Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.
Why Accurate Clinical Study Translation Matters
In today’s globalized clinical research environment, the accurate translation of clinical study documents is critical to the success and compliance of multinational trials. Regulatory bodies such as the FDA, EMA, PMDA, and other national health authorities require linguistically and technically precise translations to evaluate submissions and ensure patient protection.
Multilingual documentation supports global trial execution by enabling effective communication with diverse stakeholders—investigators, ethics committees, and, most importantly, patients. Poorly translated materials can result in regulatory delays, protocol deviations, or informed consent noncompliance, jeopardizing trial outcomes and sponsor reputation.
Accurate clinical trial translation ensures that:
- Study protocols are clearly understood across trial sites.
- Informed consent forms (ICFs) convey essential information to patients in culturally and linguistically appropriate ways.
- Safety reporting and regulatory submissions meet local language requirements and technical standards.
Whether submitting dossiers for approval or enrolling participants in non-English-speaking regions, precise and compliant translation of clinical study documents is fundamental for trial integrity, patient safety, and regulatory acceptance.
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Clinal Study Documents We Translate
Sesen provides specialized translation services for a wide range of clinical study documents to support global regulatory submissions, patient enrollment, and trial monitoring. Our linguists are trained in life sciences and regulatory terminology to ensure consistency, accuracy, and compliance with international standards.
Clinical Study Protocols
Precise translation of protocols ensures investigators across global sites consistently implement the study design, methodology, and procedures as approved by regulatory authorities.
Investigator’s Brochures (IBs)
We translate IBs with scientific accuracy to communicate product safety and efficacy data to clinical investigators, ethics committees, and regulatory agencies.
Case Report Forms (CRFs)
Accurate CRF translation is essential for uniform data collection and downstream statistical analysis, helping maintain data integrity across trial sites.
Clinical Study Reports (CSRs)
Our team delivers high-quality CSR translations that meet ICH E3 guidelines for regulatory submissions. We handle large volumes with precision and confidentiality.
Informed Consent Forms (ICFs)
We specialize in culturally adapted ICF translations, including back translation and reconciliation, to support patient understanding and regulatory compliance.
Patient Diaries & Questionnaires
Translations of PROs, diaries, and eCOAs are linguistically validated to maintain the reliability of patient-reported outcomes across languages.
Safety Reports (SAEs)
We provide expedited and accurate translations of serious adverse event (SAE) reports for timely submission to health authorities and ethics committees.
Monitoring Visit Reports
Translations ensure consistent documentation of site visits and compliance checks by clinical research associates (CRAs) across regions.
Ethics Committee Submissions
We translate IRB/IEC submissions in line with local regulatory and linguistic expectations to facilitate faster review and approval.
Trial Master File (TMF) Documents
TMF content, including correspondence, plans, and logs, is translated to support audit readiness and inspection compliance.
Other IRB/IEC Documents
Additional materials such as recruitment advertisements, re-consent forms, and participant letters are translated with attention to ethical and legal nuance.
Sesen combines subject matter expertise, linguistic accuracy, and regulatory knowledge to deliver trusted translations for every stage of the clinical trial lifecycle.
Translation Services for CROs, Sponsors & Life Sciences Companies
Sesen provides specialized clinical study document translation services tailored to the complex needs of life sciences organizations conducting trials worldwide. Our clients operate in highly regulated environments and require absolute precision, confidentiality, and speed. We support:
Contract Research Organizations (CROs)
We partner with global and regional CROs to streamline multilingual trial operations, from study startup to closeout. Our scalable solutions help CROs meet sponsor timelines and regulatory demands across diverse geographies.
Pharmaceutical Companies
From Phase I to post-marketing studies, we deliver high-quality translations that support investigational and commercial drug development, regulatory filings, and pharmacovigilance communications.
Biotech Firms
Biotechnology clients rely on Sesen for accurate and agile translation of scientific documentation to support breakthrough innovations and early-stage clinical development.
Medical Device Manufacturers
We translate documentation related to device trials, including usability studies, IFUs, and clinical evaluations, in compliance with MDR, IVDR, and FDA requirements.
Clinical Data Management Providers
We enable seamless data collection and analysis through consistent translation of eCRFs, data queries, and statistical programming documentation across languages.
Clinical Trial Sponsors
Sponsors trust Sesen to handle multilingual trial documentation for multi-country studies, ensuring clarity, compliance, and accelerated global reach.
Our Translation Process
Sesen follows a structured and quality-driven process designed specifically for clinical trial documentation. Our workflow combines regulatory expertise, linguistic precision, and advanced technology to deliver accurate, audit-ready translations that meet global compliance requirements.
Linguistic Validation & Back Translation
For patient-facing documents such as informed consent forms and questionnaires, we provide full linguistic validation and back translation to ensure conceptual equivalence, patient comprehension, and regulatory acceptance in all target markets.
