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
global-patient-engagement-campaign

What You’ll Learn

This white paper provides actionable insights for sponsors, CROs, and digital health innovators navigating the evolving landscape of global clinical trials. Key takeaways include:

  • Why multilingual enablement is mission-critical for decentralized trials
    Understand how accurate, culturally adapted translations enhance patient recruitment, retention, and informed consent across geographies in remote and hybrid trial models.
  • Best practices for localizing eConsent, eCOA, and patient-facing materials
    Learn how to implement regulatory-compliant workflows for linguistic validation, cognitive debriefing, and UX-adapted patient content that supports diverse literacy levels.
  • How ISO 17100 and 9001-certified workflows ensure regulatory compliance
    See how certified translation processes and quality frameworks reduce audit risk and support documentation requirements across FDA, EMA, and PMDA submissions.
  • Strategic use of AI and MTPE for scalable clinical translation
    Discover when and how to apply machine translation with post-editing, and how Sesen’s hybrid workflows balance automation with human oversight for cost-effective, compliant delivery.
  • Real-world case studies from global trial deployments
    Explore examples of successful localization strategies for oncology, rare disease, and pediatric studies involving multilingual eConsent, mobile health apps, and caregiver instructions.
  • Emerging trends in multilingual innovation: biomarkers, chatbots, and SesenGPT
    Gain insight into the future of life sciences translation, including language-aware AI for dynamic patient communication, chatbot localization, and the role of linguistics in digital biomarker calibration.

Who Should Read This White Paper

This resource is designed for life sciences professionals involved in the planning, execution, and oversight of multilingual clinical trials. It offers strategic guidance for navigating the operational and regulatory complexities of decentralized and patient-centric study models.

  • Clinical operations leaders at pharmaceutical, biotech, and medtech companies seeking to optimize multilingual workflows and accelerate global trial timelines
  • Regulatory affairs professionals responsible for language compliance in submissions to agencies such as the FDA, EMA, PMDA, and other regional authorities
  • CRO teams managing global patient recruitment, informed consent, and digital engagement across diverse linguistic and cultural populations
  • Digital health and DCT platform innovators integrating mobile apps, wearable devices, and eSource systems that require localization and language QA
  • Translation and localization managers overseeing terminology consistency, linguistic validation, and ISO-compliant documentation for clinical programs

Key Topics Covered in the White Paper

This white paper explores the intersection of clinical trial localization, regulatory compliance, and emerging digital technologies. Key themes are organized into the following categories:

Decentralized Trial Language Needs

  • Multilingual enablement in decentralized clinical trials (DCTs)
    Explore how linguistic and cultural adaptation supports patient recruitment, retention, and informed consent in remote and hybrid trials.
  • UX localization, digital literacy, and inclusive design
    Learn how to tailor patient-facing materials for diverse literacy levels, visual preferences, and cultural norms to improve engagement and adherence.
  • Language coverage for wearables, mobile health apps, and digital diaries
    Understand how to localize user interfaces, notifications, onboarding flows, and symptom tracking tools to ensure consistency across platforms and devices.

Regulatory Compliance and Linguistic Validation

  • Global health authority expectations for translated content
    Review translation and validation requirements from the FDA, EMA, PMDA, and other regulators, with a focus on eConsent, eCOA, and patient materials.
  • End-to-end linguistic validation workflows
    Examine forward and back translation, reconciliation, cognitive debriefing, and documentation protocols for high-risk trial components.
  • Risk-based oversight for content categorization
    Learn how to prioritize validation and review levels based on content type, regulatory exposure, and study phase.
  • ISO-certified translation frameworks
    See how ISO 17100 and 9001 compliance ensures traceability, quality control, and audit readiness across the clinical trial lifecycle.

Translation Best Practices for Clinical Trials

  • Terminology harmonization across multilingual assets
    Discover the role of centralized glossaries and therapeutic-area style guides in maintaining clarity and regulatory consistency.
  • Integration with CTMS and eTMF platforms
    Learn how to embed translation workflows within trial management systems to streamline document version control and ensure regulatory alignment.
  • CRO-sponsor collaboration models
    Review best practices for aligning localization timelines, QA standards, and handoffs between trial stakeholders.
  • Quality assurance through in-country review and LQA
    Understand the role of native-speaking subject matter experts, linguistic QA scoring, and structured review cycles in safeguarding accuracy.

Technology and AI-Enhanced Translation

  • Translation Management Systems (TMS) and automation
    Learn how centralized platforms drive operational efficiency and full traceability across all translated study assets.
  • Selective use of MTPE (machine translation with post-editing)
    Identify appropriate use cases for MTPE and the controls needed to ensure regulatory-safe deployment.
  • AI-driven terminology and QA tools
    Explore how automated consistency checks, real-time QA scoring, and glossary validation tools reduce errors and accelerate review.
  • SesenGPT and hybrid translation models
    Understand how Sesen’s domain-trained AI supports clinical localization at scale while maintaining linguistic precision and compliance.

Innovation and Future Trends

  • Conversational AI and multilingual patient support
    Discover how localized chatbots and voice assistants are improving trial guidance, data collection, and engagement across global populations.
  • Personalized content delivery through adaptive AI
    Learn how AI-driven content routing enables tailored education and reminders based on region, language, and trial protocol.
  • Digital biomarkers and linguistic calibration
    Examine the role of language accuracy in mood inference, speech analytics, and behavioral data collection across languages.
  • Interoperable eSource localization
    See how multilingual content can be integrated directly into eSource and clinical data capture platforms while preserving data structure and GCP compliance.

Case Studies Inside

This white paper features real-world examples of how Sesen enables successful multilingual deployment in complex clinical trials. Each case illustrates the impact of language strategy, regulatory alignment, and technology-driven workflows in decentralized and patient-centric study environments.

  • Oncology DCT in 27 Languages
    In a global Phase III oncology study spanning 18 countries, Sesen supported end-to-end localization of eConsent modules, mobile app content, and eCOA instruments. By integrating translation workflows into the sponsor’s CTMS and eTMF systems and applying validated therapeutic glossaries, the team achieved a 40% reduction in turnaround time and zero language-related ethics review issues.
  • Rare Disease Pediatric Trial Localization
    For a rare disease DCT involving pediatric participants and caregivers across 12 countries, Sesen localized instructional videos, caregiver guidance, and digital diaries into 12 languages. The approach combined plain-language adaptation and in-country review to improve comprehension and drive measurable increases in caregiver-reported adherence and participant retention.
  • Global eConsent Compliance Enablement
    In a multinational cardiovascular trial, Sesen partnered with the sponsor to customize eConsent content to align with regional privacy regulations, legal norms, and cultural tone preferences. This tailored approach resulted in a 98% first-pass approval rate from local IRBs and significantly improved participant understanding scores in post-consent assessments.

Download the White Paper

Gain strategic insights into the future of clinical trial translation. This white paper provides practical guidance for optimizing multilingual workflows across decentralized, patient-centric, and digitally enabled studies. Learn how Sesen supports global sponsors and CROs with ISO-certified processes, regulatory-aligned localization, and AI-enhanced translation technologies.

DOWNLOAD THE WHITE PAPER DOWNLOAD THE WHITE PAPER

Access the full PDF by submitting your email address. Content is optimized for clinical operations, regulatory teams, and digital health innovators.

Additional Resources and Support

Looking to apply the insights from this white paper to your upcoming study? Explore related resources or connect directly with a member of our team

SCHEDULE A CONSULTATION SCHEDULE A CONSULTATION

Speak with a Sesen clinical language solutions expert about your trial’s multilingual strategy, regulatory requirements, or localization workflows.

Related Resources