Linguistic Validation for Clinical Trials

The forward translation process involves translating the source content into the target language by two or more qualified translators. This step ensures that the text retains the original meaning and context while reading naturally in the target language. Key document types include:

• Clinical protocols
• Informed consent forms
• Patient diaries
• Adverse event reports

An independent linguist compares the two forward translations with the original text. This step is essential for ensuring the highest quality and accuracy, assessing the conversions for precision, cultural appropriateness, and consistency with the clinical terminology of pharmaceutical and medical device companies.

A linguist refines the reconciled version to ensure that it accurately reflects the source text and is free from errors. This detailed review offers a natural and precise translation.

Back translation includes converting the target language content back into the source language by an independent translator who was not involved in the initial translation. This step helps identify any deviations or loss of meaning that may have occurred during the process of translation.

Equivalency involves a thorough comparison of the back translation to the source document by an independent linguist. This step identifies discrepancies in meaning and ensures that the translation is equivalent in intent to the original source.

The forward translation team resolves all comments and discrepancies identified during the equivalency review, making any necessary adjustments to the forward translation.

The updated forward translation is sent to the back translation team, who update the back translation accordingly.

In Our Clinician Review process the translated medical content is reviewed by SME’s and healthcare specialists to ensure the accuracy, clarity and relevance of the content.

This step adds a layer of quality assurance for the documents like patient information leaflets, consent forms, medical reports, or clinical trial materials.

Cognitive debriefing collects feedback from native speakers within the target demographic to evaluate comprehension and cultural relevance. By combining these steps, we ensure that patient-reported outcomes (PROs) are accurately converted and easily understood, preserving the integrity and relevance of the clinical trial data. These processes ensure that translations meet the industry standards and effectively convey the intended meaning to the target audience.22

Reports from the clinician review or cognitive debriefing are addressed by the forward translation team, applying necessary updates.

The updated forward translation is sent to the back translation team, who update the back translation accordingly.

Final QA ensures all issues from the clinician and/or cognitive debriefing reports are addressed, creating the final version of the translation.

Our Linguistic Validation services are ideal for a variety of domains and document types, that include:-

• Clinical trials
• Pharmaceutical documentation
• Medical device localization
• Healthcare surveys
• Regulatory submissions