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Why Registry Entry Translation Matters

Clinical trial registries serve as a public record of research activity, improving transparency, accountability, and access to trial information worldwide. Platforms such as CTIS, EudraCT, ClinicalTrials.gov, and regional registries in Asia-Pacific and Latin America are often the first point of reference for regulators, investigators, and patients.

Accurate translation of registry entries is essential to meet the multilingual requirements of international regulatory authorities and ethics committees. It ensures that trial information is accessible to local stakeholders, supports compliance with country-specific mandates, and facilitates cross-border collaboration in multi-site trials.

In the European Union, the Clinical Trials Regulation (CTR) requires translated lay summaries and registry content in all member states where the trial is conducted. Similarly, registries in Japan, China, and several Latin American countries require content to be submitted in the local language as part of regulatory or ethical review.

Beyond compliance, multilingual registry translation supports global public health by making clinical research accessible to the communities it aims to serve. The World Health Organization’s Joint Statement on Public Disclosure of Results underscores the ethical obligation to make trial information available and understandable across languages. Sponsors that prioritize language accessibility not only reduce regulatory risk but also strengthen public trust in clinical research.

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What We Translate

Sesen provides accurate, regulatory-aligned translations of all key components required for clinical trial registry submissions. Our translations are tailored to meet the formatting and content requirements of major international registries, ensuring clarity, consistency, and compliance across languages.

We translate the following registry entry components:

Translation of both scientific and layperson summaries to support transparency and meet CTIS and national registry requirements.

Clear articulation of primary and secondary objectives to maintain consistency across multilingual submissions.

Precise translation of eligibility parameters for patient recruitment and regulatory clarity.

Localization of sponsor contact details, investigator names, and site addresses in compliance with registry standards.

Translation of study status, enrollment periods, and projected completion dates to keep stakeholders informed.

Accurate rendering of primary and secondary outcome assessments to maintain clinical integrity.

Localization of controlled vocabulary, dropdown options, and structured fields as required by platforms such as CTIS, ClinicalTrials.gov, and others.

All translations undergo rigorous QA to ensure accuracy, regulatory alignment, and consistency with prior submissions. Our workflows support structured data fields, XML formatting, and country-specific registry schemas.

Registries We Support

Sesen provides expert translation services for clinical trial registry entries submitted to major international and regional platforms. Our team is experienced in navigating registry-specific requirements, field structures, and language expectations to ensure regulatory compliance and public transparency across diverse geographies.

We support translations for the following registries:

Full translation support for CTIS submissions under the EU Clinical Trials Regulation, including layperson summaries and structured data fields across all EU languages.

Translation of legacy trial data entries and updates for compliance with EMA requirements and EudraCT public disclosure mandates.

Support for multilingual registry summaries when conducting global trials registered on the NIH platform, especially when collaborating with non-English sites.

Translation services for harmonized trial records across WHO-affiliated registries to support global transparency initiatives.

Japanese-language registry translation services aligned with PMDA and MHLW standards for local trial disclosure and ethics review.

Native Chinese translations of clinical trial registry content for NMPA and regional compliance, including Phase I through IV studies.

Multilingual support for post-marketing study registrations and safety follow-ups under EMA pharmacovigilance frameworks.

Translations tailored to local regulatory environments in countries such as Brazil, Argentina, Egypt, South Korea, and India, including support for language-specific submission portals.

Our services ensure that your trial entries are accurately localized, properly formatted, and aligned with evolving regulatory standards in each jurisdiction.

When Registry Entry Translation Is Required

Sesen supports a wide range of clinical trial sponsors and CROs in meeting the multilingual demands of global registry compliance. Our translation solutions are tailored to real-world scenarios where accuracy, speed, and regulatory alignment are critical.

Sponsors conducting multi-site studies in the European Union are required to submit translated registry content for each participating country. Sesen delivers compliant translations for CTIS entries, including lay summaries and structured fields in all EU languages.

Many regulatory frameworks, including EU CTR and WHO guidelines, mandate the publication of plain-language summaries for non-specialist audiences. We provide accurate, culturally appropriate translations to meet transparency and accessibility standards.

