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clinical-trial-translation

Ensuring Accuracy, Compliance, and Patient Safety

Global clinical research hinges on the integrity of both the data collected and the communication pathways established among sponsors, contract research organizations (CROs), investigators, and patients. High-quality translations are integral to this process, as a single misinterpreted phrase can undermine patient safety, skew trial results, or even invalidate an entire study in the eyes of regulatory authorities. Maintaining the accuracy of clinical documentation, such as protocols, informed consent forms (ICFs), case report forms (CRFs), and labeling, directly impacts patient well-being, data reliability, and timely market approvals.

At Sesen, we recognize the stringent demands placed on clinical trial documentation and the potentially far-reaching consequences of translation errors. Our teams of specialized translators and multilingual medical experts are adept at navigating the complex terminology and regulatory frameworks that govern life sciences. Whether it’s adhering to guidelines set forth by the International Council for Harmonisation (ICH), conforming to Good Clinical Practice (GCP) standards, or ensuring compliance with regional health authorities (e.g., FDA, EMA, MHRA), we employ rigorous processes and industry-best practices to safeguard the accuracy of every translated document.

By leveraging advanced translation technologies, including Translation Memory (TM) systems, terminology management tools, and secure collaboration platforms, we ensure consistent, high-quality output across all stages of a clinical trial. Coupled with our deep subject matter expertise and unwavering commitment to quality assurance, Sesen’s approach minimizes the risk of misinterpretation and regulatory setbacks. From patient enrollment materials to final regulatory submissions, our mission is to protect patient safety, preserve data integrity, and expedite global study timelines through translations that meet the highest standards of precision and professionalism.

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Explore Our Clinical Trial Translation & Linguistic Validation Services

Sesen provides end-to-end translation and localization support across every stage of the clinical trial lifecycle. From early study startup to final close-out documentation, our expert linguists and regulatory specialists deliver accurate, compliant translations in over 150 languages. Explore our specialized services below to see how we help sponsors, CROs, and sites run successful global studies with clarity, speed, and confidence.

Set your study up for success with accurately translated documentation that meets regulatory expectations and enables fast site activation.

  • Clinical Trial Protocol Translation
    Translate study protocols with clinical and scientific accuracy across global sites to support consistent trial execution and facilitate regulatory review across regions.
  • Investigator Brochure Translation
    Localize investigator brochures to ensure clear understanding of study rationale, objectives, and safety data at all participating sites.
  • Site Feasibility Questionnaire Translation
    Accurately translate feasibility surveys to support site qualification, capacity evaluation, and consistent site selection across regions.
  • Clinical Trial Registry Entry Translation
    Translate registry content for platforms like ClinicalTrials.gov, EudraCT, and WHO ICTRP to meet public disclosure and transparency mandates.
  • Informed Consent Form (ICF) Translation
    Translate ICFs with sensitivity to cultural and linguistic nuances to promote participant comprehension, ethical compliance, and IRB approval.
  • Site Training Materials Translation
    Provide multilingual SOPs, slide decks, and onboarding guides to help investigator teams align with GCP standards and study-specific procedures.

Deliver clear, localized content to improve patient adherence and data quality throughout the study.

  • Informed Consent Form (ICF) Translation
    Localize ICFs into target languages to ensure participants fully understand trial objectives, procedures, risks, and rights before enrollment.
  • Patient Recruitment & Retention Material Translation
    Translate brochures, flyers, digital ads, emails, and community outreach materials to effectively recruit and retain participants across diverse populations.
  • Patient Diary Translation
    Translate paper-based, eDiary, and electronic patient-reported outcome instruments to preserve data accuracy and consistency across languages.
  • Linguistic Validation
    Adapt and test translated PROs and questionnaires through standardized multi-step validation including forward translation, back translation, interviews with target patients to ensure conceptual equivalence and clarity.
  • Cognitive Debriefing Services
    Conduct interviews with patients to validate that translated materials are clear, culturally appropriate, and well understood.
  • Home-Use Kit Instruction Translation
    Translate clear, easy-to-follow instructions for at-home drug administration or device use to ensure safety and compliance.
  • Patient Logbook Translation
    Localize self-reporting tools for accurate documentation of medication use, symptoms, or adherence tracking.
  • Multimedia eLearning Module Translation for Patients
    Translate onboarding videos and digital learning modules to educate and engage trial participants in their own language.

Comprehensive support for multilingual regulatory interactions that ensure compliance and transparency.

