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Enabling Global Trial Readiness Through Multilingual Training
Accurate and timely training is essential for clinical trial success, particularly when studies span multiple countries, languages, and regulatory environments. Training materials such as investigator meeting slide decks, GCP training modules, standard operating procedures (SOPs), and site initiation resources must be clearly understood by all stakeholders to ensure protocol adherence and safeguard patient safety.
For global trials, the stakes are even higher. Miscommunication or misunderstanding of trial procedures due to poor translation can lead to protocol deviations, compliance risks, and delayed site activation. Yet translating training content is not as simple as converting text word-for-word, it requires deep knowledge of clinical terminology, regulatory expectations, and cultural context.
At Sesen, we specialize in translating clinical trial training materials with the precision required for investigator compliance and regulatory success. From multimedia eLearning modules to multilingual SOPs and ethics training, our linguists are life sciences experts who understand the demands of CROs, sponsors, and clinical training vendors. We help bridge the language gap so your global sites are ready, trained, and compliant from day one.
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Types of Clinical Trial Training Materials We Translate
Sesen translates a full range of training content to support global clinical trial operations, ensuring site personnel, investigators, and sponsors receive accurate and consistent information in their native language. Our services cover both document-based and multimedia training formats.
Investigator Brochures and Protocol Training Decks
Clear, multilingual presentation of study objectives, endpoints, eligibility criteria, and safety procedures to ensure alignment with the trial protocol.
Good Clinical Practice (GCP) Training Modules
Translation and localization of GCP content to support investigator certification, trial compliance, and adherence to ICH, FDA, EMA, and local regulations.
Standard Operating Procedures (SOPs)
Accurate translation of site and sponsor SOPs related to patient enrollment, informed consent, drug handling, AE/SAE reporting, and other trial-critical processes.
Site Initiation Visit (SIV) Presentations
Localized SIV materials to support site readiness, including roles and responsibilities, documentation requirements, and protocol-specific workflows.
Ethics and Regulatory Training Materials
Translations tailored to meet IRB/IEC expectations and country-specific ethics guidelines for participant protection and regulatory alignment.
eLearning Modules (SCORM, Articulate, Captivate, etc.)
End-to-end localization of interactive learning modules, including UI elements, embedded scripts, audio narration, and assessments.
Clinical Trial Management System (CTMS) User Guides
Technical translations for CTMS onboarding, including navigation instructions, data entry standards, and role-specific workflows.
Compliance Acknowledgment Forms
Multilingual translation of forms used to document training completion, protocol awareness, and regulatory compliance at the site level.
Multimedia Content: Voiceovers and Subtitles for Training Videos
Professional voiceover and subtitle services for video-based training, ensuring accessibility and comprehension across all trial sites.
Translation Services Tailored for Clinical Trial Training
Sesen delivers end-to-end language solutions specifically designed for clinical trial training content. Our services go beyond basic translation to ensure your materials are fully localized, compliant, and ready for global deployment.
Translation, Localization, and In-Context Review
We combine expert translation with cultural localization and context-aware linguistic review to ensure clinical accuracy and training effectiveness across all languages.
Terminology Alignment with Protocol and Trial Documents
Our linguists reference your protocol, investigator brochure, and regulatory documentation to ensure consistency in clinical terminology, reducing training risk and promoting protocol adherence.
Multilingual DTP and Layout for Training Decks
We provide professional desktop publishing (DTP) for multilingual PowerPoint, PDF, and InDesign training materials, preserving layout integrity across languages and character sets.
Voiceover and Subtitling for Audiovisual Content
Sesen offers high-quality voiceover and subtitle services for training videos, ensuring content accessibility and clarity for international investigators and site staff.
Linguistic Validation When Required
For training materials involving patient-facing instructions or behavioral assessments, we offer forward/back translation, reconciliation, and cognitive debriefing to support linguistic validation.
