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Why Patient Diary Translation Matters

Patient diaries play a vital role in clinical trials by capturing real-time patient-reported outcomes (PROs), including symptom severity, treatment adherence, and quality-of-life indicators. These self-reported tools are essential for generating reliable efficacy and safety data, particularly in decentralized and patient-centric trial designs.

Accurate translation of patient diaries is critical to maintaining the scientific validity of trial endpoints across global study sites. Direct word-for-word translations often fail to reflect cultural nuances or region-specific expressions, which can lead to confusion, reduced compliance, and inconsistent data reporting.

Sesen combines linguistic precision with therapeutic area knowledge to deliver culturally adapted patient diary translations that preserve content meaning, support patient engagement, and align with regulatory expectations across regions. Our workflows help sponsors and CROs minimize protocol deviations, reduce site burden, and meet submission standards for FDA, EMA, and other health authorities.

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What We Translate

Sesen translates and localizes a comprehensive range of patient diary components used in clinical trials to capture self-reported health data. Our services support both paper-based and electronic formats, ensuring conceptual accuracy, cultural appropriateness, and usability across global study sites. Each deliverable is tailored to align with protocol requirements, therapeutic context, and regulatory guidelines.

Printed or handwritten diaries designed for patients to manually record symptoms, medication intake, and other health-related behaviors. These tools often require formatting preservation and linguistic clarity to maintain data accuracy and regulatory compliance.

Digital diary interfaces delivered via mobile apps, tablets, or web platforms. Our services include translation of UI strings, tooltips, dropdowns, and system messages, with careful attention to character limits and screen display constraints. Functional testing and in-context review can be provided in coordination with ePRO vendors.

Structured forms or scales used to monitor patient symptoms over time, such as nausea, fatigue, or joint pain. Translations ensure that terminology is medically precise while remaining accessible to lay users.

Patient-completed records that document drug names, dosages, administration times, and missed doses. Accurate translation supports medication adherence monitoring and protocol compliance in pharmacokinetic or safety studies.

Logs used to capture patient-reported physical activity levels, sleep patterns, and restfulness. These diaries are commonly used in CNS, metabolic, and oncology studies where lifestyle factors impact study outcomes.

Numerical or visual tools such as Likert scales, Faces Pain Scale, or Visual Analog Scale (VAS) that patients use to rate emotional or physical states. Translation requires both linguistic accuracy and alignment with culturally accepted expressions of pain or mood.

Text components that guide patients on how to complete their diaries correctly and consistently. These include introductory text, usage tips, frequency reminders, and motivational messages, which must be culturally adapted to maintain engagement.

All translations undergo linguistic review, proofreading, and formatting checks under our ISO 17100 and ISO 9001:2015 certified processes. We support delivery in client-specified formats and integrate with clinical trial systems to streamline multilingual diary deployment at scale.

Our End-to-End Translation Workflow

Sesen’s patient diary translation workflow is designed to ensure linguistic accuracy, regulatory compliance, and cultural relevance across all diary formats. Our ISO-certified process integrates linguistic expertise, therapeutic area knowledge, and technology compatibility to deliver high-quality, submission-ready translations for global clinical trials.

Our team reviews the source diary materials to assess content type, language requirements, therapeutic area, and target populations. We identify embedded terminology, character constraints (for ePRO), and formatting considerations to prepare files for translation and downstream processing.

When required, we conduct a harmonization step to align translated versions across multiple target languages. This ensures consistent interpretation of key concepts and facilitates downstream steps like cognitive debriefing. We follow ISPOR and FDA PRO guidance for validation methodology.

High-accuracy diaries may undergo forward translation into the target language, followed by independent back translation into the source language. Discrepancies are analyzed and resolved through a reconciliation process to confirm conceptual equivalence. This step is especially common for regulatory-facing trials or validated instruments.

Sesen can coordinate or support cognitive debriefing interviews with native-speaking patients to assess diary clarity, relevance, and cultural appropriateness. Results are analyzed and used to fine-tune the translations before finalization, ensuring high comprehension and usability in the target population.

