Improve the accuracy and relevance of translated patient reported outcomes and meet the best standards, through
culturally appropriate translations.
At Somya Translators Pvt. Ltd, we understand the important role of precise translations in clinical trials. Our Linguistic Validation (LV) solutions are carefully constructed to ensure the reliability and validity of patient-reported outcomes (PROs). This thorough process ensures that translations are accurate, culturally appropriate, and comply with industry standards, thereby managing and protecting the integrity of clinical trial data.
Boost Accessibility and Performance with Our Expertise!
Our Comprehensive Workflow
Step 1: Forward Translation A and B
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
Step 2: Reconciliation
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.
Step 3: Editing
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.
Step 4: Back 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.
Step 5: Equivalency
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.
Step 6: Forward Translation Update
The forward translation team resolves all comments and discrepancies identified during the equivalency review, making any necessary adjustments to the forward translation.
Step 7: Back Translation Update
The updated forward translation is sent to the back translation team, who update the back translation accordingly.
Step 8: Clinician Review/SME Review
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.
Step 9: Cognitive Debriefing
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
Step 10: Forward Translation Update 02
Reports from the clinician review or cognitive debriefing are addressed by the forward translation team, applying necessary updates.
Step 11: Back Translation Update 02
The updated forward translation is sent to the back translation team, who update the back translation accordingly.
Step 12: Final QA
Final QA ensures all issues from the clinician and/or cognitive debriefing reports are addressed, creating the final version of the translation.
Suitable Domains and Document Types
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
Types of Documents we Translate for Clinical Trials Translation
Boost Accessibility and Performance with Our Expertise!