  • Regulatory Submission Document Translation
    Translate technical regulatory files (CTD, eCTD, 1572) for global submission packages in compliance with ICH guidelines.
  • IRB Communication Translation
    Translate submission documents, approval letters, and ongoing correspondence with ethics committees across jurisdictions.
  • Clinical Trial Agreement (CTA) & Site Contract Translation
    Localize legal agreements to ensure enforceability, clarity, and mutual understanding between sponsors and sites.
  • DSMB Report Translation
    Provide data safety monitoring boards with timely, accurate translations of interim safety and efficacy reports.
  • Serious Adverse Event (SAE) Report Translation
    Translate SAE reports accurately and efficiently to meet pharmacovigilance reporting standards and timelines across global regions.
  • Adverse Event (AE) Report Translation
    Localize AE reports for compliance with regional safety monitoring and documentation requirements in global trials.

Accurate translations of clinical trial documents to maintain consistency, traceability, and audit readiness across all phases.

  • Case Report Form (CRF) Translation
    Harmonize CRF content across study sites to support consistent clinical data collection and submission readiness.
  • Source Document Translation
    Translate original patient records, site notes, and medical charts to enable reliable data verification and audits.
  • Clinical Study Report (CSR) Translation
    Translate final study reports with scientific precision and formatting alignment for regulatory submission and publication.
  • Clinical Trial Training Material Translation
    Translate investigator training modules, videos, and SOPs to support global GCP compliance and protocol adherence.
  • Study Close-Out Report Translation
    Translate final summaries, logs, and reconciliations to support study closure documentation and sponsor audits.

Specialized services to validate translation quality, ensure regulatory consistency, and support multilingual trial compliance.

  • Linguistic Validation
    Perform standardized multi-step validation of translated COA instruments (PRO, ClinRO, ObsRO) to ensure regulatory compliance.
  • Cognitive Debriefing Services
    Conduct structured interviews with patients to confirm translated materials are clear, culturally appropriate, and well understood.
  • Back Translation Services
    Independently translate content back into the source language to verify accuracy and identify discrepancies.
  • Translation Reconciliation Services
    Resolve inconsistencies between independent translations to generate a harmonized final version for regulatory use.
  • Independent Translation Audit
    Conduct third-party linguistic reviews to verify accuracy, adherence to terminology, style consistency, and regulatory compliance.
  • Glossary & Style Guide Development
    Build custom glossaries and linguistic style guides to ensure brand, terminology, and tone consistency across studies.
  • Parallel Review / Blinded Translation Validation
    Compare two or more forward translations to validate conceptual alignment and eliminate translator bias in sensitive materials.
  • Submission-Ready QA & Formatting (DTP + PDF)
    Prepare translated files with compliant layout, metadata, and formatting for seamless eCTD or PDF-based submission.

Sesen’s Methodology for World-Class Clinical Translations

At Sesen, every translation project is handled by expert linguists with a proven background in life sciences. Our team includes professional native translators who understand the nuances of clinical research protocols and regulatory language in addition to having extensive experience in medical and pharmaceutical terminology. This specialized knowledge ensures that complex concepts and critical data points remain linguistically accurate and technically precise in every target market.

To maintain unwavering standards of precision, we adhere to ISO-certified workflows (ISO 9001, ISO 13485, ISO 17100) that govern each step of our translation process. After an initial translation, documents undergo independent proofreading and editing by a second expert. In highly sensitive or legally binding materials, we incorporate back translation to verify the original meaning. These rigorous checks minimize the risk of errors and guarantee the highest quality output for clinical trials and related documentation.

Sesen leverages advanced translation technology, including Translation Memory (TM) and terminology management on our intelligent, secure cloud-native translation management platform, to streamline our processes and ensure consistent, high-quality translations across all your project documents. We also develop custom glossaries to capture client-specific product names, branding, and technical terms, which further improves both accuracy and turnaround times. By combining cutting-edge technology with human expertise, we deliver seamless multilingual support for global clinical trials.

Recognizing the sensitivity of clinical trial data, we implement robust security measures and sign NDAs to protect client information at all stages of the project. Our platforms and workflows comply with international data protection regulations, such as GDPR and HIPAA, ensuring that patient information and proprietary study data remain fully secure. With Sesen as your partner, you can be confident that your clinical trial documentation is translated accurately, efficiently, and with the utmost confidentiality.

Linguistic Validation & Cultural Adaptation

High-quality translations in clinical trials go beyond literal word conversion from one language to another. Linguistic validation is crucial for patient questionnaires, Patient-Reported Outcomes (PROs), and other instruments that measure subjective health experiences. This multi-step process typically involves forward-back translation, consensus review, and cognitive debriefing sessions with representative populations. By following industry standards, including guidelines from organizations like the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Sesen ensures these critical documents retain both conceptual and contextual equivalence across languages.