All translations are proofread by a second linguist and undergo QA checks for terminology consistency, grammar, and adherence to diary-specific standards. We also apply regulatory formatting and prepare annotated versions for client or sponsor review.

For digital diaries, we translate all UI strings, system prompts, validation messages, and tooltips. We work closely with ePRO vendors or internal development teams to test translations in context, ensuring readability and interface compatibility on all platforms and screen sizes.

Finalized translations are formatted according to sponsor or CRO requirements. We deliver source files in print-ready, XML, XLIFF, or other structured formats as needed for integration into paper diaries, ePRO systems, or regulatory submission packages.

With Sesen, clients can submit multilingual content to health authorities with full confidence in regulatory compliance and linguistic integrity.

ISO-Certified Quality Assurance

Sesen delivers patient diary translation services under a robust quality management framework built to meet the stringent demands of global clinical research. Our processes are fully certified to international standards, providing sponsors and CROs with confidence in the reliability, consistency, and regulatory readiness of our work.

We are certified to the following standards:

Specifies core processes and quality requirements for professional translation. Ensures all patient diary translations are completed by qualified medical linguists and reviewed by independent experts.

Establishes a process-driven approach to quality control and continuous improvement. Supports risk management, standardized workflows, and client satisfaction across all language services.

Applies to projects involving investigational device trials or diary instruments used as part of a medical device study. Demonstrates our alignment with regulatory requirements for device-related documentation.

All translations undergo dual-review processes, terminology validation, and structured QA checks tailored to the needs of clinical diary instruments. Our ISO framework ensures that each deliverable meets not only linguistic accuracy, but also protocol alignment and health authority expectations.

Specialized Linguist Teams

Sesen’s patient diary translation services are led by dedicated teams of linguists who specialize in clinical research and patient-reported outcomes. Our linguists are selected based on subject matter expertise, language proficiency, and familiarity with regulatory and therapeutic requirements specific to global trials.

Key qualifications include:

All translators are native speakers of the target language with proven experience in clinical trial documentation. They understand the nuances of PRO terminology, plain language principles, and diary-specific phrasing required for patient comprehension.

We leverage local in-country reviewers to validate that each translation reflects culturally appropriate expressions, health beliefs, and patient behavior norms. This step is essential to improve usability and reduce patient burden across global populations.

Linguists are assigned based on experience in the relevant therapeutic domain, such as CNS, oncology, dermatology, or metabolic disorders. Their familiarity with clinical protocols, trial endpoints, and diary formats enhances the accuracy and consistency of translated content.

Our linguist network receives continuous training on evolving standards from FDA, EMA, MHRA, and ISPOR, including updates on linguistic validation best practices and requirements for ePRO and paper-based diaries.

By combining medical translation expertise with cultural insight and regulatory alignment, Sesen ensures that each diary supports accurate patient reporting, high compliance, and data integrity in multinational studies.

ePRO and Device Compatibility

Sesen provides expert translation support for electronic patient-reported outcomes (ePRO) across all digital platforms used in modern clinical trials. Our linguists and localization engineers work closely with sponsors, CROs, and eCOA vendors to ensure that all patient-facing content is accurately translated, contextually appropriate, and technically optimized for deployment on mobile, tablet, and web-based devices.

Our capabilities include:

Translation and localization of in-app diary content for smartphones and mobile platforms, including UI elements, error messages, and instructional text. We ensure linguistic clarity within the constraints of small-screen formats.

Support for larger display devices and responsive web applications used for remote patient data entry. We handle layout-specific adaptations to ensure optimal readability and functionality across device types.

Translation of structured text strings with careful attention to character restrictions, truncation risks, and text expansion in different languages. Our teams collaborate with development teams to preserve interface consistency and usability across locales.

We perform linguistic quality assurance in collaboration with software providers, conducting in-context reviews directly within the ePRO environment. This helps identify layout issues, misaligned translations, or formatting errors before final launch.

