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What Is Multilingual Clinical Trial Enablement?

Multilingual clinical trial enablement refers to the strategic integration of language services into the planning and execution of global clinical trials. It ensures that critical trial content—such as informed consent forms (ICFs), study protocols, patient-facing materials, and site documentation—is accurately translated and culturally adapted for each target market.

Language accuracy, cultural relevance, and regulatory alignment are essential to patient safety, protocol adherence, and data integrity. Poor translations can result in delayed approvals, misinformed consent, and lower patient engagement, all of which increase the risk of trial failure.

Effective multilingual enablement supports faster site activation, more inclusive patient recruitment, and higher retention rates across diverse populations. As trials expand across regions, the ability to deliver clear, compliant, and culturally appropriate materials in multiple languages becomes a critical success factor.

Sesen’s multilingual clinical trial services are designed to reduce linguistic barriers, streamline global trial operations, and help sponsors and CROs achieve clinical and regulatory goals efficiently.

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Why Language Matters in Global Clinical Trials

As clinical trials continue to expand across borders, language becomes a critical operational and regulatory consideration. High-quality medical translation and localization directly impact trial success, from patient safety to regulatory timelines.

Accurate translation of informed consent forms (ICFs) ensures that patients fully understand study risks, procedures, and their rights in their native language. Misinterpretation at this stage can jeopardize patient safety and lead to noncompliance with Good Clinical Practice (GCP) guidelines.

Global regulatory bodies such as the EMA, FDA, PMDA, and Health Canada require localized documentation that adheres to strict linguistic and formatting standards. Errors in translation can result in rejected submissions, delayed approvals, and compliance risks.

Multilingual materials for investigator meetings, SOPs, and site initiation ensure consistent training and protocol adherence across regions. Properly localized site communications minimize variability and support reliable data collection.

Culturally adapted recruitment materials improve engagement across diverse populations, enabling more inclusive trials. Language access boosts enrollment rates and contributes to higher patient retention throughout the study lifecycle.

Delays caused by rework, clarification requests, or back-and-forth with regulators often stem from poor translations. A specialized, quality-assured language solution mitigates these risks, ensuring trial timelines stay on track.

Sesen’s multilingual clinical trial solutions are engineered to support compliant, consistent, and culturally appropriate execution of global clinical trials at scale.

Sesen’s Clinical Trial Translation Expertise

Sesen delivers high-precision clinical trial translation services backed by certified processes, therapeutic depth, and regulatory alignment. Our end-to-end solutions are built specifically for the life sciences sector to support global trial execution with confidence.

Every project follows stringent quality management protocols, ensuring linguistic accuracy, traceability, and full compliance with international translation standards.

Our translators and reviewers possess specialized knowledge across a range of therapeutic areas, including oncology, rare diseases, immunology, neurology, cardiology, and metabolic disorders. This enables terminology precision and contextual accuracy in complex trial documentation.

We work exclusively with native-speaking linguists who have clinical, regulatory, and medical backgrounds—ensuring translations are not only linguistically correct but also clinically and culturally relevant.

All content undergoes multi-step review, including translation, editing, proofreading (TEP), and, when required, back translation and reconciliation. We offer linguistic validation for patient-reported outcomes (PROs) and eCOA content.

Sesen assigns dedicated project managers with clinical operations and regulatory expertise. Our teams provide proactive communication, fast turnaround, and full oversight of multilingual trial deliverables.

Our proven track record in ISO-certified translation for life sciences and deep therapeutic area experience positions Sesen as a trusted partner for high-stakes global clinical trials.

What We Translate

Sesen provides comprehensive translation and localization support for both patient-facing materials and operational trial documents. Our services cover the full lifecycle of clinical trials, ensuring linguistic precision, regulatory compliance, and cultural relevance across global markets.

Clear, culturally adapted communication is critical to ethical trial participation and patient engagement. We translate:

  • Informed Consent Forms (ICFs) – Including certified translations, back translation, and reconciliation for regulatory compliance
  • Assent Forms – Tailored for pediatric or cognitively impaired populations
  • Recruitment Flyers and Digital Ads – Optimized for local audiences to support multilingual patient recruitment
  • Patient Diaries, PROs, and eCOA Content – Ensuring accuracy in symptom tracking and patient-reported outcomes across devices and languages
  • Post-Trial Communications – Including end-of-study letters and follow-up materials for continued patient support

We ensure that clinical sites and investigators receive accurate, fully localized documentation to enable protocol adherence and consistent trial execution:

  • Protocols and Amendments – Expertly translated with attention to regulatory and scientific terminology
  • Investigator Brochures – Supporting global site engagement and training
  • Site Training Materials – Including SOPs, manuals, and presentation content
  • Case Report Forms (CRFs) – Aligned with data collection standards and EDC systems
  • Study Start-Up Documentation – Including ethics committee submissions and site initiation packs
  • Safety Narratives & SAE Reports – Translated with precision to support pharmacovigilance and adverse event reporting

Each document type is handled by our professional linguists with subject matter expertise and supported by our rigorous QA processes to ensure readiness for submission, review, or patient use.

