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What Are ePROs?

Electronic Patient-Reported Outcomes (ePROs) are the digital version of traditional PRO instruments used in clinical trials to capture direct input from patients about their symptoms, treatment experience, and quality of life. Delivered via smartphones, tablets, or web-based platforms, ePROs are a core component of modern eCOA systems and play a critical role in collecting reliable, patient-centered data across diverse regions.

As clinical trials expand globally, the accurate translation and cultural adaptation of ePRO instruments are essential to ensure consistent comprehension and data integrity across languages. Poorly translated items can lead to misinterpretation, reduced patient engagement, or invalidated trial results.

Sesen provides specialized ePRO translation services and ePRO linguistic validation to support sponsors, CROs, and eCOA vendors in delivering compliant and culturally appropriate ePRO content. Our team of native linguists and clinical experts localizes ePRO instruments with precision, aligning with regulatory expectations and best practices for clinical trial instrument localization.

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Why ePRO Translations Matter

Accurate ePRO translation is essential to the integrity of global clinical trials. Electronic Patient-Reported Outcomes are often used to assess primary or secondary endpoints, making them directly influential in evaluating treatment efficacy and patient safety. Any discrepancies in translation can compromise data quality, trigger re-consent, or delay regulatory approval.

Global health authorities such as the FDA, EMA, PMDA, and NMPA require properly validated translations of ePRO instruments to ensure patient comprehension and equivalence across languages. Regulatory guidelines emphasize that all translated content must maintain conceptual meaning and cultural relevance without introducing bias.

Sesen’s ePRO translation services and ePRO linguistic validation workflows are built to meet these expectations. We apply industry standards, including ISPOR guidelines, to deliver compliant, patient-friendly translations that preserve the intent of each item while enabling consistent data collection across global sites.

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Our ePRO Translation and Validation Workflow

Sesen follows a rigorous, standardized workflow for ePRO translation and linguistic validation to ensure regulatory compliance, patient comprehension, and global consistency. Our process supports both proprietary and public-domain instruments and is aligned with ISPOR/ISPE best practices and FDA PRO Guidance.

Each step is managed by professional native linguists with experience in clinical content and medical terminology.

We begin by reviewing the source ePRO instrument, assessing clinical context, licensing requirements, and technical format. We collaborate with sponsors and eCOA vendors to define the scope and validation pathway.

Two independent native-speaking linguists translate the ePRO content from the source to the target language. Translations prioritize conceptual equivalence, cultural appropriateness, and clinical accuracy.

A senior linguist compares both forward translations and merges them into a single reconciled version that reflects the most accurate and natural rendering of the original text.

The reconciled translation is translated back into the source language by a third linguist to verify fidelity to the original meaning. This step is used for quality control and regulatory documentation.

We test the translated instrument with native-speaking patients from the target population to assess clarity, comprehension, and cultural suitability. Feedback is used to refine the translation.

If the ePRO instrument is licensed or proprietary, we facilitate reviews and approvals with the instrument owner or developer to ensure compliance with licensing terms.

We deliver the finalized translation along with supporting documents such as translation certificates, linguistic validation reports, and cognitive debriefing summaries to support submission to regulatory bodies.

Supported ePRO Instrument Types

Sesen supports the translation and validation of a wide range of ePRO instruments used in clinical trials across therapeutic areas. Our ePRO translation services are designed to maintain the integrity of patient responses while meeting regulatory and linguistic validation standards.

We translate both general and disease-specific instruments, ensuring conceptual accuracy and usability for diverse patient populations.

Common ePRO Use Cases We Support:

Daily logs tracking patient-reported symptoms such as pain, nausea, fatigue, and sleep disturbance

Validated tools like the SF-36, EQ-5D, and WHOQOL used to assess overall patient well-being during and after treatment

Questionnaires that evaluate physical, emotional, and social functioning, including mobility and daily activity limitations

Instruments tailored to specific therapeutic areas, including:

  • Asthma control assessments
  • Oncology-related symptom tracking
  • Central nervous system (CNS) evaluations
  • Dermatology and skin condition scales
  • Rheumatology and musculoskeletal measures

We support both proprietary and public-domain instruments and can coordinate directly with license holders or instrument developers when required. Our team ensures full alignment with licensing terms and regulatory expectations throughout the localization process.

Compatible with All Major eCOA Platforms

Sesen’s ePRO translation services are fully compatible with leading electronic Clinical Outcome Assessment (eCOA) platforms used in global clinical trials. We work seamlessly with eCOA providers to localize patient-facing content directly within platform environments or through structured localization files.

Our technical team supports a wide range of digital delivery formats and platform-specific requirements to ensure efficient implementation, consistent formatting, and error-free data capture across languages.

Supported Platforms Include:

  • Medidata
  • Veeva ePRO
  • Clario
  • ERT (now part of Clario)
  • TrialSlate
  • Signant Health

We support platform integration through localization-ready file types including XML, Excel, JSON, and proprietary platform formats. Whether your trial uses BYOD, provisioned devices, or web-based data capture, Sesen ensures translated content displays correctly, functions smoothly, and aligns with user experience standards in all target languages.

Case Example: Phase III Oncology Trial

A global biopharmaceutical company engaged Sesen to support the multilingual rollout of an electronic Patient-Reported Outcome (ePRO) instrument for a Phase III oncology clinical trial. The study evaluated a novel immunotherapy across multiple countries and required rapid, high-quality localization of a daily symptom diary used to assess treatment-related side effects.

Project Scope:

  • Study Phase: Phase III
  • Therapeutic Area: Oncology
  • Languages: English to French, German, Spanish, Simplified Chinese
  • Deliverables:
    • Dual forward translations by native linguists
    • Reconciliation and back translation
    • Cognitive debriefing with native speakers
    • Final ePRO content formatting and platform-ready file delivery

Sesen collaborated closely with the sponsor’s eCOA vendor to ensure all translations were properly integrated into the digital platform and met formatting and display requirements.