Sesen’s digital compatibility services support full localization lifecycle needs, from string extraction and translation to in-device testing and final validation, ensuring your ePRO diaries meet global deployment and compliance standards.

Linguistic Validation and Cognitive Debriefing

Sesen offers comprehensive linguistic validation and cognitive debriefing services to support the accurate translation and cultural adaptation of patient diaries used in global clinical trials. These services are essential for maintaining the integrity of patient-reported outcomes (PROs) and meeting regulatory expectations across regions.

Linguistic validation is typically required when a patient diary is used as a primary or secondary endpoint in a clinical trial, particularly for PRO instruments that are submitted to regulatory authorities. It is also necessary when adapting standardized, validated instruments across multiple languages and cultural contexts.

Sesen conducts or supports cognitive debriefing interviews with patients in the target population to assess comprehension, clarity, and cultural relevance of the translated diary. Feedback is analyzed and used to refine the translation to ensure it is easily understood and interpreted as intended by diverse patient groups. To learn more about Sesen’s cognitive debriefing services, please visit: https://www.sesen.com/cognitive-debriefing-services/.

Our approach follows established best practices from ISPOR (International Society for Pharmacoeconomics and Outcomes Research) and aligns with regulatory guidance from the FDA, EMA, and MHRA on the use of PRO instruments in clinical research. Documentation packages can be prepared to support health authority submissions and audit requirements.

All linguistic validation and cognitive debriefing work is performed by native-speaking linguists and local interviewers with subject matter expertise and therapeutic area experience. This ensures the diary retains conceptual equivalence and functional usability across all target markets.

Explore our full Linguistic Validation Services for more information.

Regulatory Compliance

Sesen delivers patient diary translations that meet the stringent regulatory requirements of global clinical trials. Our processes are designed to ensure linguistic accuracy, conceptual equivalence, and documentation readiness for regulatory submission in multiple regions.

Our approach follows the FDA’s Guidance for Industry on Patient-Reported Outcome Measures. We support the development of diaries that reliably measure patient input and contribute to primary or secondary trial endpoints. Translations are validated to preserve intent, clarity, and usability in line with FDA expectations.

We address the European Medicines Agency (EMA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) expectations regarding language adaptation of PRO tools. This includes cultural validation and documentation of cognitive debriefing, ensuring that translated diaries maintain data quality across EU and UK patient populations.

Our workflow is aligned with International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, ensuring that patient-facing materials are accurate, ethically sound, and suitable for use in clinical research across jurisdictions.

Sesen provides fully documented, submission-ready translations suitable for inclusion in the Common Technical Document (CTD). This includes source and target files, back translations if applicable, reconciliation reports, and linguistic validation summaries when required.

By combining regulatory expertise with specialized linguistic services, Sesen helps sponsors and CROs reduce risk, streamline approval processes, and maintain data integrity across multilingual clinical studies.

Global Language Coverage

Sesen provides patient diary translation services in over 150 languages, enabling sponsors and CROs to conduct multilingual clinical trials with confidence. Our global reach, combined with therapeutic and cultural expertise, ensures that patient-reported outcome (PRO) data remains consistent, reliable, and compliant across all regions.

Our linguistic network spans more than 150 languages, covering both widely spoken and less common languages used in emerging markets. This includes full support for rare dialects, minority languages, and region-specific variants required for precise localization in global studies.

Each multilingual study is supported by a dedicated project manager who oversees timeline coordination, file version control, and quality assurance across all target languages. Our teams are experienced in managing complex diary translation projects with multiple deliverables, stakeholders, and regulatory checkpoints.

We work with in-country linguists and reviewers across Asia, Europe, Latin America, and the Middle East and North Africa (MENA). These professionals ensure that diary content reflects local cultural norms, health literacy expectations, and regulatory preferences while maintaining medical accuracy and readability.

Whether your trial spans three countries or thirty, Sesen delivers scalable, high-quality translations that align with the linguistic, cultural, and regulatory needs of global patient populations.

