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What Is Clinical Localization?

Clinical localization is the process of adapting clinical trial materials to meet the linguistic, cultural, and regulatory requirements of specific countries or regions. It goes beyond direct translation by ensuring that content is fully understood by local audiences and complies with relevant regulatory standards.

Unlike clinical translation, which focuses solely on converting text from one language to another, clinical localization incorporates cultural nuances, formatting conventions, regional medical terminology, and patient literacy levels. This holistic approach ensures that all clinical trial documentation, from informed consent forms and patient diaries to eCOA interfaces and regulatory submissions, is accurately tailored for local use.

Effective clinical localization is essential for improving patient comprehension, reducing protocol deviations, and supporting regulatory approval. It also plays a vital role in ensuring the integrity and comparability of clinical trial data across global sites, especially in multilingual studies where consistent interpretation is critical for successful outcomes.

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Why Clinical Localization Matters

Accurate clinical localization is critical for the success of global trials. It enables sponsors and CROs to engage diverse patient populations, comply with international regulatory standards, and collect reliable data across regions.

Localized patient-facing materials improve understanding, which directly supports patient recruitment, informed consent, and ongoing participation. When instructions and clinical content are adapted to local languages and cultural norms, trial participants are more likely to follow protocols correctly, reducing the risk of dropout or noncompliance.

Regulatory agencies such as the FDA, EMA, and PMDA increasingly expect submission-ready documentation that reflects linguistic accuracy and cultural relevance. Poorly localized content can result in delays, additional review cycles, or rejection.

Clinical localization also plays a central role in ensuring the validity of patient-reported outcomes. Misinterpretation caused by linguistic or cultural differences can compromise data quality and lead to inaccurate trial results. By addressing these challenges early, sponsors can safeguard the integrity of their studies and streamline global trial execution.

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Sesen’s Clinical Localization Capabilities

Sesen provides end-to-end clinical localization services designed to meet the demands of global trial operations. Our services are structured to ensure linguistic accuracy, regulatory compliance, and patient comprehension across all touchpoints of your clinical study.

Sesen localizes regulatory documentation to meet the specific submission standards of health authorities worldwide.

  • Clinical trial protocols, investigator brochures (IBs), informed consent forms (ICFs), and regulatory correspondence
  • Formatting for electronic trial master files (eTMFs) and submission-ready documents that align with FDA, EMA, PMDA, and regional authority guidelines

We adapt patient-facing materials to reflect cultural context, health literacy levels, and clinical intent without altering meaning.

  • Patient-reported outcomes (PROs), electronic PROs (ePROs), paper diaries, and multimedia instructions
  • Instructions for Use (IFUs), safety labeling, and culturally appropriate language adaptations to support understanding and adherence

Our services ensure that clinical site personnel receive localized materials that are clear, compliant, and actionable.

  • Clinical operations manuals, standard operating procedures (SOPs), and investigator training guides
  • Lab handling protocols, safety notifications, and dosing instructions for healthcare professionals

We leverage modern tools and AI-assisted workflows to streamline localization and improve consistency across regions.

  • Interface localization for eCOA and eConsent systems across mobile, tablet, and web-based platforms
  • Multilingual quality assurance (QA), linguistic validation, and in-country review to meet regulatory requirements
  • AI-powered translation support combined with expert human oversight for high-volume localization at scale

Languages and Therapeutic Areas We Support

Sesen provides clinical localization services in over 150 languages, supporting global trials across all major regions and therapeutic areas. Our global network of professional native linguists and medical subject matter experts enables precise and compliant localization tailored to each market.

We offer deep domain expertise in complex therapeutic areas, including oncology, rare and orphan diseases, central nervous system (CNS) disorders, gene and cell therapy, cardiology, dermatology, immunology, infectious diseases, and metabolic conditions.

Our localization capabilities span North America, Europe, Asia-Pacific (APAC), Latin America (LATAM), and the Middle East and North Africa (MENA). This regional coverage allows us to provide in-country insights and regulatory alignment across global study sites, ensuring consistency and clarity in every language.

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Regulatory and Quality Compliance

Sesen applies rigorous quality standards and regulatory expertise to every clinical localization project. Our workflows are fully certified to ISO 17100, ISO 9001:2015, and ISO 13485:2016, ensuring translation accuracy, process consistency, and alignment with life sciences industry requirements.

All linguists are trained in Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and the regulatory frameworks of the FDA, EMA, PMDA, and other regional health authorities. This specialized training allows us to deliver localization that meets the expectations of ethics committees, institutional review boards, and regulatory reviewers.

We implement robust terminology management protocols, enforce client-specific style guides, and conduct multi-step reviews to confirm linguistic precision and submission readiness. Our quality assurance process reduces rework, accelerates timelines, and supports successful global regulatory approvals.

