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What Is Back Translation?

Back translation is a quality assurance method used in clinical and regulatory translation to verify linguistic equivalence. It involves translating previously translated content back into the original source language by an independent linguist who has no prior exposure to the original text. The resulting back-translated version is then compared with the original to identify discrepancies in meaning, tone, or terminology.

This process is particularly important in clinical research, where patient-facing materials, informed consent forms, and clinical outcome assessments must retain their original intent across languages. Unlike forward translation, which converts content from the source language to the target language, back translation serves as a validation step to ensure that the translated version accurately reflects the source content.

Back translation is commonly used during linguistic validation of Patient-Reported Outcomes (PROs), eCOAs, and other clinical instruments. Regulatory authorities such as the FDA and EMA, as well as IRBs and ethics committees, may request documented back translations to confirm that translated content is conceptually equivalent and culturally appropriate.

As a leading provider of back translation services, Sesen supports sponsors, CROs, and regulatory teams in reducing translation risk and ensuring global compliance.

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When and Why Back Translation Is Required

Back translation is a critical step in clinical trial translation workflows when accuracy, consistency, and regulatory compliance are non-negotiable. It is often required as part of linguistic validation processes to confirm that translated content maintains the original intent, especially when used in high-risk or patient-facing contexts.

This method is widely applied in the translation of Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), and electronic COAs (eCOAs), where precise phrasing and conceptual equivalence directly impact data quality and patient safety. Regulatory bodies such as the FDA and EMA, as well as institutional review boards (IRBs) and ethics committees, frequently request back translations to verify the accuracy of translated content submitted for review.

Back translation is also recommended for informed consent forms (ICFs), patient diaries, recruitment materials, and other trial documents that involve direct patient communication. In these cases, a back translation helps mitigate the risk of misinterpretation that could compromise informed consent or protocol compliance.

Sponsors, CROs, and clinical research teams may request back translation as part of a standard validation package or to address specific regulatory expectations across global trial sites. It plays an essential role in meeting GCP-aligned documentation standards and supporting approval processes in multilingual study settings.

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Sesen’s Back Translation Process

Sesen follows a structured, ISO-certified back translation process designed to ensure linguistic accuracy, conceptual equivalence, and full regulatory transparency. Each step is aligned with industry standards for linguistic validation and supports the integrity of multilingual clinical and regulatory content.

The process begins with two independent forward translations (commonly referred to as Translation A and Translation B), both performed by professional native-language linguists with subject-matter expertise in clinical and regulatory domains. These versions are then reconciled into a single, unified translation through a collaborative review process that incorporates the strengths of each version.

A separate linguist, with no access to the original source, independently translates the reconciled forward version back into the source language. This step helps reveal any deviations in meaning or phrasing.

Sesen’s in-house reviewers and project linguists conduct a side-by-side comparison of the original source text and the back-translated version to identify conceptual discrepancies, inconsistencies, or mistranslations.

Any issues found are reviewed in collaboration with the original translators to harmonize terminology, correct misunderstandings, and confirm alignment with the source intent.

A complete audit trail of the back translation and reconciliation process is documented, including reviewer notes and tracked changes. This package is often submitted to sponsors, IRBs, or regulatory bodies as part of a formal validation dossier.

Sesen integrates the back translation step within a broader linguistic validation framework that may also include cognitive debriefing, translation reconciliation, and proofreading to ensure completeness and compliance across languages.

This rigorous process ensures translated materials are both scientifically accurate and culturally appropriate, minimizing risk and enhancing patient safety in global clinical trials.

Quality Assurance and Compliance

Sesen delivers back translation services that meet the highest standards of quality and compliance required for global clinical trials and regulatory submissions. Our workflows are designed to align with Good Clinical Practice (GCP) and ensure full transparency throughout the linguistic validation process.

All translation activities are governed by ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications, which establish rigorous requirements for quality management, translator qualifications, and process control specific to medical and life sciences content.

We work exclusively with domain-specialized linguists who possess clinical research and regulatory expertise to ensure that translated content maintains its scientific and legal integrity across languages. Each project undergoes multi-step linguistic review, including reconciliation, back translation, and final QA validation, with clear documentation of all changes.

Confidentiality and data security are central to our operations. Sesen implements strict access controls, encrypted file transfers, and secure data storage to protect sensitive trial materials and patient information.

Our teams provide comprehensive audit trails and compliance documentation that support sponsor and CRO submissions to the FDA, EMA, IRBs, and other regulatory bodies. We also collaborate directly with regulatory affairs teams, ethics committees, and clinical operations stakeholders to address review feedback and validation requirements.

Sesen’s commitment to quality and compliance gives clients confidence in the linguistic accuracy and regulatory readiness of their global trial documents.

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Back Translation Use Cases Across Life Sciences

Back translation plays a critical role across a wide range of life sciences applications, where linguistic precision directly affects regulatory approval, patient safety, and data integrity. Sesen supports sponsors, CROs, and medical manufacturers by applying back translation methodologies to ensure that translated content is conceptually accurate, culturally appropriate, and ready for global submission.