Our Multilingual Workflow for Clinical Trials

Sesen’s clinical trial translation workflow is designed to deliver accuracy, consistency, and regulatory compliance across all languages. Our process aligns with best practices for multilingual clinical trial execution, ensuring quality from intake to final delivery.

Each project begins with a detailed analysis of the trial’s linguistic, regulatory, and therapeutic requirements. We assess target languages, submission timelines, country-specific regulations, and documentation scope to build a tailored workflow.

We assign native-speaking linguists with subject matter expertise in the relevant therapeutic area. All linguists have clinical and regulatory experience to ensure proper terminology usage and contextual accuracy.

Documents undergo a structured, three-step linguistic process:

  • Translation by a qualified medical translator
  • Editing by a second linguist to verify terminology, tone, and clarity
  • Proofreading to finalize grammar, formatting, and consistency

For patient-facing materials, we conduct optional in-country review by local clinical teams or perform full linguistic validation—including cognitive debriefing—for PROs and eCOA content, in line with regulatory requirements.

We prepare documents for submission or distribution by applying multilingual formatting standards. Our DTP team works with clinical layouts (PDF, InDesign, XML, etc.) while preserving the original design and compliance requirements.

All files undergo a final quality assurance check to confirm linguistic accuracy, formatting integrity, and regulatory readiness. Deliverables are provided in validated formats (e.g., PDF/A, XML, DOCX), ready for ethics committees, regulatory submission, or trial use.

This proven process ensures a smooth, scalable, and audit-ready multilingual clinical trial experience.

Technology-Enabled, Human-Expert Solutions

Sesen combines cutting-edge translation technologies with specialized human expertise to deliver high-quality, scalable multilingual solutions for clinical trials. Our hybrid approach enhances speed, consistency, and data security while maintaining the clinical and regulatory precision required in life sciences.

We leverage an advanced TMS that centralizes workflows, enforces terminology consistency, and improves turnaround times. Integrated terminology databasesand translation memory (TM) tools ensure reuse of validated content across trial phases and languages, reducing both costs and regulatory risk.

For high-volume, low-risk materials—such as recruitment outreach or internal training content—we offer Machine Translation Post-Editing (MTPE) performed by qualified linguists with medical experience. This approach ensures faster delivery without compromising accuracy where full human translation may not be necessary.

All translation activities are conducted on a secure, HIPAA-compliant infrastructure hosted on Amazon Web Services (AWS). We apply enterprise-grade encryption, access control, and audit logging to meet the strictest data privacy and security standards required for clinical documentation.

Sesen supports seamless integration with eTMF systems, clinical trial management platforms (CTMS), and sponsor portals. This enables efficient document exchange, version control, and automated updates across trial documentation workflows.

Our technology-driven yet human-led model ensures translation efficiency while upholding the regulatory rigor and linguistic accuracy essential to clinical research.

Regulatory & Compliance Alignment

Sesen’s multilingual clinical trial services are fully aligned with global regulatory requirements, ensuring that all translated materials meet the highest standards for accuracy, traceability, and submission readiness. Our processes are designed to support audit-ready documentation across all trial phases and regions.

We ensure alignment with the specific language, formatting, and documentation standards mandated by leading regulatory bodies, including:

  • EMA (European Medicines Agency)
  • FDA (U.S. Food and Drug Administration)
  • PMDA (Japan)
  • Health Canada
  • MHRA (UK)

Our teams stay current with evolving regional guidelines to support cross-border clinical trial approvals and regulatory submissions.

Sesen provides expert localization for multilingual trials across Europe, North America, Asia-Pacific, LATAM, and MENA. We address country-specific language mandates—for example, French in Quebec or Japanese in local PMDA submissions—ensuring each document complies with jurisdictional expectations.

