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What Is eConsent Translation?

Electronic informed consent, or eConsent, is the digital equivalent of traditional paper-based informed consent forms (ICFs) used in clinical trials. Delivered through web platforms, tablets, or mobile devices, eConsent enhances patient comprehension through interactive content, real-time access, and multimedia support. Unlike static paper forms, eConsent often includes features such as video explanations, voiceovers, interactive navigation, and digital signature capture.

eConsent translation refers to the process of localizing both the textual and multimedia elements of these electronic consent platforms into multiple languages. This includes translating the consent text, UI strings, voiceover scripts, and subtitles to ensure clear, culturally appropriate communication for patients across global regions.

Accurate electronic informed consent translation is essential to regulatory compliance and ethical trial conduct. It helps patients fully understand the study objectives, procedures, risks, and their rights, regardless of language or literacy level. Regulatory bodies and Institutional Review Boards (IRBs) require that multilingual patient consent materials be both linguistically accurate and functionally equivalent to the original.Accurate electronic informed consent translation is essential to regulatory compliance and ethical trial conduct. It helps patients fully understand the study objectives, procedures, risks, and their rights, regardless of language or literacy level. Regulatory bodies and Institutional Review Boards (IRBs) require that multilingual patient consent materials be both linguistically accurate and functionally equivalent to the original.

Sesen offers professional eConsent localization services for both text-based and multimedia formats. Our team translates video scripts, adds multilingual voiceovers, and provides localized subtitles to support patient understanding in decentralized and hybrid clinical trials. By combining linguistic expertise with regulatory knowledge, we help sponsors and CROs deliver compliant, patient-centric eConsent across more than 150 languages.

Sesen offers professional eConsent localization services for both text-based and multimedia formats. Our team translates video scripts, adds multilingual voiceovers, and provides localized subtitles to support patient understanding in decentralized and hybrid clinical trials. By combining linguistic expertise with regulatory knowledge, we help sponsors and CROs deliver compliant, patient-centric eConsent across more than 150 languages.

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Why Accurate eConsent Translation Matters

In today’s global clinical trial landscape, the use of electronic informed consent, or eConsent, is accelerating, particularly in decentralized and hybrid study models. Accurate eConsent translation plays a critical role in enabling informed decision-making, protecting patient rights, and ensuring ethical study conduct across diverse populations.

Effective eConsent localization ensures that patients fully understand the study objectives, procedures, potential risks, and their rights—regardless of their native language or literacy level. This is essential not only for ethical enrollment but also for maintaining regulatory compliance across regions.

Regulatory bodies including the FDA, EMA, and PMDA require that informed consent be properly translated and accessible to participants. Digital platforms must also comply with 21 CFR Part 11, GDPR, and ICH E6(R2) guidelines for electronic records, privacy, and Good Clinical Practice. Additionally, localized eConsent content must meet Institutional Review Board (IRB) and Ethics Committee (EC) standards for linguistic and cultural appropriateness.

Poor or incomplete translations can lead to misunderstanding, lack of patient engagement, and increased risk of protocol deviations or withdrawals. In contrast, well-executed multilingual patient consent improves participant comprehension, supports global recruitment, and reduces trial delays due to regulatory queries or consent-related issues.

By providing accurate, clear, and culturally adapted eConsent translations, Sesen helps sponsors and CROs build trust with participants and drive successful study execution in multilingual environments.

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Sesen’s eConsent Translation Capabilities

Sesen offers end-to-end eConsent translation services tailored to the needs of sponsors, CROs, and clinical technology providers. Our capabilities go beyond standard translation to support fully localized digital consent experiences that are compliant, culturally appropriate, and accessible across global trial sites.

Each service is designed to ensure patient comprehension and regulatory readiness across 150 languages.

We translate eConsent documents and patient-facing content with linguistic accuracy and clinical precision. Our professional native translators specialize in life sciences to ensure clear, compliant electronic informed consent translation for international regulatory submissions and IRB approvals.

Sesen localizes platform UI elements including buttons, labels, instructions, and navigation menus to provide a seamless experience for global users. We adapt digital consent workflows to maintain usability and consistency in each target language.

Our linguists adapt sensitive and nuanced consent language to reflect cultural norms, local healthcare practices, and region-specific regulatory expectations. Transcreation helps preserve meaning while respecting the emotional and ethical context for diverse populations.

We provide professional subtitle translation and voiceover production to support audiovisual eConsent modules. Our services cover timing, synchronization, and quality control to ensure accessibility and comprehension across all media types.

Sesen simplifies language and adjusts tone to accommodate participants with limited health literacy or educational backgrounds. We also translate age-appropriate content for pediatric studies, ensuring guardians and child participants clearly understand consent materials.

We translate audio narration scripts and coordinate with native voice talent to produce accurate and culturally appropriate recordings. This ensures consistency across audio and visual components of multilingual patient consent.

Our language experts work directly with your multimedia or eConsent platform teams to streamline localization workflows, reduce turnaround time, and optimize deployment of translated assets in platform-ready formats.