Back translation is widely used during the linguistic validation of Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), and eCOAs to confirm that key measurement instruments retain their original meaning across target languages. It is also applied to patient recruitment materials, diaries, and site communications to support protocol adherence and participant engagement.

For pharmaceutical sponsors, back translation is essential when translating Informed Consent Forms (ICFs), product information, and medication guides. It ensures that patients and healthcare providers receive consistent and clear messaging that aligns with the source regulatory content.

Medical device documentation such as Instructions for Use (IFUs), software manuals, and eLabeling must be linguistically accurate and user-friendly. Back translation helps validate critical safety and usage information, reducing the risk of misunderstanding in high-stakes environments.

In global and regional health studies, back translation supports the accurate localization of survey instruments, public health questionnaires, and educational outreach materials. This process helps preserve the intent of health interventions while ensuring cultural and linguistic appropriateness for diverse populations.

Sesen’s flexible and compliant back translation services are designed to meet the needs of regulated content across the life sciences value chain, from clinical development to market access and public health.

Related Linguistic Validation Services

Back translation is one component of a broader linguistic validation framework essential for producing accurate, patient-centered, and regulatory-compliant translations in clinical trials. Sesen offers a full suite of complementary services designed to support the development, validation, and localization of clinical and patient-facing materials.

  • Linguistic Validation Services

    End-to-end validation of translated clinical instruments through dual forward translation, reconciliation, back translation, cognitive debriefing, and documentation support.

  • Translation Reconciliation Services

    Expert comparison and harmonization of multiple forward translations to produce a unified, high-quality target-language version prior to back translation.

  • Cognitive Debriefing Services

    Patient interviews conducted in the target language to assess the clarity, comprehension, and cultural relevance of translated instruments.

  • ePRO & eCOA Translation Services

    Specialized translation and validation of electronic patient-reported outcomes and clinical outcome assessments for digital deployment.

  • Informed Consent Form Translation

    Accurate and compliant translation of ICFs to support ethical review and ensure patient understanding in multilingual clinical trials.

These services work in tandem with back translation to ensure linguistic precision and cross-cultural validity, helping clients meet the expectations of regulatory authorities, ethics committees, and global trial stakeholders.

Frequently Asked Questions

Back translation involves re-translating a completed translation back into the original source language by an independent linguist who has not seen the original text. This reverse translation is compared to the source to assess conceptual equivalence. It is used as a validation step in high-stakes content, unlike standard translation, which only involves rendering content from one language to another.

While not universally mandated, regulatory agencies such as the FDA, EMA, and IRBs often request back translation as part of the linguistic validation process. It is especially important for documents like Patient-Reported Outcomes (PROs), Informed Consent Forms (ICFs), and other patient-facing trial materials to demonstrate accuracy and cross-cultural reliability.

Yes. Sesen supports back translation in over 150 languages, including rare and regional dialects. We work with certified linguists who are fluent in both source and target languages and have expertise in clinical and regulatory domains to ensure the accuracy of every project.

Back translation is frequently applied to clinical outcome assessments (COAs), PRO questionnaires, eCOA screens, informed consent forms (ICFs), patient diaries, recruitment materials, and instructions for use. It may also be used for public health surveys and labeling content that impacts patient understanding or regulatory review.

Turnaround time depends on the document length, language pair, and complexity. Most back translation projects can be completed within 3 to 7 business days. Sesen also supports expedited timelines for time-sensitive clinical trial submissions or regulatory deadlines.

Why Choose Sesen for Back Translation

Sesen is a trusted partner for life sciences organizations seeking accurate, validated, and regulatory-compliant back translation services. Our team combines linguistic precision with deep industry knowledge to support the most demanding clinical and regulatory requirements.

We bring extensive expertise in clinical trial and regulatory translation, with decades of experience working on projects involving PROs, eCOAs, ICFs, labeling, and other patient-facing and submission-critical materials. Our processes are tailored to meet the documentation standards of global regulatory bodies, including the FDA, EMA, and IRBs.

Sesen’s proven workflows scale efficiently across high-volume, multilingual projects, ensuring consistent quality and turnaround times even under compressed timelines. Each back translation is handled with the same attention to detail, regardless of project size or complexity.

We offer full transparency and documentation, including detailed audit trails, reconciliation reports, and validation summaries that support sponsor submissions and regulatory inspections.

To enhance accuracy and efficiency, Sesen integrates AI-enabled QA tools and terminology alignment technology into our workflows. These tools support our linguists by flagging inconsistencies and ensuring alignment with sponsor-approved glossaries and style guides.

Every project is overseen by a dedicated project manager with life sciences expertise, serving as a single point of contact to coordinate resources, monitor progress, and maintain compliance with client requirements.

By partnering with Sesen, clients gain a reliable back translation provider with the specialized knowledge, infrastructure, and quality systems needed to support successful global studies.

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Ensure Linguistic Accuracy and Global Compliance with Sesen’s Back Translation Services

Work with Sesen to deliver back translations that meet the highest standards of clinical and regulatory accuracy. Our expert linguists, ISO-certified workflows, and full documentation support your trial’s success and regulatory acceptance across all target markets.

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