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Why Protocol Translations Matter

Clinical trial protocols are the foundational documents that define the study design, objectives, methodology, statistical considerations, and operational details. Accurate translation of these protocols is critical for ensuring that every site, regardless of location or language, executes the trial according to the same standardized procedures.

Protocol translations are a critical component of our broader Clinical Trial Translation Services that ensure regulatory compliance and site alignment across global studies.

Without precise and contextually accurate translations, multilingual trial sites risk misinterpreting inclusion criteria, treatment regimens, or safety reporting requirements. These discrepancies can lead to protocol deviations, patient safety issues, and compromised data integrity.

Global regulatory authorities such as the FDA, EMA, PMDA, and those adhering to ICH-GCP guidelines often require protocol translations for submissions, ethics committee reviews, and investigator training. Poor-quality translations can delay approvals or trigger compliance audits.

Sesen’s protocol translation services help sponsors and CROs eliminate these risks by delivering accurate, regulator-ready translations that ensure site compliance, uphold Good Clinical Practice, and maintain consistency across global operations.

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Our Protocol Translation Services Include

Sesen provides comprehensive protocol translation services designed to meet the complex linguistic and regulatory demands of global clinical trials. Our expert linguists and medical translators deliver accurate, consistent translations that support regulatory compliance and ensure site-level alignment across languages.

Our services include:

Precise translation of original and revised protocols for submission, IRB review, and site implementation.

  • Inclusion and exclusion criteria to ensure uniform patient screening across global sites
  • Study objectives and primary and secondary endpoints to support statistical alignment and clinical outcomes
  • Visit schedules and procedural descriptions for synchronized operational execution
  • Safety monitoring instructions and adverse event reporting protocols to protect patient well-being and meet regulatory expectations

Available when required by sponsors, ethics committees, or local authorities to verify translation accuracy and eliminate potential ambiguities.

Applied to patient-facing protocol components when required, ensuring clarity, cultural appropriateness, and conceptual equivalence across languages.

Our protocol translations are tailored to support rapid global deployment, protect data integrity, and maintain Good Clinical Practice at every trial site.

Regulatory-Compliant Protocol Translations

At Sesen, all protocol translations follow rigorous workflows designed to meet international regulatory standards and support global trial approvals. We ensure that every translated document is audit-ready, submission-compliant, and aligned with the latest regulatory expectations.

Our translation workflows are fully aligned with:

  • ICH E6 (R2) Good Clinical Practice, ensuring ethical and scientifically sound trial conduct across all languages
  • FDA and EMA protocol submission requirements, including formatting, terminology accuracy, and document integrity
  • PMDA guidelines for high-quality Japanese translations, supporting submissions for trials conducted in or including Japan

Our process includes secure and traceable translation workflows with full version control and documented audit trails. This enables transparent collaboration with sponsors, CROs, and regulatory teams throughout the study lifecycle.

We also support eCTD-compliant formatting for seamless integration into electronic submission platforms, reducing turnaround time and facilitating faster regulatory reviews.

With Sesen, you gain a trusted partner who understands the regulatory landscape and delivers translation solutions that stand up to scrutiny from global health authorities.

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Expert Linguists and Medical Review

Sesen’s protocol translation services are delivered by a highly specialized team of professional native linguists with deep experience in clinical research and regulatory documentation. Each translator is carefully selected based on subject matter expertise, language proficiency, and knowledge of Good Clinical Practice.

We assign linguists with proven therapeutic area expertise, including oncology, rare diseases, central nervous system disorders, cardiovascular studies, and more. This ensures that all clinical terms, study objectives, and safety instructions are translated with precision and contextual accuracy.

All protocol translations undergo medical review by certified MDs or PhDs fluent in the target languages. These reviewers validate scientific terminology, review critical sections for clinical accuracy, and ensure alignment with country-specific regulatory expectations.

To maintain consistency and accelerate turnaround, we apply internal quality control workflows, including:

  • Centralized translation memory systems to preserve terminology across projects
  • Client-specific glossaries for brand and regulatory alignment
  • Multi-step linguistic QA and final verification checks before delivery

Our team-driven approach ensures that every protocol translation meets the highest standards of linguistic accuracy, clinical relevance, and regulatory readiness.

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Global Languages and Regional Customization

Sesen delivers protocol translations in over 150 languages, supporting the multilingual demands of global clinical trials across North America, Europe, Asia-Pacific, Latin America, and the Middle East. Our large network of professional native linguists ensures high-quality translations tailored to both regulatory requirements and local clinical practices.

We specialize in region-specific language adaptations to ensure precise localization. This includes distinctions such as Canadian French versus European French, Brazilian Portuguese versus European Portuguese, and other country-specific variants that reflect cultural, medical, and regulatory nuances. These adaptations help reduce site-level confusion, enhance investigator compliance, and improve communication with ethics committees and regulators.

Our workflow is designed to support multi-country trials, including large-scale language rollouts that involve dozens of language pairs and versions. Whether your study spans three countries or thirty, Sesen coordinates seamless translation management with consistent terminology, centralized glossaries, and regionally appropriate content delivery.

