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Why Accurate Case Report Form (CRF) Translation Matters

Case Report Forms (CRFs), whether paper-based or electronic (eCRFs), are essential for standardized clinical data collection across multinational trial sites. Each data point recorded in a CRF contributes directly to study endpoints, regulatory evaluations, and clinical conclusions. Inaccurate or inconsistent translations can compromise data integrity, introduce variability across sites, and result in protocol deviations or costly regulatory delays.

Sesen’s CRF translation services ensure linguistic accuracy, scientific precision, and full regulatory alignment. By leveraging native-language clinical linguists and validated translation workflows, we help sponsors, CROs, and eClinical platforms maintain consistency across all trial geographies. Whether for Phase I–IV studies, observational trials, or post-marketing surveillance, accurate CRF translations are essential for upholding data reliability, patient safety, and global compliance.

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What We Translate

Sesen provides comprehensive translation support for all Case Report Form (CRF) materials required in global clinical studies:

Formatted and translated for accurate manual data collection across trial sites

Localized for leading EDC platforms, ensuring UI consistency and system compatibility

Translated with embedded instructions and metadata to support regulatory review and validation

Culturally adapted to capture patient-reported outcomes consistently

Translated for compliance with pharmacovigilance requirements

Clear, accurate translations to guide site staff and clinical teams in proper data entry and protocol adherence

Our CRF Translation Approach

Sesen follows a structured and compliant approach to Case Report Form (CRF) translation to support consistent data capture across multilingual clinical trials.

We align translations with the study protocol, therapeutic area, and sponsor-approved glossaries to ensure consistency across all CRF fields and patient-facing elements

Our process includes forward and back translation, reconciliation, and independent review when required by regulatory or sponsor standards

We support direct import and export of CRF content for platforms such as Medidata Rave, Veeva Vault, Oracle InForm, and TrialMaster, ensuring compatibility and efficiency

Local clinical reviewers assess translations for cultural relevance, medical accuracy, and regulatory fit within the target country

All translated CRFs undergo quality checks to verify terminology, formatting, and functional equivalence across all languages and layouts

Our CRF translations are fully aligned with study protocols and therapeutic objectives, supporting consistency across all related clinical trial translation services.

Compliance and Quality Standards

Sesen delivers Case Report Form (CRF) translation services that meet the highest standards for quality, consistency, and regulatory compliance in global clinical trials.

Our workflows are certified to ISO 17100 for translation services, ISO 9001:2015 for quality management systems, and ISO 13485:2016 for medical device quality assurance

We ensure all CRF translations align with the requirements of key regulatory authorities, including ICH-GCP, the US FDA, the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)

We tailor each project to the sponsor’s preferred terminology, formatting standards, and style guides, including CRO-developed templates and clinical SOPs

Every translation project includes documented approvals, version control, and reviewer feedback to support clinical audit readiness

Expert Clinical Linguists

Sesen’s CRF translation services are led by a global team of professional native-language linguists with deep expertise in clinical research and therapeutic-area terminology. Our linguists are carefully vetted for experience in translating complex clinical documents, including Case Report Forms, patient-facing content, and regulatory submissions.

Every CRF is translated by professionals fluent in the target language and experienced in clinical trial documentation. This ensures linguistic accuracy and contextual relevance for site personnel and patients.

For high-priority trials or complex therapeutic areas, translations are reviewed by native-speaking medical doctors or doctoral-level scientists to verify scientific accuracy and preserve clinical intent.

SMEs provide an added layer of validation to resolve ambiguities, clarify protocol-specific terminology, and align translations with therapeutic nuances across trial sites.

Our linguist model ensures CRF translations support accurate data collection, investigator comprehension, and global regulatory acceptance.

Smart Translation Workflows Powered by AI and Integration

Sesen combines advanced language technologies with domain expertise to streamline Case Report Form (CRF) translation while maintaining clinical accuracy and compliance.

SesenGPT accelerates the translation process by generating draft CRF translations using life sciences-trained AI models. These drafts are refined by professional clinical linguists to ensure accuracy, reducing turnaround times and project costs.

We leverage centralized glossaries and translation memory systems to maintain consistency across all CRF fields. This ensures alignment with sponsor-approved terms and supports scalable reuse across related clinical documentation.

Translated content is formatted for direct integration with leading electronic data capture systems including Medidata Rave, Veeva Vault, Oracle InForm, and TrialMaster. This compatibility streamlines workflows and minimizes manual formatting adjustments.

