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What Are Decentralized Clinical Trials (DCTs)?

Decentralized Clinical Trials (DCTs) are clinical research studies that use digital health technologies to enable remote participation, reducing or eliminating the need for physical site visits. Unlike traditional models, DCTs rely on tools such as eConsent, telemedicine, wearable devices, and mobile health applications to collect data directly from patients in real-world settings.

This remote-first model supports a range of formats, including fully virtual clinical trials, site-less trials, and hybrid trials that combine in-person and remote components. The shift toward DCTs is driven by the rise of digital health platforms, the push for patient-centric trial designs, and the need to accelerate global enrollment while reducing geographic and logistical barriers.

As remote clinical studies become more prevalent, they require robust multilingual support to ensure regulatory compliance, patient comprehension, and consistent data quality across diverse global populations.

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Why Translation Matters in DCTs

As decentralized and hybrid clinical trials expand across regions, the volume and complexity of multilingual content continue to grow. DCTs rely heavily on digital interfaces and remote interactions, making accurate translation essential for every patient-facing touchpoint.

From eConsent platforms and mobile apps to wearable device instructions and telehealth communication, participants must receive information in their native language to ensure comprehension and informed participation. Regulatory authorities in many countries now mandate language access for electronic patient interactions, particularly for consent, safety reporting, and adherence-related communications.

Without professional translation, sponsors risk data loss, protocol deviations, and lower retention rates due to misunderstandings or noncompliance. Language localization directly influences the accuracy of patient-reported outcomes, the reliability of remote monitoring data, and the overall success of virtual clinical trials.

Translation is critical, not optional, for global DCT success.

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DCT Content Types We Translate

Decentralized clinical trials rely on a broad range of digital tools and patient-facing content that must be translated accurately and consistently across languages. Sesen provides professional translation and localization for the following DCT content types:

Interactive, multimedia, and layered consent forms that must be linguistically and culturally adapted to meet local regulatory requirements and support patient comprehension in remote settings.

Digitally administered clinical outcome assessments and patient-reported outcome tools requiring precise translation and linguistic validation to ensure data consistency across regions.

Mobile applications and web-based dashboards used by patients to report symptoms, manage tasks, and interact with study protocols. Sesen localizes UI strings and user flows to support multilingual engagement and usability.

On-device content, display instructions, and alerts for wearable health sensors and connected medical devices used in remote monitoring scenarios.

Standardized conversation scripts and pre-approved dialogue used during virtual study visits and remote patient interactions.

Automated voice prompts and SMS messages used for patient reminders, visit scheduling, and compliance tracking, localized for regional dialects and tone.

Voiceover, subtitling, and on-screen text translation for animated explainers, training clips, and how-to videos that guide patients and staff through digital trial procedures.

Culturally adapted brochures, digital ads, and landing pages developed to drive patient recruitment and maintain engagement throughout the study lifecycle.

Sesen translates clinical training modules, SOPs, and platform onboarding materials to support consistent implementation of DCT protocols across global trial sites.

Digital logs, alerts, and data dashboards used by CRAs and site monitors for oversight in remote or hybrid trial settings.

Regulatory Compliance and Linguistic Validation

Decentralized clinical trials must meet stringent regulatory requirements across multiple jurisdictions. Sesen supports global compliance by delivering high-quality translations that align with country-specific guidelines and institutional review board (IRB) or ethics committee (IEC) expectations.

Our team is experienced in adapting patient-facing and regulatory materials to comply with international standards, including those set by the FDA, EMA, MHRA, PMDA, and other health authorities. We offer language support for eConsent that reflects the legal and cultural requirements of each target country, helping sponsors secure IRB/IEC approvals more efficiently.

Sesen also provides full linguistic validation services for eCOA and ePRO instruments used in remote and hybrid trial models. Our process includes forward and back translation, reconciliation, cognitive debriefing, and documentation, ensuring conceptual equivalence and data consistency across languages.

We are certified to ISO 17100 for translation quality and ISO 13485 for medical device-related workflows, giving clients added confidence in our ability to meet regulatory and quality assurance standards for high-stakes multilingual content.

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Digital-First Localization Capabilities

Decentralized clinical trials rely on digital platforms to manage patient interactions, data collection, and real-time reporting. Sesen delivers specialized localization services designed for these technology-driven environments, ensuring global usability and regulatory alignment.

We translate software strings for mobile health applications, wearable interfaces, and patient portals used across virtual and hybrid trial models. Our team works directly with source files in XML, JSON, and FHIR-compliant formats to maintain structural integrity and accelerate implementation.