How Sesen Translates eConsent Forms

Sesen follows a structured and quality-driven workflow to deliver accurate, compliant, and platform-ready eConsent translation across 150 languages. Our process ensures that both textual and multimedia components are linguistically precise, culturally appropriate, and aligned with global regulatory requirements.

We begin by collecting all source materials, including electronic informed consent forms (ICFs), audio or video scripts, multimedia files, and eConsent platform interface elements. Our team reviews the content to assess translation scope, file formats, and platform integration requirements.

Professional native linguists with subject matter expertise in clinical research translate the consent materials. Where required, we perform forward and back translation to meet IRB and Ethics Committee expectations for linguistic validation. All content is reviewed for accuracy, clarity, and medical relevance.

Sesen localizes all audiovisual components of eConsent, including video subtitles, dubbing, and voiceovers. We synchronize translated scripts with visuals and audio tracks to deliver a seamless and engaging multilingual patient experience.

Our regulatory experts and in-country reviewers evaluate the translated content to ensure compliance with applicable standards, including 21 CFR Part 11, GDPR, ICH E6(R2), and local IRB/EC guidelines. We adapt language as needed to meet region-specific ethics and regulatory requirements.

We conduct quality assurance testing to confirm that all localized content is correctly displayed and functions as intended within the eConsent platform. This includes verifying character encoding, text expansion, multimedia timing, and user interface alignment in multiple languages.

Sesen delivers the fully translated and validated eConsent assets in platform-ready formats. We provide documentation to support regulatory submissions and can coordinate with your platform vendor or CRO for seamless implementation into digital workflows.

Platform Compatibility

Sesen delivers expert eConsent translation and localization services that integrate seamlessly with leading electronic consent platforms used in global clinical trials. Our team has hands-on experience working with both commercial eConsent solutions and custom-built platforms developed by sponsors or CROs.

We support localization of platform interfaces, patient-facing content, and multimedia elements, ensuring that translated eConsent materials are accurately rendered and fully functional across systems.

Supported eConsent Platforms Include:

We translate consent content and interface elements within the Medidata platform to support global trials with built-in regulatory compliance and patient engagement features.

Sesen provides end-to-end translation for SmartSignals-based studies, including script localization, multilingual voiceover, and UI adaptation to ensure regulatory and IRB readiness.

Our linguists work with Veeva’s clinical suite to deliver accurate, validated translations for patient-facing consent forms and interactive digital workflows.

We support REDCap eConsent deployments by translating embedded consent forms, platform instructions, and multimedia content across a wide range of study types.

Sesen translates video-based and interactive consent experiences built on ClinOne’s platform, enabling decentralized trials to engage patients globally with clear, localized content.

For proprietary eConsent systems, we collaborate closely with development teams to localize text strings, design layouts for multilingual support, and integrate multimedia translations directly into the digital environment.

Our flexible approach ensures that your multilingual patient consent workflows remain compliant, user-friendly, and ready for deployment in any clinical technology ecosystem.

Compliance and Quality Assurance

Sesen maintains the highest standards of quality and regulatory compliance to support accurate, reliable eConsent translation services for global clinical trials. Our workflows are designed to meet both international language quality standards and life sciences regulatory requirements, ensuring that multilingual patient consent materials are audit-ready and ethically sound.

Our operations are fully certified to ISO 17100 for translation services and ISO 9001:2015 for quality management. These certifications reflect our structured approach to quality control, risk mitigation, and continuous improvement across all project phases.

All translations are performed by native professional linguists with subject matter expertise in clinical research and medical terminology. Our translators understand the regulatory and ethical implications of informed consent and deliver content that is both accurate and culturally appropriate.

Every eConsent translation undergoes a rigorous, multi-phase quality assurance process that includes:

  • Forward translation
  • Independent review
  • Back translation (as needed)
  • Reconciliation
  • Final quality control checks

This structured workflow supports linguistic validation and ensures consistency across text-based and multimedia formats.

Sesen adheres to Good Clinical Practice (GCP) standards throughout the translation lifecycle. Our workflows are aligned with ICH E6(R2) guidelines and built to support IRB and Ethics Committee submissions globally.

Upon request, we provide detailed documentation and version history to support regulatory inspections or sponsor audits. Our systems track translator assignments, revision history, and QA steps to deliver full transparency and traceability.

By combining certified processes with life sciences specialization, Sesen delivers electronic informed consent translation services that meet the expectations of sponsors, CROs, regulators, and patients worldwide.

Use Cases Across Life Sciences

Sesen’s eConsent translation services are trusted by sponsors, CROs, and clinical technology providers across a broad range of therapeutic areas and study models. Our multilingual capabilities support regulatory compliance, patient engagement, and operational efficiency throughout the clinical development lifecycle.

We provide accurate eConsent translation for early-stage safety trials, large-scale efficacy studies, and post-marketing surveillance. Our workflows are adapted to meet the unique documentation and regulatory requirements of each clinical phase.