Certified Translations with QA Checks
Every translation undergoes a multi-step quality assurance process, including bilingual review, in-country validation, and final certification for regulatory use. Our ISO-compliant workflows minimize errors and support submission-readiness.
Translation Memory & Glossary Management
We leverage translation memory (TM) and centralized terminology glossaries to maintain consistency across all trial documents, reduce turnaround times, and control costs—especially for multi-phase and multi-country studies.
Subject Matter Expert (SME) Review
All clinical content is reviewed by domain-specific linguists and medical subject matter experts to ensure accurate use of scientific terminology and alignment with therapeutic area standards.
Regulatory Alignment
Our processes adhere to Good Clinical Practice (GCP), ICH E6(R2), and ISO 17100 standards. We also support compliance with regional regulatory frameworks such as FDA, EMA, and PMDA language requirements.
TMF-Compliant Delivery Formats
We deliver translations in Trial Master File (TMF)-ready formats, ensuring traceability, version control, and audit-readiness for clinical trial sponsors and CROs.
Technology-Enabled Human Translation
Sesen provides specialized translation services for a wide range of clinical study documents to support global regulatory submissions, patient enrollment, and trial monitoring. Our linguists are trained in life sciences and regulatory terminology to ensure consistency, accuracy, and compliance with international standards.
SesenGPT for Terminology Management & Quality Assurance
We use SesenGPT, our proprietary AI engine, to enhance terminology extraction, style guide enforcement, and QA review—not for raw translation. This hybrid model enables faster project turnaround and higher linguistic consistency while keeping human expertise at the core.
Translation Memory for Consistency and Cost Efficiency
Our secure translation memory (TM) system reuses previously approved content to ensure terminological consistency across large trial programs. TM also accelerates delivery times and reduces translation costs for multi-country and multi-phase studies.
AWS-Hosted TMS with Version Control and Audit Trail
All projects are managed through a robust Translation Management System (TMS) hosted on Amazon Web Services (AWS), offering enterprise-grade security, version tracking, and a detailed audit trail for compliance with FDA 21 CFR Part 11 and other regulatory standards.
eTMF and CTMS Platform Integration
Sesen supports seamless integration with electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) platforms, enabling efficient content delivery, centralized document control, and improved oversight throughout the clinical trial lifecycle.
Compliance and Certifications
At Sesen, compliance is integral to every aspect of our clinical document translation process. We operate within a rigorous framework of international standards, ensuring our services meet the highest quality, regulatory, and data protection requirements across all markets.
ISO-Certified Quality Systems
Sesen is certified to the following globally recognized standards:
- ISO 17100 – Translation services quality and competence
- ISO 9001:2015 – Quality management systems
- ISO 13485:2016 – Quality systems specific to medical devices
These certifications reflect our commitment to process excellence, risk management, and continuous improvement in life sciences translation.
Regulatory Compliance
Our workflows are fully aligned with:
- ICH-GCP (International Council for Harmonisation – Good Clinical Practice)
- FDA 21 CFR Part 11 for electronic records and signatures
- EMA language requirements for clinical trial applications and product submissions
We translate clinical study documentation in accordance with these standards to support global regulatory submissions, audits, and inspections.
Data Privacy and Security
Sesen adheres to stringent data privacy protocols, including:
- GDPR (General Data Protection Regulation) compliance for the EU
- HIPAA (Health Insurance Portability and Accountability Act) compliance for the U.S.
All data is handled securely through encrypted channels and stored in our AWS-hosted infrastructure with access controls, audit trails, and confidentiality safeguards.
Global Reach with Local Expertise
Sesen supports multinational clinical trials with a global network of professional native medical translators who combine linguistic fluency with deep subject matter expertise. Our language solutions are tailored to meet the unique cultural, regulatory, and linguistic demands of each target market.
Professional Native Medical Translators in 150+ Languages
We work exclusively with professional, native linguists who are trained in medical and regulatory terminology. This ensures clinical study documents are not only technically accurate, but also contextually appropriate for investigators, patients, and regulatory authorities worldwide.
Localized Regulatory Knowledge
Our translators and reviewers bring region-specific regulatory insight, helping sponsors and CROs align with country-level requirements from ethics committees, IRBs, and national health authorities. We account for variations in terminology, formatting, and review preferences to support localized submissions and faster approvals.
Multilingual DTP for Patient-Facing Materials
We provide multilingual desktop publishing (DTP) services for materials such as informed consent forms, patient diaries, and recruitment brochures. Our DTP team ensures that translated content maintains formatting integrity, readability, and cultural relevance across all languages and file types.
By combining global linguistic coverage with local regulatory expertise, Sesen enables life sciences companies to confidently conduct clinical research in any geography.
