Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.

No, thanks

BOOK A MEETING BOOK A MEETING
Sign In

Why PRO and Questionnaire Translation Matters

Patient-Reported Outcomes (PROs) and patient-facing questionnaires are essential tools for capturing the patient’s voice in clinical trials. They provide direct insights into symptoms, treatment impact, and quality of life, making them critical for evaluating drug efficacy and safety from the patient perspective.

Accurate translation of these instruments is not simply about linguistic conversion. It requires rigorous linguistic validation to preserve conceptual equivalence across languages, ensuring that translated content measures the same constructs as the original. Cultural adaptation is equally important to ensure patient comprehension and engagement across diverse populations.

Global regulatory authorities, including the FDA, EMA, and PMDA, require that translated PRO instruments meet specific validation and documentation standards. Adherence to ICH E6/E8 guidelines and ISO 14155 ensures that patient-reported data remains credible and defensible in regulatory submissions.

As clinical trials expand into more countries and regions, sponsors increasingly rely on validated translations to maintain data consistency and integrity across study sites. High-quality PRO and questionnaire translation services help ensure meaningful patient input, accelerate regulatory approval, and support successful global trial outcomes.

Read More Read Less

Validated Translation Services for PRO Instruments and Clinical Questionnaires

Sesen provides validated translation services for PRO instruments and clinical questionnaires used in global clinical trials. Our solutions ensure conceptual integrity, regulatory compliance, and patient comprehension across languages and cultures.

We perform regulatory-focused linguistic validation to ensure each PRO instrument maintains conceptual integrity across languages.

  • Conceptual equivalence verification to ensure that clinical constructs are preserved across all language versions
  • Cognitive debriefing with target populations to test clarity and cultural relevance in real-world settings
  • Harmonization of multilingual translations to maintain consistency in global studies involving multiple countries
  • Regulatory-compliant documentation prepared for FDA, EMA, PMDA, and ethics committees to support validation and approval

Our translation workflows follow industry best practices to ensure linguistic accuracy and functional usability across all patient-facing instruments.

  • Forward translation, back translation, and reconciliation performed by native linguists and medically trained reviewers
  • In-context review of instructions, Likert scales, and answer formats to maintain consistency and usability across languages
  • Formatting for both paper-based and electronic questionnaires including layout optimization for ePRO and eCOA platforms

We offer translation and localization for all delivery formats to support patient engagement across literacy levels and device types.

  • In-app UI localization of screen text, instructional messages, and navigation elements for digital data collection tools
  • Voiceovers and subtitles for multimedia questionnaires designed for low-literacy or multilingual patient populations
  • Translation for print, web, and mobile formats to support hybrid trial models and remote data capture

Regulatory-Compliant Translation Workflow for PRO Instruments and Questionnaires

Sesen applies a regulatory-compliant translation workflow specifically designed for PRO instruments and clinical questionnaires used in global clinical trials. Our process meets the validation standards of health authorities such as the FDA, EMA, and PMDA, ensuring conceptual equivalence, linguistic accuracy, and documentation readiness for regulatory submission.

We assess the source instrument to understand the clinical intent, complexity, and cultural sensitivity. Scope is defined based on language pairs, mode of delivery, and regulatory requirements.

Two independent native-speaking linguists translate the source instrument into the target language, maintaining clinical accuracy and patient-friendly phrasing.

A separate linguist, blinded to the source, translates the draft back into the original language. This helps identify discrepancies in meaning or terminology.

Our medical linguists and project leads compare the forward and back translations to harmonize the final version, resolving differences and preserving conceptual intent.

Target-language participants evaluate the translated instrument for clarity, relevance, and comprehension. Results are documented to support linguistic validation.

Clinical experts or platform developers review the translated content to confirm medical accuracy and proper integration into digital platforms or paper forms.

Final language checks are conducted to verify formatting, consistency, and terminology alignment. Our QA team ensures the deliverable is clean and complete.

We compile all required documentation to support regulatory inspection and approval. This includes certificates of translation accuracy, back translation reports, cognitive debriefing summaries, and final reconciliation files, formatted for submission to agencies such as the FDA, EMA, and PMDA.

Technology-Assisted Human Translation

At Sesen, we combine advanced translation technology with human subject matter expertise to deliver accurate, scalable, and regulator-ready translations of PRO instruments and clinical questionnaires.

We leverage translation memory (TM) and customized terminology glossaries to ensure linguistic consistency across all patient-facing content. These tools reduce redundancy, maintain standardized phrasing, and support faster turnaround times without compromising quality.

