additional steps are added to the process. Our linguists are highly qualified in the subject matter required for each project and are supported by state-of-the-art technologies that form an integral part of our standard quality assurance.
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