Sesen supports highly specialized trials that demand precise terminology and culturally sensitive content. Our linguists have expertise in complex therapeutic areas, including oncology, central nervous system disorders, rare genetic diseases, and vaccine development.

We translate age-appropriate consent materials for vulnerable populations, ensuring comprehension for both child participants and elderly patients. Our team simplifies language, adjusts tone, and accommodates caregiver consent workflows when required.

Sesen enables global participant enrollment by translating eConsent platforms for decentralized and hybrid clinical trials. We localize both textual and multimedia components to support remote onboarding and regulatory submissions across diverse regions.

We translate eConsent content embedded in mobile apps and digital health platforms used for remote monitoring, virtual visits, and continuous data collection. Our services ensure that patients can review and provide informed consent on any device in their native language.

By supporting a wide range of life sciences use cases, Sesen delivers electronic informed consent translation solutions that help accelerate global trial timelines while maintaining the highest standards of patient safety and data integrity.

Why Choose Sesen for eConsent Translation?

Sesen is a trusted partner for sponsors, CROs, and clinical technology providers seeking high-quality, compliant eConsent translation services. Our specialized expertise in life sciences, combined with advanced technology and personalized project management, ensures exceptional outcomes for global clinical trials.

Sesen specializes exclusively in life sciences translation. Every project is handled by linguists and regulatory experts with deep experience in clinical research. We do not outsource to generalists or unrelated sectors, ensuring precision and relevance across all content.

We provide electronic informed consent translation in over 150 languages. Our linguists deliver culturally adapted content that meets regional health literacy requirements and regulatory expectations. This ensures clarity, accuracy, and comprehension for participants across global study sites.

Our translation workflows are powered by SesenGPT, our proprietary AI solution for terminology consistency, speed, and real-time QA. SesenGPT supports scalable delivery without compromising quality, making it ideal for fast-paced or multi-country clinical trials.

We offer full localization support for video and audio-based eConsent, including voiceover, subtitling, and multimedia adaptation. Our team works with your production partners or eConsent platforms to deliver synchronized, patient-friendly digital consent experiences.

Each eConsent project is assigned a dedicated project manager who oversees timelines, quality control, and communication. We offer weekly status updates and can host review meetings as needed to keep stakeholders informed and aligned.

Sesen maintains strict data security protocols and complies with HIPAA, GDPR, and sponsor-specific data privacy standards. All projects are managed under NDAs, with secure file handling and audit-ready documentation available on request.

With a strong focus on regulatory compliance, linguistic precision, and operational transparency, Sesen delivers multilingual patient consent solutions that accelerate study startup and improve participant engagement worldwide.

Related Services

Sesen’s eConsent translation services are part of our broader suite of specialized language solutions for the life sciences. Explore the following related services to support every aspect of your multilingual clinical trial documentation and communication needs. These related services work together to deliver a fully integrated, compliant, and patient-centered language experience that supports your global clinical operations.

  • Informed Consent Form Translation Services

    Accurate translation of traditional ICFs to support paper-based or hybrid clinical trials. Our linguists ensure full comprehension and regulatory compliance across global study sites.

  • Linguistic Validation Services

    Comprehensive translation, back translation, and reconciliation services for patient-reported outcome instruments and consent materials, designed to meet IRB and Ethics Committee requirements.

  • Clinical Trial Translation Services

    Full-scale translation support for protocols, investigator brochures, case report forms, safety documentation, and regulatory submissions across all trial phases.

  • Multimedia Localization

    Professional localization of audiovisual content including subtitles, voiceovers, and user interface elements for digital health platforms, patient education, and eConsent modules.

  • Patient-Facing Materials Translation

    Translation of brochures, study guides, instructions for use, and other materials that help patients understand their role and responsibilities throughout the clinical trial.

Frequently Asked Questions (FAQs)

Sesen translates a wide range of eConsent content formats, including Microsoft Word documents, XML, JSON, and platform-specific interface files. We also support video scripts, audio narration, and multimedia assets used in electronic informed consent workflows.

Our multimedia localization process includes script translation by native-speaking linguists, followed by professional voiceover or subtitling by trained specialists. We conduct synchronization checks, terminology QA, and timing validation to ensure alignment between audio, visuals, and original content.

Yes. Sesen offers full back translation and reconciliation services to meet IRB, EC, and regulatory requirements. Our linguistic validation workflows follow best practices recommended by ISPOR and are aligned with ICH guidelines for informed consent documentation.

We provide digital QA and functional testing services to verify that translated content displays correctly and operates smoothly within the eConsent platform. This includes checking character encoding, interface rendering, multimedia timing, and user flow consistency across languages.

Need Reliable eConsent Translation for Your Global Study?

Accelerate patient enrollment and meet global compliance standards with Sesen’s expert eConsent translation services. We work with sponsors, CROs, and clinical technology providers to deliver linguistically accurate, culturally adapted, and platform-ready electronic consent materials in over 150 languages.

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