Our workflow integrates directly with sponsor and CRO platforms, including leading ePRO and eCOA systems, to streamline the localization of in-app text, user prompts, and clinical instructions. This ensures proper formatting, functional compatibility, and a seamless user experience across digital interfaces.

All translation activities are performed in a secure, cloud-based environment hosted on AWS, supporting enterprise-grade data protection, role-based access control, and audit trail documentation. This infrastructure helps safeguard sensitive clinical and patient information in compliance with global privacy regulations.

For projects requiring accelerated delivery, we offer optional Machine Translation Post-Editing (MTPE) performed by professional native linguists. This hybrid approach maintains data accuracy and readability while reducing turnaround time for large-scale studies or urgent updates.

Read More Read Less

Specialized PRO Translation Expertise Across Therapeutic Areas

Sesen supports PRO and clinical questionnaire translation across a broad range of therapeutic areas, enabling sponsors to capture accurate, patient-reported data across diverse global populations. Our linguists and medical experts are trained in condition-specific terminology and understand the sensitivity required for each therapeutic context.

We have extensive experience translating and validating standardized and custom PRO instruments for:

  • Central nervous system (CNS) and psychiatry studies, including depression and anxiety scales such as HAM-D, MADRS, and PANSS
  • Pain, fatigue, sleep, and symptom burden assessments used across chronic illness, rehabilitation, and palliative care trials
  • Oncology, dermatology, ophthalmology, and respiratory studies requiring validated patient-facing instruments for clinical endpoints and treatment feedback
  • Rare disease studies, including translation of bespoke patient diaries, qualitative interviews, and customized instruments with limited source standardization

Our team works closely with sponsors and clinical developers to ensure every instrument retains conceptual integrity and regulatory alignment across all target languages.

Read More Read Less

Regulatory Compliance and Submission-Ready Documentation

Sesen delivers fully validated PRO and questionnaire translations that meet the rigorous documentation standards required by global regulatory bodies, including the FDA, EMA, and PMDA. Our process ensures every language version is defensible, traceable, and ready for inclusion in clinical trial submissions.

We provide comprehensive documentation to support regulatory inspections, ethics committee reviews, and sponsor audits, including:

  • Submission-ready files formatted to meet agency-specific requirements, including tracked changes, certified translations, and harmonized language sets
  • Annotated translation reports detailing key linguistic decisions, cultural adaptations, and medical terminology choices for each instrument
  • Certificates of Translation Accuracy (CTA) signed by qualified linguists to verify the completeness and accuracy of each translated version
  • Translatability assessments and reviewer feedback summaries conducted during early instrument development to identify language challenges and confirm global applicability

Our documentation aligns with ICH guidelines and ISO quality standards to ensure your PRO instruments are fully compliant and audit-ready across all study regions.

Read More Read Less

Seamless ePRO and eCOA Platform Integration

Sesen specializes in the translation and validation of PRO instruments and clinical questionnaires for electronic platforms, including ePRO and eCOA systems. We work directly within digital trial environments to ensure that localized content is accurate, functional, and contextually appropriate across all devices and user interfaces.

Our team has experience integrating translations into leading eClinical systems such as Medidata, Veeva, TrialMax, Castor, and others, supporting sponsors and CROs in deploying global studies with confidence.

We provide:

  • Full QA testing of translated content within ePRO and eCOA platforms to identify display, formatting, and functional issues before deployment
  • In-context UI preview and validation to assess the placement, truncation, and readability of localized items in their digital environment
  • Screen-by-screen linguistic review by native-speaking clinical linguists to confirm clarity, accuracy, and user comprehension across all language versions
  • Collaboration with platform developers to resolve technical localization challenges and maintain synchronization with platform updates or revisions

By combining clinical translation expertise with technical platform fluency, Sesen ensures that all patient-facing content in digital trial systems is ready for real-world use, compliant with regulatory standards, and optimized for global accessibility.

Read More Read Less

Seamless ePRO and eCOA Platform Integration

Sesen specializes in the translation and validation of PRO instruments and clinical questionnaires for electronic platforms, including ePRO and eCOA systems. We work directly within digital trial environments to ensure that localized content is accurate, functional, and contextually appropriate across all devices and user interfaces.

Our team has experience integrating translations into leading eClinical systems such as Medidata, Veeva, TrialMax, Castor, and others, supporting sponsors and CROs in deploying global studies with confidence.

