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Why Training Material Translations Matter in Clinical Trials

Accurate and culturally adapted training material translations are essential for successful global clinical trials. They ensure that all site personnel, regardless of language or location, receive consistent instructions and fully understand study procedures. Clear, multilingual training resources reduce the risk of misinterpretation, which can lead to protocol deviations, data inconsistencies, and regulatory noncompliance.

Regulatory agencies such as the FDA, EMA, and PMDA increasingly expect trial sponsors and CROs to provide localized training documentation to support global trial execution. This includes translated site initiation presentations, SOPs, eLearning content, and investigator manuals.

Effective translation of training materials also plays a critical role in demonstrating compliance with Good Clinical Practice (GCP) guidelines and staff qualification requirements during audits or inspections. It supports consistent knowledge transfer, enhances operational quality, and ultimately contributes to patient safety and reliable trial outcomes.

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Types of Training Materials We Translate

Sesen delivers precise, culturally appropriate translations for a full range of clinical trial training content. Our services support global site activation, protocol adherence, and consistent staff onboarding across multilingual regions. We work with leading sponsors, CROs, and training developers to translate the following materials:

  • Interactive learning content optimized for multilingual trial sites
  • SCORM-compliant modules, LMS-ready files, audio scripts, and on-screen text
  • Integrated translation of quizzes, assessments, and learner feedback forms
  • Site-level and sponsor SOPs related to study conduct, GCP compliance, and data management
  • Clear and accurate localization to prevent deviations and support audits
  • Harmonized terminology across trial documentation and operational manuals
  • Protocol-specific training documents, dosing guidelines, and visit procedures
  • Translations tailored to the medical and regulatory context of each country
  • Ensures that principal investigators and site staff receive consistent instructions
  • Translated PowerPoint materials for investigator meetings, site initiation visits (SIVs), and refresher trainings
  • Formatting preserved for seamless reuse in training sessions
  • Terminology aligned with protocol documents and clinical trial lexicons
  • Transcription, translation, subtitling, and voiceover services for clinical training videos
  • Localization of audiovisual content for digital delivery through LMS platforms
  • Professional narration using native-speaking voice talent with medical expertise
  • Pre- and post-training tests, compliance checklists, and evaluation forms
  • Localized content to support qualification tracking and regulatory readiness
  • Standardized translation workflows for reliable measurement of training outcomes

Key Features of Our Training Material Translation Services

Sesen delivers expert clinical trial training translations with a focus on linguistic precision, regulatory alignment, and operational efficiency. Our solutions are designed to support large-scale global studies across all phases and therapeutic areas.

We provide multilingual translations covering all major and emerging markets, enabling consistent training delivery across global investigator sites and regional study teams.

By leveraging translation memory (TM) tools and client-approved glossaries, we ensure consistent use of terminology across training modules, SOPs, and supporting documents. This accelerates timelines and reduces rework during updates or amendments.

Our quality assurance processes follow certified translation and management standards. Each project undergoes rigorous linguistic review, medical validation, and formatting QA to meet sponsor and regulatory expectations.

We go beyond literal translation to deliver content that is culturally and contextually appropriate for the target audience. This includes adapting idiomatic expressions, visuals, and instructional formats to improve comprehension and engagement.

Training materials are reviewed by qualified linguists with medical or clinical research backgrounds in the target market. This step helps validate terminology accuracy and ensures alignment with local regulatory norms and professional standards.

We use encrypted file transfer protocols and secure project management platforms to protect sensitive training content. Our version control processes support change tracking, compliance documentation, and structured updates over the trial lifecycle.

Human-Centered Translation with Advanced AI Support

Sesen combines advanced AI tools with the expertise of professional clinical linguists to deliver accurate, efficient, and contextually appropriate translations for training materials used in global clinical trials. Our approach balances automation with quality oversight to meet the strict demands of regulatory environments and multilingual study teams.

Our proprietary SesenGPT engine accelerates the translation process by pre-aligning terminology with existing glossaries, protocol documents, and regulatory references. This ensures faster delivery of training content while maintaining consistency across modules and documentation sets.

Every translation is reviewed by native-language professionals with clinical research experience. In-context validation ensures that the meaning, tone, and technical accuracy of each element are preserved, particularly for high-impact materials such as eLearning modules and investigator training manuals.

We support content formatted for all major eLearning and learning management systems, including Articulate, Adobe Captivate, Moodle, and others. This enables smooth deployment of translated modules across global sites without requiring additional technical rework.

Industries and Stakeholders We Support

Sesen works with a diverse range of organizations involved in the planning, execution, and oversight of clinical trials. Our specialized training material translation services are tailored to meet the unique requirements of each stakeholder group, supporting multilingual readiness and global trial scalability.

We support sponsors by translating investigator manuals, SOPs, and eLearning content that align with study protocols and therapeutic objectives. Our solutions help ensure global site teams are trained consistently, reducing risk and enhancing regulatory compliance.

CROs rely on Sesen to deliver accurate, culturally adapted training content for diverse study sites. Our scalable workflows and fast turnaround support complex, multi-country trials with variable timelines and documentation needs.