Regional Adaptation for Cultural and Regulatory Relevance
We adapt training materials for region-specific regulatory guidelines, site practices, and cultural expectations to maximize comprehension and compliance.
Workflow & Quality Assurance for Clinical Training Translation
Sesen follows a structured, ISO-certified workflow to ensure every translated clinical training material is accurate, consistent, and regulatory-compliant. Our process is built around quality, transparency, and collaboration.
Needs Assessment and Scoping
We begin each project with a detailed review of your training deliverables, study timeline, target languages, and compliance needs to define scope, formats, and delivery milestones.
Client Terminology and Training Objectives Review
Our team aligns with your protocol, trial-specific terminology, and instructional goals to maintain consistency across training modules, SOPs, and related materials.
ISO 17100 and ISO 9001:2015 Certified Process
Every translation project follows our certified workflows, with standardized procedures for linguist qualifications, version control, and risk management to meet regulatory expectations.
Professional Native Linguists with Clinical Training Expertise
We assign linguists with proven experience in clinical trial training content, ensuring accurate translation of scientific, procedural, and regulatory language.
Three-Step QA: Translation, Review, Final QC
Each file undergoes a rigorous three-stage process: initial translation, independent linguistic review, and final quality check for completeness, formatting, and linguistic integrity.
Optional Services: Back Translation, Reconciliation, In-Country Review
For high-stakes or patient-facing training content, we provide additional quality layers, including back translation, reconciliation, and validation by in-country experts as needed.
This robust workflow helps ensure training accuracy, investigator comprehension, and global site readiness, minimizing protocol deviations and regulatory risk.
Regulatory Compliance and CRO-Aligned Expertise
At Sesen, regulatory compliance is integrated into every aspect of our clinical trial training translation process. Our team understands the regulatory landscape and works seamlessly with CROs, sponsors, and training vendors to ensure that translated materials meet global standards and are inspection-ready.
GCP Compliance Awareness
All training content is translated with a clear understanding of Good Clinical Practice (GCP) guidelines to support investigator compliance and uphold participant safety across all study phases.
Global Regulatory Expertise
We are familiar with ICH E6(R2), FDA 21 CFR Part 11, EMA GCP directives, and local IRB/IEC requirements, ensuring your training materials are aligned with regional and international standards.
CRO, Sponsor, and Vendor Collaboration
Our workflows are designed to integrate with CRO operations, sponsor requirements, and third-party training platforms, delivering consistent, high-quality language solutions across stakeholders.
Inspection Readiness and Audit Support
We maintain full process documentation, version control, and audit trails to support regulatory inspections and ensure defensible compliance with SOPs and training protocols.
Secure, Compliant Infrastructure
All projects are managed through secure workflows hosted on AWS infrastructure, with data encryption and access controls that align with HIPAA, GDPR, and sponsor-specific security requirements.
Sesen is your trusted language partner for training translation that supports compliance, consistency, and global trial execution.
Seamless Technology Integration for Scalable Training Localization
Sesen leverages advanced tools and platform compatibility to streamline the translation of clinical trial training content. Our technology-enabled workflows ensure consistency, scalability, and ease of integration across your training ecosystem.
eLearning Platform Compatibility
We support full localization of interactive training modules built in Articulate Storyline, Rise, Adobe Captivate, and other SCORM-compliant authoring tools, preserving interactivity, functionality, and UI integrity.
eTMF and LMS System Integration
Our workflows align with electronic Trial Master File (eTMF) systems and Learning Management Systems (LMS), enabling smooth deployment, content tracking, and version-controlled updates across global sites.
Translation Memory and Termbase Management
Sesen maintains client-specific translation memory (TM) and terminology databases to ensure consistency across modules, reduce turnaround time, and optimize cost efficiency for recurring updates.
Multilingual Version Control and Update Support
We manage ongoing changes with structured version control across all language sets, ensuring synchronized updates to training content as protocols evolve or new regulatory guidance is issued.
