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What Is Translation Reconciliation?

Translation reconciliation is a critical quality assurance step in clinical trial translation and linguistic validation. It involves the systematic comparison and consolidation of two independently produced forward translations to resolve discrepancies and produce a single, harmonized version that accurately reflects the source content.

In global clinical research, translation reconciliation supports the development of patient-facing materials such as Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), and study diaries. It ensures conceptual equivalence across languages and maintains linguistic consistency across regions, which is essential for meeting regulatory expectations and ethics committee requirements.

By aligning terminology, resolving inconsistencies, and documenting justifications for final choices, translation reconciliation strengthens the integrity of multilingual content and improves data reliability across trial sites. This process is a foundational component of regulatory submission workflows and industry best practices in life sciences translation.

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Why Translation Reconciliation Matters

Accurate and consistent translations are essential to the success of global clinical trials. When forward translations lack alignment or conceptual clarity, they can compromise patient comprehension, introduce variability in responses, and result in unreliable data. Without proper reconciliation, inconsistencies may lead to protocol deviations, ethics board rejections, or the invalidation of critical study endpoints.

Translation reconciliation addresses these risks by consolidating two independently produced forward translations into a single, harmonized version. This reconciled version ensures conceptual equivalence with the source text while maintaining linguistic and cultural appropriateness across all target languages.

This process is not only considered best practice but also aligns with regulatory expectations. Authorities such as the FDA and EMA, along with guidelines from ISPOR’s Principles of Good Practice for Translation and Cultural Adaptation, recognize reconciliation as a core component of validated, patient-centered translations. It directly supports the credibility and acceptance of clinical outcome assessments and other translated trial instruments.

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When Is Translation Reconciliation Used?

Translation reconciliation is a key step in the preparation of patient-facing materials for international clinical trials. It is most commonly used during the linguistic validation of Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), study diaries, and clinical questionnaires. The goal is to ensure that the translated content preserves the intent and meaning of the source while remaining culturally and linguistically appropriate for target populations.

This process typically occurs before cognitive debriefing and back translation. It provides a harmonized forward translation that reflects a unified understanding of the source content and serves as the foundation for subsequent validation steps.

Translation reconciliation is also integrated into broader multilingual clinical trial translation workflows. It is frequently performed before ethics committee or Institutional Review Board (IRB) submission to help ensure regulatory compliance, minimize review delays, and support the acceptance of translated study materials across international sites.

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Our Translation Reconciliation Process

At Sesen, we follow a rigorous, multi-step reconciliation workflow to ensure that all translated materials used in clinical trials are accurate, consistent, and regulatory-ready. Each step is executed by qualified linguistic experts in accordance with ISPOR principles and FDA guidance for clinical outcome assessments.

The process begins with the creation of two independent forward translations from the source language. Our linguistic team conducts a side-by-side comparison to identify discrepancies in meaning, phrasing, terminology, and syntax. This initial review allows us to capture different linguistic interpretations and flag potential inconsistencies early in the process.

An experienced reconciliation team, typically composed of native-speaking linguists, in-country reviewers, and therapeutic area experts, convenes to consolidate the two forward translations into a single, unified version. This involves detailed discussions to resolve conceptual differences, select preferred terminology, and ensure that the final forward translation accurately reflects the source content while remaining culturally appropriate for the target audience.

Once the forward translation has been finalized, it is sent to a separate linguist, who translates the text back into the source language. This back translation helps identify any shifts in meaning, omissions, or inaccuracies that may not be apparent through forward translation review alone.

The back-translated version is compared line-by-line with the original source document. Linguists and quality reviewers evaluate whether the reconciled translation retains the intent and meaning of the original. If discrepancies are identified, the forward translation may be refined to correct misunderstandings or improve conceptual alignment.

Every decision made during the reconciliation and review process is documented in a justification log. This includes the rationale for wording choices, resolution of differences, and notes on cultural adaptation. The log serves as a regulatory artifact that supports compliance with FDA, EMA, and IRB requirements and can be included in the trial master file.

What Sets Sesen Apart

Sesen delivers high-quality translation reconciliation services grounded in clinical expertise, regulatory compliance, and scalable multilingual capabilities. Our approach is trusted by sponsors, CROs, and regulatory teams across global clinical trials.