For informed consent forms (ICFs), we offer certified translations, back translation, and reconciliation services in accordance with EMA and FDA expectations. These services ensure accuracy and comprehension while supporting ethics committee and IRB approvals.

All projects follow traceable, ISO-certified workflows with version control, change tracking, and documented QA procedures. Our deliverables are submission-ready and designed to meet sponsor, CRO, and regulatory audit requirements.

Sesen enables sponsors and CROs to confidently manage regulatory risk and streamline approvals through high-quality, compliant multilingual clinical trial documentation.

Why Sponsors and CROs Choose Sesen

Leading pharmaceutical companies, biotechs, and contract research organizations (CROs) rely on Sesen for precision, speed, and regulatory confidence in multilingual clinical trial execution. Our specialized approach, dedicated teams, and proven performance make us a trusted language partner in complex, global studies.

Sesen is exclusively dedicated to life sciences translation and localization. This focus ensures deep domain expertise, consistent terminology, and full alignment with clinical, regulatory, and scientific standards.

Our agile teams scale to meet client demands and rapidly adapt to protocol changes, tight submission deadlines, and evolving regulatory timelines—without compromising quality.

We provide transparent communication through weekly progress reports, real-time issue tracking, and on-demand performance metrics, helping sponsors and CROs maintain full visibility across multilingual deliverables.

Each engagement is led by a senior project manager with hands-on experience in clinical trials and regulatory processes. This ensures proactive planning, effective risk mitigation, and seamless collaboration with sponsor or CRO teams.

Sesen has supported multilingual clinical trials for some of the world’s leading life sciences organizations. Our track record spans therapeutic areas and trial phases, including Phase I–IV studies, post-marketing surveillance, and patient registries.

With a foundation in regulatory precision, clinical expertise, and global scalability, Sesen delivers trusted clinical trial translation services that meet the rigorous demands of today’s global research landscape.

How Sesen Enabled a 12-Country Oncology Trial with Multilingual ICFs in 3 Weeks

A global biopharmaceutical sponsor engaged Sesen to support a time-critical oncology trial requiring rapid deployment of informed consent forms (ICFs) across 12 countries and 15 languages.

The sponsor faced regulatory deadlines for ethics committee submissions across multiple jurisdictions. Each country required localized ICFs that met both linguistic and regulatory standards, including back translation and reconciliation for IRB compliance. The timeline: 3 weeks from project kickoff to final delivery.

Sesen deployed a dedicated multilingual clinical trial team, including:

  • Native-speaking medical translators with oncology and regulatory expertise
  • A centralized TMS with translation memory and terminology management
  • Coordinated back translation workflows in parallel with ICF adaptation
  • ISO 17100–certified quality assurance, including linguistic validation
  • Seamless delivery of audit-ready files in country-specific formats (PDF/A, XML)
  • Delivered 100% of translations within the 3-week timeline
  • Achieved first-pass approval from all participating ethics committees
  • Enabled on-time trial startup across Europe, APAC, and Latin America
  • Enhanced sponsor confidence in multilingual readiness for future Phase III studies

This project illustrates Sesen’s ability to execute complex, large-scale clinical trial translation under compressed timelines—while maintaining full regulatory compliance and linguistic integrity.

Frequently Asked Questions (FAQ)

Sesen supports life sciences organizations with specialized, regulatory-compliant translation solutions tailored for clinical trial success. Below are answers to common questions about our multilingual clinical trial services.

Sesen provides end-to-end translation and localization for both patient-facing and trial management documents, including informed consent forms (ICFs), protocols, investigator brochures, site training materials, PROs/eCOA content, CRFs, safety narratives, and patient recruitment collateral.

Yes. We offer certified back translation and reconciliation for ICFs and other critical documents, in full alignment with EMA, FDA, and IRB requirements. Our back translation process ensures semantic equivalence and enhances regulatory confidence.

We offer expedited turnaround options for urgent trial needs, including site initiation packages and regulatory submissions. Typical timelines range from 3–7 business days, depending on language count, document complexity, and required validation.

Absolutely. Our linguists are native speakers with clinical, regulatory, or medical science backgrounds, and are specialized by therapeutic area—including oncology, cardiology, rare diseases, immunology, neurology, and more. This ensures terminology accuracy and contextual fluency.

While we do not offer standalone regulatory consulting, our translation workflows are built around global regulatory standards, including EMA, FDA, PMDA, and Health Canada requirements. We incorporate regulatory alignment into scoping, quality assurance, and formatting processes.