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What Is a Clinical Study Report (CSR)?

A Clinical Study Report (CSR) is a comprehensive document that presents the methodology, results, and interpretation of a clinical trial. Prepared in accordance with the International Council for Harmonisation (ICH) E3 guidelines, the CSR serves as the primary scientific and regulatory record of a completed study.

The CSR includes detailed descriptions of study design, patient demographics, investigational product administration, statistical analysis methods, and key efficacy and safety outcomes. It also integrates supporting data from case report forms, listings, and appendices to provide full transparency of trial conduct and results.

Clinical Study Reports are essential for several critical functions:

  • Regulatory Submissions: CSRs are required by regulatory authorities such as the FDA, EMA, PMDA, NMPA, and Health Canada as part of marketing authorization applications and eCTD submissions.
  • Scientific Publications: CSRs serve as the foundation for peer-reviewed articles, conference abstracts, and clinical trial registries.
  • Internal Reference and R&D Use: Sponsors and CROs rely on CSR archives for future study design, comparative analysis, and internal evidence generation.

Accurate and complete CSR translation is vital when submitting to global health authorities or sharing results across international teams. Sesen supports these efforts with linguistically and scientifically aligned translation solutions across 150 languages.

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Why Accurate CSR Translation Matters

Clinical Study Reports play a central role in regulatory decision-making, making the accuracy of their translations critical. Health authorities such as the FDA, EMA, PMDA, and NMPA require CSRs to be translated with scientific precision and absolute clarity. Any ambiguity, inconsistency, or deviation from the source meaning can result in delayed approvals, additional queries, or outright rejection of the submission.

CSRs are often reviewed by multidisciplinary stakeholders including regulators, clinical reviewers, biostatisticians, ethics committees, and medical journal editors. These reviewers rely on translated documents to assess the integrity of trial data, evaluate risk-benefit profiles, and validate conclusions. Inaccurate or incomplete translations may compromise data interpretation or raise compliance concerns.

High-quality CSR translation requires not only subject matter expertise but also careful attention to formatting and structural fidelity. This includes accurate translation of tables, statistical outputs, footnotes, annexes, and cross-references. Regulatory bodies expect translations to retain the exact layout and terminology alignment found in the original document, particularly in submissions following the ICH E3 and eCTD standards.

Sesen’s CSR translation services are designed to meet these expectations through rigorous linguistic validation, regulatory-aligned workflows, and native-language experts trained in clinical and statistical content.

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Sesen’s Expertise in CSR Translation

Sesen specializes exclusively in life sciences translation, delivering Clinical Study Report (CSR) translations with the accuracy and compliance required for global clinical trial submissions. Our workflows are ISO 17100 and ISO 9001 certified, ensuring consistent quality, traceability, and regulatory alignment across every project.

All CSR translations are performed by native-language linguists with advanced degrees in fields such as medicine, pharmacology, biostatistics, and regulatory science. These translators are supported by specialized teams with deep domain knowledge across clinical development functions.

Our dedicated CSR teams include:

  • Medical Writers and Scientific Editors who ensure that translated content retains scientific rigor, consistent terminology, and contextual accuracy.
  • BIMO Compliance Experts who align translations with expectations set by FDA Bioresearch Monitoring inspections and Good Clinical Practice (GCP) requirements.
  • Annex and Data Table Specialists who handle complex appendices, listings, and statistical outputs with precise formatting and structure replication.

Sesen has a proven track record delivering high-quality CSR translations for pharmaceutical companies, biotech firms, and global CROs. Whether supporting a single-country submission or a multi-regional application, we provide scalable, compliant, and audit-ready translation solutions tailored to your regulatory and operational needs.

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Our CSR Translation Process

Sesen follows a structured, quality-driven process to ensure every Clinical Study Report (CSR) translation meets the highest standards of scientific accuracy, regulatory compliance, and linguistic consistency. Our approach is tailored for global health authority submissions and publication use.

We begin with a detailed review of the source CSR and its intended use. This includes an assessment of the document’s structure, volume, and regulatory jurisdiction. Our team identifies target languages, regional submission requirements, and any sponsor-specific style or terminology preferences to ensure alignment from the start.

To maintain consistency and regulatory compliance, we leverage sponsor-provided glossaries or develop custom glossaries and style guides as needed. These are aligned with ICH E3, MedDRA, and CTD module terminology standards. Terminology is validated to ensure harmonization across all sections, including narratives, statistical descriptions, and annexes.

Our native-language linguists have advanced academic and clinical backgrounds in therapeutic areas, medical writing, and regulatory affairs. They focus on preserving the scientific integrity and clinical nuance of the original content while adhering to regional regulatory expectations.

Each CSR translation undergoes a secondary review by senior translators and bilingual editors with experience in clinical research. This step includes verification of terminology, factual consistency, tone, and technical accuracy to meet regulatory and publication standards.

Sesen preserves the original layout of all tables, figures, and appendices to ensure structural fidelity. Our specialists handle complex annexes, statistical listings, and cross-references to maintain formatting integrity across all translated versions.

The final version undergoes a linguistic quality assurance review to ensure completeness, formatting consistency, and alignment with submission-ready formats. For regulatory applications, we can support formatting that meets eCTD Module 5 requirements, as well as bilingual output upon request.

CSR Translation for Global Regulatory Submissions

Sesen provides regulatory-grade Clinical Study Report (CSR) translation services to support global health authority submissions across all major regions. Our translation workflows are built around the specific requirements of each regulatory body to ensure submission readiness and audit compliance.