Case Studies and Experience

Sesen brings deep experience in patient diary translation across a wide range of clinical trial phases and therapeutic areas. Our track record reflects consistent delivery of accurate, culturally adapted diaries that support global patient engagement and regulatory success.

We have translated and localized patient diaries for various clinical trials, including high-complexity studies in:

  • Central Nervous System (CNS) disorders, including epilepsy and neurodegenerative conditions
  • Oncology trials involving symptom tracking, pain reporting, and quality-of-life measures
  • Dermatology studies requiring detailed patient input on lesion progression and itch severity
  • Rare and orphan disease trials where patient feedback plays a central role in endpoint evaluation

Our portfolio includes multinational studies with diary deployment across more than 20 languages. In one project, we delivered validated diary translations for a Phase III oncology study spanning 18 countries within four weeks. In another, we supported a rare disease trial with simultaneous ePRO localization, cognitive debriefing coordination, and regulatory submission preparation.

“Sesen’s ability to manage multilingual diary translation with speed and precision has made them an essential partner for our international trial operations.”

— Clinical Operations Lead, Global CRO

For a detailed overview of our recent diary translation projects, please contact us to request anonymized case studies or speak with one of our clinical trial specialists.

Frequently Asked Questions

Yes. Sesen supports both paper-based and electronic patient-reported outcome (ePRO) diaries. We translate static diary documents as well as dynamic string-based content for mobile apps, tablets, and web platforms. Our team also performs in-context QA to ensure functional accuracy across all digital devices.

We customize each diary translation to meet country-specific linguistic, cultural, and regulatory requirements. Our in-country linguists adapt terminology, tone, and idiomatic expressions to align with local norms, improving patient comprehension and compliance. Regional variations are documented and version-controlled to support regulatory review.

Yes. We offer expedited services for urgent diary translation needs arising from mid-study protocol amendments or safety-related changes. Our global linguist network and scalable project management allow us to prioritize high-impact updates without compromising quality or compliance.

We deliver diary translations in a wide range of file formats, including Word, PDF, InDesign, XML, XLIFF, and platform-specific file types for ePRO systems. Formatting is preserved or adjusted as needed to match the original design, and we can also provide final print-ready or platform-ready outputs.

Back translation is not always required but may be necessary when the diary is a validated instrument or part of a regulatory submission. In such cases, we provide forward and back translation with reconciliation to confirm conceptual equivalence. We follow FDA, EMA, and ISPOR guidelines to determine when this step is appropriate.

Related Services

Sesen brings deep experience in patient diary translation across a wide range of clinical trial phases and therapeutic areas. Our track record reflects consistent delivery of accurate, culturally adapted diaries that support global patient engagement and regulatory success.

  • ePRO & eCOA Translation Services

    Accurate translation and localization of electronic clinical outcome assessments, including ePRO, ClinRO, ObsRO, and PerfO instruments across digital platforms.

  • Linguistic Validation Services

    End-to-end validation of translated PRO instruments to maintain conceptual equivalence and comply with FDA, EMA, and ISPOR standards.

  • Informed Consent Form Translation

    Translation of ICFs and re-consent materials to ensure patient understanding, legal clarity, and ethical compliance across all study sites.

  • Cognitive Debriefing Services

    Patient interviews conducted in the target language to test clarity, cultural relevance, and comprehension of translated diary content.

  • Translation Reconciliation Services

    Expert-led review and consolidation of forward and back translations to resolve discrepancies and produce harmonized final versions.

Each service is delivered with the same quality and compliance framework that underpins our patient diary translations. For end-to-end clinical trial language support, Sesen is your trusted partner.

Ensure Patient Diaries Are Accurate, Compliant, and Culturally Aligned

Work with Sesen to deliver expertly translated patient diaries that enhance global patient engagement, support endpoint reliability, and meet the latest regulatory standards. Our linguists, project managers, and QA teams are ready to support your next clinical study.

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