We provide:

  • Full QA testing of translated content within ePRO and eCOA platforms to identify display, formatting, and functional issues before deployment
  • In-context UI preview and validation to assess the placement, truncation, and readability of localized items in their digital environment
  • Screen-by-screen linguistic review by native-speaking clinical linguists to confirm clarity, accuracy, and user comprehension across all language versions
  • Collaboration with platform developers to resolve technical localization challenges and maintain synchronization with platform updates or revisions

By combining clinical translation expertise with technical platform fluency, Sesen ensures that all patient-facing content in digital trial systems is ready for real-world use, compliant with regulatory standards, and optimized for global accessibility.

Read More Read Less

Why Leading Life Sciences Companies Choose Sesen

Sesen is a trusted partner for global pharmaceutical, biotech, and CRO teams seeking validated translation solutions for PRO instruments and clinical questionnaires. Our singular focus on life sciences ensures every project meets the highest standards of linguistic accuracy, regulatory compliance, and patient-centered clarity.

Sesen specializes exclusively in life sciences translation, ensuring every project is handled by linguists and project managers with deep domain expertise in clinical trials, regulatory documentation, and patient communications.

We have supported PRO instrument translation and linguistic validation for multinational studies across oncology, CNS, rare diseases, and other therapeutic areas, helping sponsors meet regulatory expectations and enhance patient engagement.

Our teams combine native linguistic fluency with medical training to deliver translations that are both culturally appropriate and clinically accurate, aligned with the scientific intent of each instrument.

Sesen enables global reach with translation and validation support in over 150 languages, maintaining consistency, quality, and readability across all patient-facing materials.

Our certified quality management systems ensure compliance with international standards for translation services, medical device documentation, and organizational performance.

Each client is assigned a dedicated project manager to oversee timelines, quality, and communication. We offer flexible engagement models including per-language, per-document, and full-time-equivalent (FTE) support tailored to your study needs.

Sesen delivers scalable, audit-ready translation solutions that accelerate study timelines, enhance patient comprehension, and support successful regulatory submissions.

Real-World Results: Validated PRO Instrument in 18 Languages for a Global Oncology Trial

A top-tier biopharmaceutical company engaged Sesen to translate and validate a cancer-specific PRO instrument across 18 languages for use in a multicountry Phase III clinical trial. The project required strict adherence to FDA and EMA guidelines, with full linguistic validation, cognitive debriefing, and regulatory documentation for each language version.

Sesen’s team of native linguists, medical reviewers, and regulatory experts worked closely with the sponsor to ensure all patient-facing content was conceptually equivalent, culturally adapted, and submission ready. The translations were integrated directly into the client’s ePRO platform, with in-context screen-by-screen validation and QA testing to ensure functional accuracy.

Client Testimonial

“Sesen ensured our PRO instrument met all regulatory and linguistic validation standards. Their team was responsive, thorough, and instrumental in our global trial rollout.”

— Global Clinical Operations Lead, Biopharma Sponsor

Need Expert PRO and Clinical Questionnaire Translation Support?

Work with Sesen to translate and validate PRO instruments and patient questionnaires with precision and speed. Our team delivers compliant, culturally adapted translations in over 150 languages—ready for regulatory submission and global deployment.

REQUEST A QUOTE REQUEST A QUOTE
CONTACT US CONTACT US
EXPLORE CLINICAL TRANSLATION SERVICES EXPLORE CLINICAL TRANSLATION SERVICES

Complementary Clinical Translation Services

Explore additional Sesen services that complement PRO and clinical questionnaire translation. Our integrated solutions help sponsors streamline multilingual content delivery across every stage of the clinical trial lifecycle.

Ensure conceptual equivalence and cultural relevance with Sesen’s structured validation process. We offer forward and back translation, reconciliation, and cognitive debriefing tailored to clinical instruments.

Learn more on our Linguistic Validation Services page.

We translate and validate content for leading eClinical platforms, ensuring screen-based clarity, functional integrity, and global accessibility for digital data collection tools.

Visit our ePRO and eCOA Localization page for details.

Improve trial enrollment and retention with culturally adapted patient-facing content. Sesen supports translation of recruitment materials, diaries, reminders, and multimedia assets.

See how we help on the Patient Engagement Localization page.

From protocols to site documents, we provide validated translations that meet regulatory and operational requirements across every stage of your trial.

Explore full capabilities on our Clinical Trial Translation Services page.

Deliver informed consent documents in multiple languages with clarity and compliance. We provide IRB-ready translations formatted for electronic platforms.

Learn more on the eConsent Translation Services page.