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Clinical Localization Workflow

Sesen follows a structured and transparent localization process tailored to meet the demands of global clinical trials. Each step is designed to ensure linguistic accuracy, cultural relevance, and regulatory compliance across all target markets.

We begin by assessing project requirements, target regions, language pairs, file formats, and regulatory considerations. This ensures accurate planning, resource allocation, and timeline alignment.

Our team performs a detailed review of the source materials to identify medical terminology, regulatory references, patient-facing language, and any localization-sensitive elements.

Professional native linguists with therapeutic area expertise translate the content. In-country reviewers provide cultural adaptation and regional validation to ensure appropriateness for local populations.

A second linguist and a regulatory-trained reviewer validate the translation against source content, regulatory terminology, and formatting guidelines to ensure consistency and compliance.

Our quality assurance team performs a final check for completeness, formatting, and language accuracy before secure delivery. All files are prepared for submission or end use.

For patient-reported outcomes or sensitive clinical content, we offer back translation, reconciliation, and cognitive debriefing interviews to confirm conceptual equivalence and regulatory acceptance.

Technology Integration

Sesen integrates advanced technology solutions to streamline clinical localization and improve operational efficiency across global trials. Our platform supports seamless integration with industry-standard systems through secure APIs, enabling real-time content exchange and automated workflows.

We offer compatibility with electronic trial master file (eTMF) systems, clinical trial management systems (CTMS), and electronic data capture (EDC) platforms. This allows sponsors and CROs to localize regulatory and clinical content without disrupting internal processes or submission timelines.

Sesen also provides full support for eConsent and eCOA localization, including user interface adaptation and multilingual patient content alignment across digital platforms.

To enhance quality and consistency, we deploy AI-powered tools for glossary extraction, terminology alignment, and automated QA checks. These tools are combined with expert human review to ensure accuracy, reduce turnaround times, and maintain compliance across all languages.

Case Studies

Explore how Sesen delivers high-quality clinical localization services for global trials through real-world examples. These case studies highlight our expertise in regulatory alignment, patient engagement, and multilingual content validation.

Cognitive Debriefing in 22 Languages

For a Phase III hereditary condition study, Sesen conducted cognitive debriefing interviews across 22 languages to validate a patient-reported outcome measure. Our team managed linguistic validation, in-country recruitment, and cultural adaptation to support regulatory submission across multiple regions.

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Global Patient Engagement Campaign

Sesen partnered with a global biopharma sponsor to localize patient education materials in over 20 languages. We transcreated culturally resonant content, aligned messaging with regulatory requirements, and improved patient comprehension and enrollment across target markets.

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These examples reflect our ability to scale localization workflows and deliver high-impact results for clinical development teams worldwide.

Why Choose Sesen

Sesen is a trusted clinical localization partner focused exclusively on the life sciences. Our specialization ensures deep subject matter expertise, regulatory fluency, and unmatched quality across every project.

We support localization across all clinical trial phases, from startup to post-market, and across a broad range of therapeutic areas including oncology, rare diseases, CNS, and gene therapy. Our workflows are designed to scale quickly for high-volume, multi-language rollouts while maintaining precision and regulatory compliance.

With a global network of professional native linguists and 24/7 operational support, we provide fast turnaround and in-country insight for every target region. Each client engagement is led by a dedicated project manager who ensures seamless communication, timeline adherence, and customized service delivery through flexible per-language, per-document, or FTE-based models.

Choosing Sesen means working with a partner who understands the complexities of global trials and delivers consistently reliable localization outcomes.

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Related Services

Sesen offers a full suite of specialized services that complement clinical localization and support global trial success. Explore our related solutions designed to ensure clarity, compliance, and patient-centered communication at every stage of the clinical development process:

Ensure concept equivalence for translated PRO instruments through reconciliation, back translation, and cognitive debriefing. Learn more about our full linguistic validation services.

Localize user interfaces and patient-facing content across mobile and tablet platforms for global deployment. Explore our eConsent and eCOA localization solutions.

Translate clinical protocols, IBs, CRFs, and regulatory submissions with subject-specific accuracy. Visit our clinical trial translation services page for more details.

Adapt Instructions for Use, packaging inserts, and safety labeling in compliance with global device and pharmaceutical regulations. See our IFU and labeling translation offerings.

Create culturally relevant, multilingual content to support patient recruitment, education, and retention. Learn how we help drive outcomes through patient engagement localization.

Each service is delivered by experienced life sciences linguists and supported by ISO-certified quality processes to ensure global consistency and compliance.

Ready to Streamline Your Global Trial Localization?

Sesen delivers expert clinical localization services designed for regulatory compliance, global reach, and patient understanding. Whether you need multilingual rollout, validated patient content, or digital platform localization, our team is ready to support your trial success.

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