Our translators are native speakers with deep knowledge of therapeutic areas including oncology, rare diseases, CNS, and more. This ensures that all reconciled translations reflect both medical accuracy and cultural relevance.

All reconciliation projects follow ISO 17100 and ISO 9001:2015 certified processes, providing clients with a structured, quality-controlled workflow backed by rigorous documentation and traceability.

Our teams are proficient in medical dictionaries and coding systems such as MedDRA and WHO Drug Dictionary. We apply consistent terminology across all languages to ensure accuracy and alignment with regulatory expectations.

Sesen has supported global trials in over 150 languages, including regional dialects and rare languages. Our teams are experienced in harmonizing translations across large language sets with consistency and efficiency.

We support reconciliation processes that align with electronic patient-reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) systems, as well as Trial Master File (TMF) documentation. Our deliverables are formatted for audit readiness and regulatory submission.

Sample Use Cases

Sesen has supported translation reconciliation across a wide range of therapeutic areas, languages, and regulatory contexts. Below are representative examples of how our reconciliation services help global sponsors ensure translation accuracy and regulatory compliance:

For a multinational Phase III oncology study, Sesen performed translation reconciliation across 26 languages to ensure conceptual consistency in daily patient diaries. The reconciled versions supported ePRO deployment and met the sponsor’s global regulatory submission timelines.

In a pediatric neurology study, Sesen reconciled multiple forward translations of a validated questionnaire to produce harmonized content suitable for children and caregivers across diverse regions. The reconciled version was approved without revision by the institutional review board.

For a patient-reported outcome instrument used in Latin America, our team reconciled Spanish translations from Argentina, Mexico, and Colombia to create a single version that maintained conceptual equivalence while respecting cultural and regional linguistic nuances.

These examples demonstrate how Sesen’s reconciliation process supports the linguistic, regulatory, and clinical integrity of multilingual study materials across global trials.

Frequently Asked Questions

Translation reconciliation is typically required for patient-facing clinical trial materials such as Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), diaries, questionnaires, and instructions for use. It is also commonly applied during linguistic validation to prepare translations for ethics board or regulatory submission.

Sesen applies a centralized, expert-led reconciliation process that standardizes terminology and resolves conceptual discrepancies across all language pairs. All reconciled content is reviewed by native linguists and subject matter experts, and supported by terminology management tools to maintain consistency throughout the study lifecycle.

Yes. We routinely work with client-provided translations and integrate them into our reconciliation workflow. Our team will review, assess, and refine the inputs to produce a final, harmonized version that meets regulatory and quality expectations.

While not required in every study, reconciliation is strongly recommended when linguistic validation is involved or when translated materials are used across multiple sites and languages. It is considered best practice for PRO and COA instruments and is expected by many ethics committees and regulatory bodies.

Yes. Reconciliation can be performed independently as part of a broader translation or localization workflow. However, for full linguistic validation, reconciliation is typically followed by cognitive debriefing to confirm patient comprehension and cultural relevance in the target population.

Related Services

Our translation reconciliation services are integrated with Sesen’s broader suite of clinical trial translation and linguistic validation solutions. Explore related offerings to support end-to-end accuracy and regulatory compliance across multilingual studies:

  • Linguistic Validation Services

    Comprehensive linguistic validation for COAs, PROs, and patient questionnaires, including forward translation, reconciliation, back translation, cognitive debriefing, and final report preparation.

  • Cognitive Debriefing Services

    Interview-based testing with target populations to confirm patient comprehension and cultural relevance of reconciled translations in clinical trial settings.

  • ePRO and eCOA Translation Services

    Specialized translation and adaptation of electronic Clinical Outcome Assessments (eCOAs) and electronic Patient-Reported Outcomes (ePROs), with support for system integration and user interface localization.

  • Patient Diary Translation

    Translation and reconciliation of paper and electronic patient diaries to ensure clarity, consistency, and compliance across languages and regions.

  • Back Translation Services

    Back translation and review services to verify the accuracy of reconciled content and ensure conceptual equivalence with the source material for regulatory readiness.

Ensure Translation Accuracy Across Languages and Trial Milestones

Work with Sesen to deliver consistent, harmonized translations across all clinical trial materials. Our expert reconciliation services help you maintain conceptual accuracy, reduce regulatory risk, and streamline global study workflows.

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