Early-phase studies conducted across Asian and European research centers require registry translations in Japanese, Korean, Mandarin, German, French, and other languages. Sesen ensures consistent, high-quality translations across all participating regions.

Adaptive trial designs require frequent registry updates due to protocol changes, interim results, or modified endpoints. Sesen offers scalable, fast-turnaround translation services to support these dynamic study designs without delay.

Our registry translation workflows are built to support compliance, accelerate timelines, and ensure your entries are understood by stakeholders across all trial locations.

Our Translation Process

Sesen delivers accurate and compliant registry entry translations through a proven workflow designed to meet the demands of global clinical research. Our process integrates regulatory precision, linguistic expertise, and quality assurance at every stage to support transparency and data integrity.

We begin by analyzing the source registry entry to confirm scope, language requirements, and submission format. Our team identifies registry-specific fields and ensures alignment with the study protocol and trial master file.

Each project is assigned to qualified, native-language medical translators with expertise in clinical research terminology and registry-specific standards. Translator selection is based on language pair, therapeutic area, and regulatory familiarity.

We leverage client-approved glossaries, Sesen’s internal termbase, and international standards such as MedDRA and WHO classifications to maintain consistency and regulatory accuracy across translations.

Our team ensures translations are formatted to meet the technical specifications of each registry platform, including support for structured data fields, XML schemas, and system-specific metadata in CTIS, EudraCT, and ClinicalTrials.gov.

All translations undergo a two-step quality review process, including a second linguist review and a final QA check by our in-house team. We validate completeness, linguistic precision, and regulatory alignment before final delivery.

For high-risk content or sponsor preference, we offer back translation and reconciliation workflows to further validate accuracy and confirm alignment with source meaning.

Sesen’s rigorous process ensures that every translated registry entry meets both regulatory expectations and public communication standards across all target languages.

Compliance-Driven Approach

Sesen operates with a strong focus on regulatory alignment to ensure your clinical trial registry entries meet the strict requirements of global health authorities. Our processes are built to support accuracy, traceability, and consistency across multilingual submissions.

Our translation services follow the guidance of leading regulatory frameworks, including the EU Clinical Trials Regulation (CTR), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the International Council for Harmonisation (ICH). We stay current with evolving requirements to support registry submissions across all major regions.

Sesen is certified to both ISO 17100 and ISO 9001:2015, ensuring standardized, auditable processes for translation quality and overall service delivery. These certifications reflect our commitment to consistency, risk mitigation, and continuous improvement in line with industry best practices.

Our team is familiar with platform-specific templates, controlled vocabularies, and field-level formatting used by registries such as CTIS, EudraCT, ClinicalTrials.gov, jRCT, and ChiCTR. We tailor our translations to match the structure and terminology conventions of each system.

We employ translation memory tools to maintain version control, improve turnaround times, and ensure linguistic consistency across multiple registry entries and trial phases. This approach supports efficient updates and minimizes redundancy in multi-country submissions.

With a compliance-first approach, Sesen acts as a reliable partner for sponsors and CROs navigating the complexities of global trial disclosure and registry management.

Technology-Driven Translation Accuracy

Sesen combines advanced language technology with regulatory expertise to deliver fast, consistent, and high-quality registry entry translations. Our tech-enabled workflows support structured data formats and ensure precise terminology alignment across multilingual submissions.

Our team is experienced in handling registry platforms that use structured field inputs, including CTIS and EudraCT. We work directly with XML and JSON formats to maintain data integrity and ensure compatibility with registry upload requirements.

SesenGPT, our proprietary large language model, supports dynamic terminology alignment by analyzing source content and suggesting context-specific translations based on regulatory, therapeutic, and linguistic datasets. This ensures consistent and accurate use of critical terms across registry entries.

We offer flexible integration with sponsor platforms, clinical trial management systems (CTMS), and registry submission tools to streamline workflows and reduce manual steps. Our secure file exchange and structured delivery options support version tracking and audit readiness.