By combining language expertise with localized insight, we help sponsors and CROs maintain protocol consistency across global trial sites while ensuring compliance with regional expectations.

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Workflow and Quality Assurance

Sesen applies a structured, quality-driven translation workflow tailored to the complexities of clinical protocol translation. Our processes are designed to ensure linguistic accuracy, regulatory compliance, and submission readiness, while offering the flexibility needed to meet diverse sponsor and CRO requirements.

We provide customizable workflows that accommodate client-specific needs, including internal stakeholder reviews, integration of IRB or ethics committee feedback, and document versioning throughout protocol amendments. These workflows are designed to ensure traceability, transparency, and full alignment across global teams.

Our team operates within a secure Translation Management System (TMS) that supports version control, centralized collaboration, and role-based access. This ensures data security and allows all stakeholders to monitor progress in real time.

Sesen is certified to both ISO 17100 for translation services and ISO 9001 for quality management, reflecting our commitment to excellence and operational consistency.

Every protocol translation undergoes a multistep QA process that includes:

  • Linguistic QA to ensure language accuracy, terminology consistency, and cultural relevance
  • Regulatory QA to verify compliance with ICH-GCP, FDA, EMA, and PMDA standards
  • Final formatting and layout checks to prepare documents for eCTD submission or IRB presentation

Our proven methodology ensures that each translation delivered is accurate, audit-ready, and aligned with both regulatory and clinical expectations.

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Human-Centric Translation Enhanced by Technology

Sesen combines advanced translation technology with subject matter expertise to deliver fast, accurate, and cost-effective protocol translations. Our human-centered approach is supported by intelligent tools that enhance consistency, accelerate timelines, and ensure compliance across global studies.

We leverage translation memory (TM) and termbase integration to maintain consistency across documents, reduce redundancy, and improve turnaround times. Each client’s approved terminology is stored and reused across protocol versions, amendments, and related documentation to ensure accuracy and regulatory alignment.

For high-volume or repetitive content, we offer hybrid translation workflows that combine secure, domain-specific machine translation with expert human post-editing. This approach increases efficiency while preserving the high quality required for clinical submissions and trial conduct documentation. Hybrid workflows are used selectively and only when appropriate for the document type and regulatory context.

Sesen also supports API and platform integrations with clinical trial management systems (CTMS), electronic trial master files (eTMF), and document review platforms. These integrations streamline file exchange, automate status updates, and facilitate real-time collaboration between sponsors, CROs, and translation teams.

By blending technology with human expertise, Sesen delivers protocol translations that meet the demands of modern clinical operations while upholding the highest standards of quality and compliance.

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Related Protocol Documents We Translate

In addition to full study protocols, Sesen provides expert translation of supporting regulatory and clinical trial documents to ensure consistency across your submission package and study operations. All translations are performed by qualified linguists with subject matter expertise and reviewed for compliance with global health authority standards.

We translate investigator brochures with a focus on clarity and regulatory accuracy, ensuring investigators understand the investigational product’s pharmacology, safety profile, and dosing guidance. Visit our Investigator Brochure Translation Servicespage to learn more.

Our team handles protocol amendments with speed and precision, maintaining version integrity and alignment with previous translations. Updates are carefully tracked and integrated into multilingual document sets.

Sesen provides accurate translation of paper and electronic CRFs to support high-quality data collection across global trial sites. We ensure consistency in terminology and layout to maintain data integrity throughout the clinical study. Visit our Case Report Form Translation Services page to learn more.

Sesen translates ICFs with linguistic and cultural sensitivity to ensure participant comprehension and regulatory compliance. Back-translation and ethics committee feedback integration are included when required. Learn more on our Informed Consent Form Translation page.

We deliver SAP translations with a focus on technical accuracy and statistical terminology consistency. Our expert reviewers ensure alignment with the protocol’s endpoints and analysis framework.

We translate submission materials for IRBs and ethics committees, including cover letters, response letters, and study summaries, ensuring clear communication and regulatory approval readiness.

Case Study or Testimonial

Our clients trust Sesen to deliver precise, regulator-ready protocol translations that support timely submissions, global site alignment, and successful trial execution. We collaborate closely with sponsors and CROs to manage multilingual documentation across complex clinical programs.

Client Testimonial

“Sesen ensured all protocol translations for our Phase III oncology trial were accurate, timely, and regulator-ready. Their team was knowledgeable, responsive, and detail-oriented. We relied on them to manage translations across 12 languages and they exceeded our expectations at every stage.”

— Clinical Operations Director, Global Biotech Sponsor

This testimonial reflects our commitment to clinical accuracy, regulatory alignment, and operational excellence in every translation project.

Ready to Translate Your Clinical Protocols with Confidence?

Work with Sesen to deliver protocol translations that are accurate, regulator-ready, and tailored to your therapeutic area. We help clinical teams ensure consistent execution across global sites while meeting the highest standards for quality and compliance. Explore our complete Clinical Trial Translation Services to support every phase of your study.

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