SMOs partner with us to translate training resources that standardize procedures across their investigator sites. Our services help ensure that clinical staff, coordinators, and monitors are aligned with sponsor expectations and GCP standards.

We collaborate with universities and academic medical centers conducting investigator-initiated trials. Our translations support ethics committee submissions, multilingual research team training, and consistent communication across international sites.

We work closely with instructional designers and training teams to localize SCORM-compliant modules, video tutorials, and assessments. Our integration with learning platforms ensures that translated content is functional, user-friendly, and compliant with global standards.

Training Material Localization Workflow

Sesen follows a structured and quality-driven workflow to deliver accurate, regulatory-compliant translations for clinical training materials. Each step is designed to ensure linguistic consistency, cultural relevance, and seamless integration with your learning platforms and training delivery systems.

We begin by reviewing the source files and confirming the project scope, target languages, and delivery requirements. Our team assesses technical specifications, content type, and regulatory expectations to define timelines and resource allocation.

Our linguists extract domain-specific terms and align them with sponsor-approved glossaries and therapeutic-area references. Terminology consistency across modules and documentation is critical for training clarity and compliance.

Content is translated by professional linguists who are native speakers of the target language and have clinical research expertise. Each translation undergoes rigorous quality assurance by medically trained reviewers to verify accuracy and contextual relevance.

We adapt translated content for eLearning modules, presentations, and training videos, maintaining visual integrity and formatting for compatibility with SCORM, HTML5, or print-based layouts.

Translated materials are submitted for client review and, if applicable, in-country validation by local teams. This step ensures cultural appropriateness, regulatory alignment, and approval by study stakeholders.

We deliver the finalized materials in the required output formats, ready for deployment through your learning management system or as printed documents for investigator meetings and on-site training.

Compliance and Quality Assurance

Sesen delivers clinical trial training translations that meet the highest standards of regulatory compliance and quality assurance. Our workflows are built to support sponsor audits, regulatory inspections, and internal quality controls while ensuring that all translated materials remain accurate, consistent, and inspection-ready.

All training material translations align with ICH-GCP guidelines and follow sponsor-specific standard operating procedures. This ensures that content meets global clinical research requirements and is fully acceptable for regulatory review.

We maintain a structured review process that incorporates feedback from client stakeholders and medical experts. Every revision is logged in an auditable trail, providing complete transparency and traceability from draft to final approval.

Our version control system supports seamless updates to training content in response to protocol amendments, regulatory changes, or sponsor-driven revisions. This ensures that all global trial sites receive updated, language-specific materials without delays or inconsistencies.

Case Study: Accelerating Site Readiness for a Multinational Oncology Trial

A leading global biopharmaceutical sponsor partnered with Sesen to translate and localize comprehensive training materials for a Phase III oncology trial spanning 22 countries. The project involved translating eLearning modules, SOPs, investigator manuals, and certification assessments into 18 target languages to support over 150 clinical sites.

  • Localization of SCORM-compliant eLearning content for oncology protocols
  • Translation of over 55 SOPs, study manuals, and site initiation slide decks
  • Voiceover and subtitle production for video-based procedural training
  • Compliance with ISO 17100, ICH-GCP, and sponsor-specific SOPs
  • Final deliverables formatted for direct upload to the sponsor’s LMS platform
  • Increased training completion rates by 30 percent within the first six weeks
  • Reduced protocol deviations related to procedural misunderstandings by 40 percent
  • Enabled simultaneous study start-up across North America, Europe, and Asia-Pacific

“Sesen delivered flawless multilingual training content under tight timelines. Their deep understanding of regulatory requirements and commitment to quality helped us launch our study faster and with full confidence in global site readiness.”

– Clinical Trial Project Manager, Global Oncology Sponsor

Explore Related Clinical Trial Translation Services

Our clinical trial training material translations are part of a fully integrated suite of language solutions that support every stage of your global study. From protocol development to patient consent, Sesen ensures consistent terminology, regulatory alignment, and linguistic accuracy across all trial documentation.

  • Investigator Brochure Translations
    Ensure clear communication of study objectives, investigational product details, and safety data with professionally translated investigator brochures reviewed by native-language MDs or PhDs.
  • Protocol Translations
    Translate complex clinical trial protocols with precision to support regulatory submissions, IRB/ethics approvals, and site adherence across multilingual trial regions.
  • Informed Consent Form (ICF) Translations
    Deliver patient-facing materials that are culturally sensitive, legally compliant, and easy to understand. Our ICF translations help ensure patient comprehension and informed enrollment worldwide.
  • eLearning Localization for Life Sciences
    Localize digital training and educational modules for clinical research personnel, patients, and healthcare providers. We support SCORM packages, multimedia content, and platform-ready formatting.

Ensure Global Site Teams Are Ready and Aligned

Accurate, culturally adapted training materials are essential for global trial success. Sesen delivers expert translations that support protocol adherence, regulatory compliance, and consistent site performance across regions.

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