By combining automation with human expertise, Sesen ensures your translated registry entries meet the highest standards of accuracy, speed, and regulatory precision.

Why Choose Sesen

Sesen is a trusted partner for sponsors and CROs managing multilingual clinical trial disclosures. Our specialized approach, regulatory knowledge, and scalable resources make us the preferred choice for accurate and compliant registry entry translation.

We specialize exclusively in life sciences, with deep experience translating registry entries, study protocols, and regulatory documentation in accordance with EMA, FDA, PMDA, and ICH standards.

Our global network of professional translators ensures native-language fluency and subject matter expertise for each target market, supporting global submissions with linguistic precision.

Sesen has delivered registry and trial support for some of the world’s largest pharmaceutical companies, consistently meeting quality, speed, and compliance expectations.

Whether you require a single-country submission or a high-volume multilingual rollout, our flexible resourcing model allows us to meet tight timelines without compromising quality.

Each project is overseen by a dedicated manager with experience in clinical trial workflows, regulatory compliance, and multilingual content delivery, ensuring seamless communication and execution.

Partnering with Sesen means working with a team that understands the regulatory landscape, respects the integrity of clinical data, and delivers consistently high-quality translations at global scale.

Related Services

Sesen provides a full suite of language solutions to support every stage of your clinical trial lifecycle. Explore these related services to ensure consistency, regulatory compliance, and high-quality multilingual communication across your clinical documentation and public disclosures:

  • Clinical Trial Translation Services

    End-to-end translation of clinical trial protocols, COAs, investigator brochures, and site-facing materials to support global trial execution.

  • Layperson Summary Translation Services

    Professional translation of plain-language summaries required for CTIS and other registries, ensuring accessibility for non-specialist audiences across all participating countries.

  • Linguistic Validation Services

    Complete linguistic validation workflows, including dual forward translation, reconciliation, back translation, and cognitive debriefing to support COAs, PROs, and eCOAs.

  • Back Translation Services

    High-quality back translation for critical trial content to confirm conceptual equivalence and meet sponsor or regulatory review requirements.

  • Informed Consent Form Translation

    Accurate and culturally appropriate ICF translations to support patient enrollment, ethics review, and regulatory compliance across diverse populations.

  • Regulatory Submission Translation

    Multilingual translation of CTD modules, cover letters, and correspondence for FDA, EMA, PMDA, and global health authority submissions.

These services work in concert to ensure your multilingual clinical trial materials are accurate, audit-ready, and fully aligned with international regulatory expectations.

Frequently Asked Questions

Under the EU Clinical Trials Regulation (CTR), sponsors are required to submit a summary of trial results in layperson language for each member state where the study is conducted. This summary must be translated into the official language(s) of each participating country and follow the structure defined by the European Medicines Agency (EMA). Sesen provides accurate and compliant lay summary translations aligned with CTIS formatting and EMA guidance.

Sesen uses translation memory tools and version-controlled glossaries to maintain consistency across registry updates and protocol amendments. Our linguists are trained to identify content changes and align new translations with previously approved language, ensuring clarity, accuracy, and regulatory alignment throughout the study lifecycle.

Yes. Sesen offers professional registry translation services in over 150 languages, including Japanese, Arabic, and Simplified and Traditional Chinese. We work with native medical translators who are experienced with local regulatory terminology and formatting requirements for platforms such as jRCT and ChiCTR.

Yes. We support translations for registry entries that require structured data input, including CTIS and EudraCT platforms. Our team handles XML and JSON files to maintain field-level formatting integrity and streamline submission workflows.

While not always required, back translation is sometimes requested for high-risk or high-visibility content, especially for layperson summaries and trial descriptions. Sesen offers optional back translation and reconciliation workflows for added quality assurance when needed by the sponsor or ethics committee.

Support Global Trial Transparency with Expert Registry Entry Translations

Ensure your clinical trial registry submissions meet regulatory standards, reach diverse audiences, and reflect your commitment to transparency. Sesen delivers accurate, multilingual translations tailored to the requirements of CTIS, ClinicalTrials.gov, EudraCT, and regional registries worldwide.

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