We translate CSRs in accordance with the expectations of:

  • FDA (United States): Supports New Drug Applications (NDAs), Biologics License Applications (BLAs), and FDA inspection readiness
  • EMA (European Union): Complies with Clinical Trial Regulation (EU CTR) and supports centralized and decentralized procedures
  • PMDA (Japan): Aligns with local submission practices and bilingual requirements for Japanese regulatory filings
  • NMPA (China): Ensures compatibility with Chinese regulatory formats and language-specific conventions
  • Health Canada: Supports Canadian Clinical Trial Applications (CTAs) and full regulatory dossiers
  • ANVISA (Brazil): Complies with language and format requirements for regulatory review and approval
  • TGA (Australia): Meets regional expectations for CSR content and language presentation

In addition to translating full study reports, Sesen offers multilingual submission support for related documentation, including:

  • eCTD Module 5 content: Translations aligned with the structure and terminology of the Common Technical Document, ensuring consistency across modules
  • Investigator Brochures (IBs): Scientifically accurate translations that support site selection, ethics review, and investigator onboarding
  • Safety Narratives: Patient-level summaries translated with clinical and regulatory accuracy for inclusion in safety submissions and aggregate reports

Our specialized knowledge of regional guidelines and submission formats allows sponsors and CROs to navigate complex global regulatory environments with confidence. Sesen ensures all translated documentation meets the linguistic, scientific, and formatting expectations of each health authority.

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Related Services

Sesen offers a full suite of clinical and regulatory translation services that complement Clinical Study Report (CSR) translation and support end-to-end submission readiness across global markets. Our integrated solutions ensure consistency across all critical study documents and regulatory modules.

Explore our related services:

  • Clinical Trial Protocol Translation: Translate study protocols with clinical precision and regulatory alignment to support ethics review, investigator training, and trial execution.
  • Investigator Brochure Translation: Provide multilingual IBs to ensure clear communication of study rationale, safety data, and investigational product profiles across global sites.
  • Case Report Form (CRF) Translation: Deliver accurate CRF translations that preserve data collection integrity and align with statistical analysis plans.
  • Patient Narrative Translation: Translate safety narratives for individual trial participants with medical accuracy to meet health authority expectations for adverse event reporting.
  • eCTD Submission Support: Ensure all translated documents meet formatting, structure, and terminology standards for electronic Common Technical Document submissions.
  • Regulatory Submission Translation: Translate full regulatory dossiers including Modules 2 through 5, ensuring compliance with ICH, FDA, EMA, and other global requirements.

These services are managed through centralized project oversight and quality systems, allowing Sesen to maintain consistency across document types and submission phases. By working with a single specialized partner, sponsors gain control, efficiency, and compliance throughout the clinical trial lifecycle.

Why Sesen?

Sesen is the trusted language partner for clinical and regulatory teams seeking accurate, submission-ready Clinical Study Report (CSR) translations. Our singular focus on life sciences ensures that every translation is handled with the scientific expertise, regulatory knowledge, and operational precision required for global compliance.

We combine linguistic accuracy with regulatory insight to help sponsors and CROs meet evolving submission standards across regions. Our clinical translation workflows are aligned with ICH, GCP, and eCTD requirements, providing confidence across all phases of clinical development.

Key advantages of working with Sesen:

Our teams are composed of native-language linguists with advanced degrees in medicine, pharmacology, and regulatory science. Every CSR is translated and reviewed by professionals who understand the therapeutic area, data structure, and submission purpose.

We are a trusted partner to leading biopharmaceutical companies, global CROs, and clinical operations teams across the industry. Our experience spans thousands of trial documents translated into more than 150 languages.

Whether translating a single CSR or supporting a large-scale, multi-region submission, Sesen offers the scalability and workflow automation to meet tight timelines and complex formatting requirements without compromising quality.

Our global teams operate across time zones to support around-the-clock project execution and client communication. This enables rapid turnaround and seamless collaboration with global stakeholders.

Sesen hosts its translation management system on Amazon Web Services (AWS), leveraging enterprise-grade encryption, role-based access controls, and continuous monitoring to protect client data and maintain confidentiality at all times.

By combining regulatory-grade translation capabilities with responsive service and secure delivery, Sesen provides a comprehensive solution for CSR translation and beyond. We help clients reduce risk, improve submission readiness, and accelerate timelines across international markets.

Frequently Asked Questions

The ICH E3 guideline defines the structure and content requirements for Clinical Study Reports submitted as part of regulatory applications. For translation, it ensures that CSRs follow a standardized format that includes sections such as study objectives, methodology, statistical analysis, efficacy and safety results, and appendices. Adhering to ICH E3 helps maintain consistency across languages and supports accurate regulatory review.

Yes. Sesen provides translation support for full CSRs as well as partial or interim reports, including ongoing safety updates, data cut-off reports, and investigator feedback summaries. These are often required during rolling submissions or periodic safety review cycles.

Absolutely. We replicate the structure and layout of tables, figures, footnotes, and appendices to match the source document. This includes complex statistical outputs, cross-referenced content, and section numbering, ensuring the translated CSR is submission-ready and consistent with formatting standards such as those used in eCTD Module 5.

Yes. Back translations and reconciled versions are available upon request, particularly for jurisdictions or study types that require verification of translation accuracy. This is commonly used for CSR excerpts included in patient-facing or ethics committee materials, or in highly regulated environments where linguistic validation is required.

Get in Touch

Ready to translate your Clinical Study Report for global submission? Contact Sesen to request a quote or schedule a free consultation with our clinical translation experts. We will review your requirements and provide a tailored solution aligned with regulatory and operational needs.

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