Sesen conducts functional UI and UX testing to verify that translated content renders correctly across languages, devices, and screen sizes. This ensures intuitive navigation, reduces user error, and enhances patient engagement in multilingual settings.

To streamline workflows, we integrate with client systems for secure content exchange, version control, and automation. Our team also supports API-based translation workflows that allow DCT platforms to scale efficiently while maintaining linguistic quality and consistency across regions.

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Global Reach with Local Insight

Sesen supports decentralized clinical trials across global markets with expert translation in more than 150 languages. Our professional native linguists are trained in life sciences and clinical research, ensuring accurate, culturally sensitive translations that align with local regulatory expectations.

We understand that language adaptation in clinical trials requires more than direct translation. Our team accounts for regional dialects, health literacy levels, and country-specific terminology to improve patient comprehension and protocol adherence across diverse populations.

Sesen maintains linguistic consistency through the use of client-approved glossaries, style guides, and reference materials tailored to each trial. These assets are developed collaboratively and applied across all translated content, from eConsent to remote monitoring.

We also offer proven experience in rare and regionally specific languages, supporting sponsors with recruitment and engagement in hard-to-reach populations while maintaining quality, accuracy, and compliance.

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Why Choose Sesen for DCT Translation?

Sesen specializes exclusively in life sciences translation, bringing unmatched subject matter expertise to every decentralized and hybrid clinical trial project. Our deep understanding of regulatory, operational, and linguistic challenges across trial phases allows us to deliver high-quality, compliant translations tailored to the unique demands of DCT models.

We have extensive experience supporting CROs, clinical trial sponsors, and DCT platform providers with multilingual content for eConsent, remote patient monitoring, eCOA, and other digital tools. Our teams are equipped to handle complex, high-volume projects with speed and precision.

Sesen offers agile turnaround times to meet the fast-paced rollout schedules common in remote and site-less trials. Each project is managed by a dedicated project manager who provides proactive communication and end-to-end coordination throughout the trial lifecycle.

To ensure accuracy at scale, we combine AI-powered quality assurance tools with rigorous human review. This hybrid approach enables consistency, reduces errors, and accelerates delivery across all supported languages and content formats.

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Client Success Story: Supporting Global Expansion of a Virtual Oncology Trial

A leading global CRO partnered with Sesen to support the multilingual rollout of a decentralized oncology trial spanning 12 countries across North America, Europe, and Asia. The trial relied on a fully remote model using digital consent, patient-facing mobile apps, and connected health devices to collect real-time data.

Sesen delivered translation and localization for interactive eConsent forms, mobile app UI strings, SMS notifications, and patient onboarding materials in 14 languages. Our team ensured regulatory alignment with country-specific ethics committees while maintaining consistency across content types.

The result was a seamless global launch with faster IRB approvals, improved patient comprehension, and high retention rates throughout the trial. The CRO continues to engage Sesen for ongoing DCT translation needs across other therapeutic areas and study phases.

Related Services

Decentralized trials require a wide range of multilingual content across digital and clinical workflows. Sesen offers complementary translation and localization services that support every component of your remote or hybrid clinical study.

  • eCOA Translation Services

    Specialized translation and linguistic validation for electronic clinical outcome assessments used in virtual and site-less trial models.

  • ePRO Translation Services

    End-to-end language services for patient-reported outcome instruments, including validated translations for mobile and web-based reporting tools.

  • Telehealth Localization

    Translation of patient-provider communication scripts, video consult interfaces, and remote care documentation to support global telemedicine integration in DCTs.

  • Clinical Study Documentation

    Accurate translation of protocols, informed consent forms, study manuals, and investigator brochures for global regulatory compliance.

  • Patient Diary Translation

    Language adaptation of digital and paper-based patient diaries used to collect real-time data in decentralized and hybrid trial environments.

  • App and Software Localization

    UI translation, in-context review, and multilingual QA testing for patient-facing platforms and investigator dashboards used in DCTs.

  • Multimedia Translation for Life Sciences

    Subtitling, voiceovers, and localized video content for training, onboarding, and patient education modules in multiple languages.

Ready to Support Your DCT Program Globally?

Sesen partners with sponsors, CROs, and DCT platform providers to deliver accurate, compliant translations for every phase of decentralized clinical trials. Whether you need multilingual eConsent, app localization, or global patient engagement support, our team is here to help.

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