Equally important is cultural adaptation, where linguistic choices account for local customs, beliefs, and health literacy levels. Patient-facing materials must be easily understood, culturally respectful, and relevant to diverse demographics. This includes selecting appropriate terminology, adjusting date and measurement formats, and considering any potential sensitivities around medical topics. By adapting content in ways that resonate with local audiences, Sesen helps sponsors avoid misinterpretation that could lead to inaccurate data or compromised patient safety.

Together, linguistic validation and cultural adaptation contribute to higher patient engagement and improved retention rates in global studies. Participants who fully comprehend the study requirements and procedures are more likely to adhere to trial protocols and remain committed throughout the study. Ultimately, these best practices safeguard the integrity of clinical data and foster a positive patient experience, two key elements for the success of any international clinical trial.

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eCOA, ePRO & Mobile App Translation

Sesen specializes in the translation and linguistic validation of electronic clinical outcome assessments (eCOA), including ePRO, ClinRO, and ObsRO instruments delivered via mobile, tablet, or web platforms. Our services cover:

  • Screenshot validation in all target languages
  • Early-stage feasibility assessments for character limits and UI display
  • Collaboration with eCOA platform vendors to streamline implementation

Our eCOA translation workflows help sponsors and CROs reduce back-and-forth with vendors, accelerate localization timelines, and ensure regulatory acceptance across global study sites. To learn more about Sesen’s comprehensive eCOA translation solutions, explore our specialized eCOA translation services.

AI-Assisted Workflows Powered by SesenGPT

We leverage SesenGPT, our proprietary AI-enhanced linguistic platform, to support faster, more consistent clinical trial document translation workflows, without compromising quality. Key benefits include:

  • Faster turnaround times through assisted draft generation
  • Improved cost-efficiency for high-volume or multi-language projects
  • Higher consistency in terminology and formatting across related documents
  • Human validation by professional native linguists for regulatory-grade accuracy

SesenGPT combines the efficiency of AI with the accuracy of expert linguists — delivering faster, smarter translations for even the most complex clinical trial documentation.

Regulatory-Ready Validation Process

Our clinical translation workflows are aligned with FDA, EMA, and PMDA expectations for PRO and eCOA instruments. Each project includes:

  • Forward and back translation
  • Reconciliation by senior linguists
  • Clinician review (as needed)
  • Cognitive debriefing with target population
  • Final proofreading and formatting for submission-readiness

Sesen adheres to ISO 17100 and ISO 9001:2015 standards, ensuring documentation integrity and consistency from study startup through regulatory submission.

Platform-Compatible Translation Workflows

Sesen’s translation management system is a flexible, API-enabled workflow engine purpose-built for life sciences. Designed to work seamlessly with your existing infrastructure, including Veeva Vault, eTMF systems, eCOA platforms, and other clinical content management tools, our system supports high-volume document localization with regulatory-grade precision and transparency.

We offer:

  • Custom workflow routing based on study phase, document type, and target region
  • Regulatory-compliant audit trails with time-stamped change logs
  • Translation status dashboards by document, site, and language
  • Export-ready files compatible with common eTMF and regulatory submission platforms

Whether you’re managing translations for an IND submission, a global Phase III trial, or a patient-facing mobile app, Sesen’s system provides the visibility and control you need, without the burden of adopting a new enterprise suite.

Partnering with Pharma, Biotech, and CROs Worldwide

Sesen delivers multilingual support for every phase of the drug development process, from preclinical studies to post-marketing surveillance. Our experienced translators and medical experts ensure regulatory documents, informed consent forms, clinical trial protocols, and labeling materials meet the highest quality and compliance standards. By combining in-depth industry knowledge with advanced translation technologies, we help pharmaceutical sponsors streamline their global operations and bring life-saving medications to market faster.

Biotech innovations, such as gene therapies and advanced biologics, demand a high level of technical sophistication. Sesen’s specialized linguists are adept at translating complex scientific data, research findings, and product documentation with utmost precision. Whether it’s for patent filings, investor presentations, or regulatory submissions, our specialized team safeguards the scientific integrity of your content while adapting materials for diverse global audiences.

As CROs often manage clinical trials on behalf of multiple sponsors, consistent, reliable translations are critical to maintaining operational excellence. Sesen provides end-to-end language solutions, covering study start-up, patient recruitment, site training, and final reporting. By leveraging ISO-certified workflows and secure translation management platforms, we ensure that your documentation remains confidential, accurate, and on schedule, no matter how many languages or trial sites are involved.