Our platform enables secure project management with version control, role-based permissions, and real-time collaboration. It supports full traceability and audit readiness while facilitating seamless communication among global stakeholders.

Multilingual Formatting and Layout Consistency

Accurate CRF translation is not only about the language. It also requires precise formatting and structural consistency across all localized versions to ensure clean data collection and usability at trial sites worldwide.

We maintain the structure, formatting, and field alignment of the original CRF in every target language. This helps clinical teams easily navigate translated forms without confusion or error.

Translations are formatted in strict accordance with sponsor or CRO-provided templates, as well as regulatory design conventions. This ensures that each CRF version is submission ready and consistent with global study documentation.

We work with all common CRF file types, including PDF, Excel, XLIFF, XML, and proprietary exports from EDC platforms. Our workflows support both static and dynamic layouts for print-ready and digital deployments.

This level of formatting precision ensures that every translated CRF remains functionally equivalent to the source, reducing site burden and improving cross-language data fidelity.

Key Benefits of Choosing Sesen

We provide CRF translation services in over 150 languages, covering major and emerging clinical research markets to support global study deployment.

Our translations are approved for use in regulatory submissions and clinical trials across North America, Europe, Asia-Pacific, Latin America, and the Middle East.

Every project is overseen by an experienced project manager who coordinates timelines, resources, and communication. Weekly status reports keep sponsors and CROs fully informed.

We offer scalable delivery timelines tailored to each project’s urgency, including expedited service for time-sensitive clinical milestones.

Our team has supported CRF translations for Phase I to Phase IV studies, observational trials, investigator-initiated research, and post-marketing surveillance programs.

Use Cases Across Life Sciences

Sesen provides Case Report Form (CRF) translation services tailored to the specific needs of life sciences sectors. Our expertise spans pharmaceutical, biotech, medical device, CRO, and eClinical environments, ensuring language accuracy, regulatory alignment, and seamless integration across all stages of clinical research.

We provide CRF translations to support global drug development programs across therapeutic areas such as oncology, immunology, cardiology, and infectious diseases. Our translations align with protocol objectives and are validated for regulatory compliance across trial regions.

Our team specializes in translating CRFs for complex and emerging biotech studies, including gene therapy, mRNA platforms, rare disease research, and cell-based therapies. We ensure terminology precision and scientific accuracy across all language pairs.

We translate device-specific CRFs and related documentation, accounting for product labeling, usability instructions, and post-market surveillance forms. Our process supports ISO 13485 compliance and ensures clear reporting across multilingual user environments.

Sesen supports CROs managing global trials with centralized translation workflows, language harmonization across countries, and responsive turnaround. We accommodate sponsor-specific templates and maintain consistency across multi-phase programs.

We provide CRF translation and localization services for integration into leading electronic data capture systems including Medidata Rave, Oracle InForm, Veeva Vault, and TrialMaster. Our team ensures accurate formatting, layout preservation, and efficient system compatibility across languages.

Frequently Asked Questions (FAQs)

Accurate CRF translation ensures that all clinical trial sites interpret questions and data fields uniformly across languages. This consistency minimizes site-to-site variation, reduces protocol deviations, and supports reliable, analyzable clinical data for regulatory submission.

Back translation is not always mandatory but is often recommended or required for certain trial types, jurisdictions, or therapeutic areas. It helps validate the accuracy of the forward translation and provides an added layer of quality assurance, particularly for critical data fields.

Paper CRF translation focuses on layout preservation and clear printed formats, while eCRF translation also considers software interface elements, character limitations, and system compatibility. Both require linguistic accuracy, but eCRFs often involve additional formatting and integration steps.

We use predefined templates, layout validation tools, and multi-format compatibility (PDF, Excel, XML, XLIFF) to preserve the original structure. Our linguists work in layout-aware environments, and final QA includes a formatting check to align translated versions with the source CRF.

Explore Related Life Sciences Translation Services

Sesen supports every stage of the clinical development lifecycle with specialized translation solutions tailored to regulatory, clinical, and patient-facing content. In addition to Case Report Form translations, we offer expert language services for the following critical study documents and workflows:

Ready to Streamline Your Multilingual CRF Workflows?

Ensure your global submissions are accurate, compliant, and delivered on time with Sesen’s expert regulatory translation services.

Whether you’re preparing an IND, MAA, IFU, or multilingual labeling, our team is ready to support your next milestone.

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