Linguistic Validation Services

Linguistic Validation for Clinical Trials

Improve the accuracy and relevance of translated patient reported outcomes and meet the best standards, through
culturally appropriate translations.

15+ Years Exp

170+ Languages

2,000 Clients

99.75% Satisfied

What is Linguistic Validation for Clinical Trials?

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.

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Need of Linguistic Validation Services

Linguistic validation for healthcare is important, as it ensures a translation that is both accurate and culturally relevant to the local target group; thus, it has a direct impact on clinical research and patient care.  Basic needs include:

Uniformity Ensured

Ensures that the translation depicts the same meaning as the original text to derive correct information while communicating with the patient.

Improves Clinical Outcome Assessment

Enhances data integrity, ensuring reliable multilingual studies and accurate patient outcome assessments.

Enhances Patient Awareness and Safety

Provides patients with clear, understandable translations, improving their safety, awareness, and adherence to treatment protocols.

Supports Multinational Studies

Reduces legal risks and misunderstandings, ensuringconsistency in data collection across diverse linguistic groups in global clinical trials.

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

  • Adverse event source documents
  • Audit documentation
  • Case report forms
  • Clinical outcomes evaluation
  • Investigator brochures
  • Package inserts
  • Clinical study protocols
  • Clinical study reports
  • Data sheets
  • Development safety Update reports
  • Patient diaries
  • Patient Information forms
  • Diagnostic reports
  • Dossiers
  • Drug inserts
  • Informed consent forms
  • Patient instructions
  • Patient recruitment materials
  • Patient-reported outcomes
  • Pharmacological studies
  • Questionnaires
  • Regulatory compliance
  • Study protocols
  • Trial outcome reports

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Why Choose Somya Translators Pvt Ltd?

Enhance your clinical trial process with Somya Translators Pvt Ltd’s Linguistic Validation services. Get in touch with us today to discover how we can help you achieve accurate, reliable, and culturally relevant translations for all your clinical research needs.

Expertise

Our team comprises highly qualified translators and subject matter experts with extensive experience in clinical trials.

Accuracy

Rigorous quality control processes ensure translations are accurate and reliable.

Cultural Relevance

We ensure translations are culturally appropriate and resonate with the target audience

Compliance

Adherence to industry standards and regulatory requirements is paramount.

Comprehensive Service

From forward translation to final QA, our process covers all aspects of linguistic validation.

We’re facilitating our clientele 24*7

Our Dynamic Solutions for You

We’re a professional Language Service solution for all domains in the global industry. Now choose from the capacity of services and let your business have the power of effective language solutions.

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