With deep technical expertise and platform fluency, Sesen ensures your training materials are delivered in any language, ready for immediate use in your global clinical trial operations.
Use Cases and Success Stories
Sesen supports CROs and sponsors with high-impact training translation solutions across therapeutic areas and study phases. Below are real-world examples of how we enable global trial readiness through multilingual training:
Oncology Trial SOP and GCP Training
Delivered accurate translation of standard operating procedures and Good Clinical Practice modules into 6 languages for a multi-country oncology study across Asia and Europe.
Rare Disease eLearning Localization
Partnered with a global CRO to localize an interactive Articulate-based eLearning module for investigator training in a rare genetic disorder study, ensuring platform compatibility and regulatory alignment.
Multilingual SIV Training Videos
Provided voiceover and subtitling services in 12 languages for site initiation visit (SIV) videos on a compressed timeline, supporting rapid site activation across multiple regions.
Phase III Vaccine Trial Investigator Training
Translated and formatted training content for over 25 countries as part of a large-scale vaccine trial, supporting consistent investigator onboarding and protocol compliance worldwide.
These success stories reflect our ability to meet complex training requirements with speed, accuracy, and full regulatory awareness.
Frequently Asked Questions
Can you translate both documents and eLearning modules?
Yes. We translate a wide range of training materials, including static documents (SOPs, PDFs, PowerPoint decks) and interactive eLearning modules built in SCORM-compliant platforms such as Articulate Storyline, Rise, and Adobe Captivate. Our team ensures both content and user interface elements are accurately localized.
How do you handle updates to training materials mid-trial?
We maintain detailed translation memory and version control across all languages. When updates occur, we localize only the new or modified content, ensuring fast turnaround while preserving consistency with previously translated materials.
Do you offer multimedia translation services like voiceovers?
Yes. We provide professional voiceover and subtitling services for video-based training, including site initiation visit (SIV) recordings, GCP compliance videos, and investigator onboarding modules. Multilingual production is managed in alignment with your timelines and audio format requirements.
How do you ensure accuracy in complex scientific content?
All translations are performed by professional native linguists with clinical and regulatory expertise. We apply a three-step QA process—translation, review, and final QC—and refer to your protocol, study-specific glossary, and regulatory documentation to ensure scientific accuracy.
Can you align translations with our trial-specific terminology and protocol?
Absolutely. We build and maintain a custom termbase and reference your clinical protocol, investigator brochure, and prior study documentation to ensure alignment with your trial’s language, procedures, and compliance standards.
Trusted Partner for Clinical Training Translation
Sesen combines deep life sciences expertise with precision-driven language solutions to support global clinical trial training at scale. Our team understands the regulatory, operational, and linguistic demands of investigator education and site onboarding across international studies.
100% Life Sciences Focus
We specialize exclusively in translation for pharmaceutical, biotech, CRO, and medical device clients, with dedicated workflows for clinical and regulatory content.
ISO 17100, ISO 9001, and ISO 13485 Certified
Our certified quality systems ensure process transparency, linguistic accuracy, and full traceability—meeting the highest industry and regulatory standards.
In-House and Vetted Linguists with Clinical Expertise
We work only with experienced linguists who possess subject matter knowledge in clinical trials, GCP, and regulatory affairs, ensuring training content is translated with precision and context.
Familiarity with Training Rollout and Site Readiness Challenges
Our project managers are experienced in supporting site activation timelines, including protocol updates, urgent site initiation needs, and rapid document turnaround.
Scalable Team and Global Language Coverage
Whether translating content into 5 or 50 languages, our scalable linguist network and proven workflows ensure consistent quality and on-time delivery for multicenter trials.
AWS-Hosted Secure Infrastructure
All files and workflows are managed within an encrypted, access-controlled environment hosted on AWS. This setup supports full compliance with HIPAA, GDPR, and sponsor-specific data protection protocols, ensuring the confidentiality and integrity of sensitive clinical training materials.