Results:

  • All translated versions passed cognitive debriefing with strong patient comprehension scores
  • Full linguistic validation documentation was submitted and accepted by regulatory authorities without queries
  • The sponsor reported a 20 percent reduction in translation cycle time compared to previous providers, enabling faster study startup across multilingual sites

This case highlights Sesen’s ability to deliver accurate, compliant, and patient-centered ePRO translation services under tight timelines and high regulatory scrutiny.

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What About Paper-Based PRO Instruments?

While electronic Patient-Reported Outcomes (ePROs) have become the preferred format in modern clinical trials, many studies still rely on traditional paper-based PRO instruments due to regulatory requirements, site limitations, or legacy protocol designs.

Sesen provides comprehensive translation and linguistic validation services for both electronic and paper-based PROs. Our workflows for paper instruments follow the same rigorous quality standards, including dual forward translation, reconciliation, back translation, cognitive debriefing, and preparation of regulatory documentation.

We ensure full compliance with global health authority expectations and coordinate directly with instrument developers or license holders as needed. Whether your study involves hybrid formats or fully paper-based instruments, Sesen delivers accurate, patient-friendly translations that support consistent data collection across languages and sites.

Our paper-based PRO translation services are ideal for post-marketing studies, decentralized trials in low-connectivity regions, and instruments not yet digitized for eCOA platforms.

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Quality Assurance and Regulatory Compliance

Sesen delivers ePRO translation services with a strong focus on quality, consistency, and global regulatory compliance. Our processes are certified to ISO 17100 and ISO 9001 standards, ensuring systematic quality control and traceability across all translation and validation steps.

We produce submission-ready deliverables that meet the expectations of global regulatory agencies including the FDA, EMA, PMDA, and NMPA. All translations undergo multiple layers of linguistic review and validation to support data reliability and audit readiness.

Our in-country linguistic validation capabilities allow us to test translated instruments with native-speaking patients from the target population, ensuring comprehension and cultural suitability. We also integrate directly with your clinical team to align review workflows, streamline feedback cycles, and support protocol timelines.

Whether your study is in startup or preparing for regulatory submission, Sesen ensures your ePRO translations meet the highest standards of linguistic and clinical accuracy.

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Why Sponsors and CROs Choose Sesen

Sesen is not a generalist language provider. We specialize exclusively in life sciences, giving us a deep understanding of the clinical, regulatory, and linguistic nuances involved in global studies. Our expertise in ePRO translation and COA localization ensures that your patient-facing instruments are both accurate and compliant, supporting meaningful data collection and successful regulatory outcomes.

What Sets Us Apart:

We serve only the pharmaceutical, biotechnology, medical device, and digital health sectors, bringing domain-specific insight to every project.

Our team has supported hundreds of multilingual ePRO and clinical outcome assessment initiatives, including validated instruments and custom diaries.

All translations are performed by professional native speakers with training in clinical research terminology and global health authority standards.

We provide clear communication, real-time tracking, and full audit trails to ensure your project stays on schedule and meets all quality benchmarks.

With 150+ supported languages and 24/7 project coverage, we deliver consistent, scalable solutions across study phases and global sites.

Sesen combines linguistic precision with clinical insight, helping sponsors and CROs bring patient-centered innovations to market faster and with greater confidence.

Frequently Asked Questions (FAQs)

Sesen supports ePRO translation and linguistic validation in over 150 languages. We cover all major markets across North America, Europe, Asia-Pacific, Latin America, and the Middle East, using native linguists with clinical research expertise.

Yes. We collaborate closely with leading eCOA vendors such as Medidata, Clario, Veeva, and Signant Health to ensure smooth localization and technical integration. We deliver platform-ready files and validate formatting for accurate display and functionality.

We support licensing workflows and coordinate directly with instrument developers when required. Our team ensures that translations follow approved processes and that developer feedback is incorporated into the final deliverables.

We conduct in-country cognitive debriefing sessions with native-speaking patients to test clarity, comprehension, and cultural fit. Feedback is reviewed by our linguistic and clinical experts and used to refine the final version of the ePRO instrument.

Yes. Sesen provides full documentation for all ePRO translation and validation projects, including translation certificates, reconciliation reports, back translation summaries, cognitive debriefing results, and linguistic validation reports suitable for FDA, EMA, and PMDA submissions.

Related Services

Sesen provides end-to-end language solutions for all components of global clinical trials. Explore our related services to ensure linguistic consistency, regulatory compliance, and seamless patient communication across your study materials.

  • eCOA Translation Services

    Comprehensive localization of electronic Clinical Outcome Assessment platforms, including ePRO, ClinRO, ObsRO, and PerfO instruments across global trial sites.

  • eConsent Translation Services

    Professional translation of electronic informed consent forms with voiceovers, subtitles, and platform testing to support patient enrollment and regulatory review.

  • Linguistic Validation

    Full linguistic validation services following ISPOR guidelines, including dual forward translation, reconciliation, back translation, and cognitive debriefing.

  • Clinical Trial Translation Services

    Accurate translation of study protocols, IBs, CRFs, safety narratives, and other clinical documentation for submission and site use worldwide.

Sesen supports every phase of your clinical study with specialized language services tailored to life sciences.

Need Accurate ePRO Translation for Your Global Study?

Sesen provides specialized ePRO translation and linguistic validation services trusted by sponsors, CROs, and eCOA vendors worldwide. Whether you are localizing a validated instrument or launching a global Phase III trial, our team ensures linguistic precision, cultural appropriateness, and full regulatory alignment.

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