From device manuals and Instructions for Use (IFUs) to labeling and regulatory documentation, medical device translations must be both technically accurate and accessible to end users. Sesen’s teams are well-versed in international regulations, including EU MDR and FDA requirements, ensuring product materials meet local compliance standards. Whether you’re distributing wearables, implants, or diagnostic equipment, our culturally adapted translations help maximize user safety, product credibility, and global market success.

Proven Track Record in Clinical Trial Translations

Below are anonymized examples of successful clinical translation projects we completed in partnership with a leading global CRO (referred to here as “the CRO”) for major pharmaceutical and biotech clients. These cases highlight how Sesen’s expertise helped improve enrollment, enhance regulatory compliance, and expedite study timelines.

Case Study 1: Multi-Country Phase III Oncology Trial
  • Challenge:
    The CRO was managing a late-stage oncology trial involving patient enrollment across more than 15 countries in Europe and Asia. They required rapid, high-quality translations of study protocols, informed consent forms, and patient recruitment materials, all under tight regulatory timelines.
  • Sesen’s Approach:
    • Deployed a team of specialized medical translators with oncology backgrounds.
    • Utilized ISO-certified processes (ISO 17100) to ensure accuracy and consistency.
    • Conducted expedited linguistic validation for patient-facing materials to maintain clarity and cultural relevance.
  • Outcome:
    Thanks to our streamlined workflows and use of secure translation management technology, the CRO completed translations ahead of schedule, expediting regulatory submissions. Patient enrollment targets were met earlier than projected, and sponsors reported improved patient comprehension and compliance.
  • Client Feedback:
    “Sesen’s rapid turnaround and subject matter expertise were critical in meeting our enrollment targets. Their attention to detail ensured our oncology trial materials were both compliant and patient-friendly.”
    – Associate Director, Clinical Operations
  • Challenge:
    The CRO needed specialized translations for a rare disease clinical trial’s Patient-Reported Outcome (PRO) instruments, which included highly technical terms and culturally sensitive questions. Ensuring consistent terminology and patient engagement across 10 languages was essential for collecting reliable data.
  • Sesen’s Approach:
    • Conducted a thorough glossary creation process in collaboration with the CRO and sponsor, capturing disease-specific terminology.
    • Performed forward-back translation and cognitive debriefing sessions to validate the PRO instruments, following best practices from ISPOR.
    • Provided ongoing support to incorporate mid-study updates to the questionnaires without disrupting the overall study timeline.
  • Outcome:
    The data collected through these validated PRO instruments remained consistent across all participating regions, helping the sponsor demonstrate clear efficacy outcomes to regulatory bodies. By minimizing errors and enhancing participant understanding, the trial maintained strong patient engagement, ultimately expediting the approval process.
  • Client Feedback:
    “Our team appreciated Sesen’s rigorous validation process. The translations were highly accurate, and the seamless integration of changes during the trial made our job much easier.”
    – Global Project Manager, Rare Disease Program

Clinical Trial Translations FAQ

Yes. At Sesen, we offer certified and sworn translations, depending on regional requirements, to ensure full compliance with health authorities such as the FDA, EMA, and other international regulatory bodies. Our certification process includes thorough quality checks and official endorsements, providing an additional layer of credibility and assurance for your submissions.

We adhere to ISO-certified workflows (including ISO 9001, ISO 13485, and ISO 17100) that govern each phase of our translation and review process. Every project undergoes independent proofreading and editing by subject matter experts, ensuring the highest level of precision and consistency for clinical documentation.

Absolutely. Sesen’s extensive global network of professional linguists, combined with our cloud-based translation management platform, allows us to manage large-scale, multi-language projects in parallel. This capability accelerates turnaround times and maintains consistency across all languages.

We implement stringent security measures at every stage of our workflow. Our translators and project managers are bound by Non-Disclosure Agreements (NDAs), and all data is stored on secure, encrypted servers that comply with GDPR, HIPAA, and other data protection regulations. This approach safeguards patient privacy, proprietary trial data, and intellectual property.

We understand that clinical trial timelines can be unpredictable. Our flexible project management teams and streamlined workflows allow us to accommodate rush requests without compromising quality. Depending on the scope, we can assign additional resources or work in extended shifts to meet your tight deadlines.

Yes. We work with linguists who possess in-depth knowledge of specific therapeutic fields, from oncology and immunology to rare diseases and medical devices. Their expertise ensures correct usage of complex terminology, context-appropriate language, and compliance with relevant industry standards.

Clinical trials often evolve, requiring changes to protocols, patient materials, or regulatory documents. Sesen’s agile translation process and version-control systems allow us to efficiently incorporate these updates. We ensure consistency and accuracy by referencing previously approved terminology, glossaries, and style guides throughout the project.

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