Why Sesen?
Sesen is a trusted clinical study translation vendor specializing exclusively in life sciences. Our focused expertise, scalable operations, and regulatory know-how make us the preferred language services partner for top CROs, pharmaceutical sponsors, and biotech innovators.
Life Sciences Specialists Only
Unlike generalist agencies, Sesen serves life sciences exclusively, allowing us to build deep expertise in therapeutic areas, regulatory frameworks, and clinical documentation workflows.
Scalable Teams for Global Studies
We deploy scalable translation teams across 100+ languages to support high-volume, multi-country trials. Whether translating thousands of pages for a global Phase III study or rapidly localizing ICFs for a regional site activation, we adapt to your project scope and timelines.
Dedicated Clinical Project Managers
Each client is assigned a dedicated project manager with clinical trial experience who oversees every phase of the translation process, from kickoff to delivery. Our PMs ensure linguistic accuracy, regulatory alignment, and proactive communication.
Experience Across All Trial Phases
Sesen supports document translation for early-phase (I/II) studies, pivotal Phase III trials, and post-marketing safety and observational research. Our teams are trained to handle a wide range of clinical documentation with speed and precision.
Trusted by Top-10 CROs and Global Sponsors
We are proud to be a proven translation partner to several of the world’s leading CROs and life sciences companies. Our clients rely on us for consistent quality, compliance, and responsiveness across projects of all sizes.
Case Studies & Success Stories
Sesen has a proven track record of delivering high-quality clinical study document translation services that drive measurable impact for CROs, sponsors, and life sciences organizations conducting trials around the world. Our client outcomes demonstrate how expert language support contributes to regulatory success, operational efficiency, and faster trial execution.
Faster IRB Approvals Through High-Quality ICF Translations
A global CRO engaged Sesen to translate informed consent forms into 20+ languages across four continents. Our rapid turnaround, back translation workflows, and in-country validation helped reduce IRB review cycles by 30%, accelerating first-patient-in timelines.
Error Reduction and Consistency Across Multinational Phase III Trials
For a leading pharmaceutical sponsor, Sesen managed the translation of thousands of pages of clinical protocols, CRFs, and CSRs for a large-scale oncology study. By leveraging translation memory and centralized glossaries, we achieved a 99.8% QA pass rate and significantly reduced inconsistencies across regions.
Accelerated Country Startup for a Medical Device Study
In a high-priority device trial spanning Latin America and Southeast Asia, Sesen enabled site readiness within tight timelines by delivering fully formatted and linguistically validated documents ahead of schedule. Our integration with the sponsor’s eTMF system allowed seamless document tracking and regulatory submission.
What Our Clients Say
“Sesen has become our go-to language partner for clinical trials. Their turnaround times, regulatory familiarity, and attention to detail have helped us meet every milestone without compromise.”
— Senior Project Manager, Global CRO
“From early-phase protocols to CSR translations, Sesen consistently delivers quality and speed across all regions. We trust them for every high-stakes submission.”
— Director of Clinical Operations, Top-10 Pharma
Frequently Asked Questions
What is clinical study document translation?
Clinical study document translation involves the conversion of trial-related materials—such as protocols, informed consent forms (ICFs), and clinical study reports (CSRs)—into target languages to support global trial execution and regulatory compliance. These translations must be scientifically accurate, culturally appropriate, and aligned with regulatory standards across regions.
How do you ensure accuracy and compliance?
Sesen follows a validated translation process that includes professional native medical linguists, bilingual reviews, subject matter expert (SME) checks, and rigorous quality assurance. We are ISO 17100, ISO 9001:2015, and ISO 13485:2016 certified and adhere to ICH-GCP, FDA CFR Part 11, and EMA language requirements to ensure regulatory-compliant output.
Do you offer back translation for ICFs?
Yes. For patient-facing materials such as informed consent forms, we provide back translation and reconciliation to validate conceptual accuracy and meet IRB/ethics committee expectations. This is often required for submissions in the U.S., EU, Japan, and other regulated markets.
What languages do you support?
Sesen supports clinical translations in over 150 languages, including all major regulatory markets (e.g., EU, U.S., Japan, China, LATAM) and emerging regions. We work with professional native linguists who are fluent in medical and regulatory terminology specific to each target language.
Can you integrate with our eTMF or CTMS?
Yes. Our AWS-hosted Translation Management System (TMS) supports secure integration with eTMF and CTMS platforms, enabling streamlined file delivery, version control, and audit-ready documentation across the clinical trial lifecycle.
How do you handle urgent translations?
We offer expedited translation services for high-priority clinical documents. With scalable teams, global linguist coverage, and optimized workflows, we deliver rapid turnaround without compromising accuracy or compliance—ideal for safety reports, IRB responses, or startup materials under tight deadlines.