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Precision Language Solutions for CROs

Clinical Research Organizations (CROs) play a critical role in advancing global drug development, from clinical trials to regulatory approvals. In an industry where precision and compliance are crucial, accurate, high-quality translation is essential for ensuring regulatory alignment, patient safety, and seamless global trial execution.

At Sesen, we specialize in CRO translation services, delivering multilingual solutions that meet the strict linguistic and regulatory standards of EMA, FDA, MHRA, PMDA, and other global agencies. Whether translating clinical trial protocols, informed consent forms, or regulatory submissions, our expert linguists and life sciences specialists ensure that every document maintains scientific accuracy, cultural relevance, and regulatory compliance.

With a proven track record in life sciences translation, we empower CROs to accelerate global studies, improve patient engagement, and streamline regulatory approvals—all while reducing language-related delays and risks.

Expert Translation for Every Phase of Clinical Research

  • Regulatory Submissions & Compliance Documents
  • Clinical Trial Protocols & Patient-Facing Materials
  • eCOA, ePRO, and CTMS Localization
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Comprehensive CRO Translation Services

Sesen provides specialized translation solutions for Clinical Research Organizations (CROs), maintaining accuracy, compliane, and multilingual consistency across every phase of clinical research. By integrating linguistic validation, back translation, and regulatory alignment, our expert linguists, subject matter specialists, and regulatory professionals deliver precise translations that meet the stringent requirements of global health authorities and regulatory bodies.

Essential Clinical Document Translation

Sesen translates critical clinical trial documents to support global research, ensuring accuracy, regulatory compliance, and linguistic consistency.

Sesen translates complex study methodologies and trial procedures to ensure consistency across multilingual sites.
Example: “Randomized, double-blind, placebo-controlled trial of [drug name] in patients with [condition]” → “Ensayo aleatorizado, doble ciego, controlado con placebo de [nombre del fármaco] en pacientes con [condición].”

Our team delivers precise translations of drug mechanisms, pharmacokinetics, and safety data for international research teams.
Example: “Adverse reactions were observed in 5% of subjects during phase I trials.” → “Se observaron reacciones adversas en el 5 % de los sujetos durante los ensayos de fase I.”

We ensure accurate data capture across diverse patient populations with clear, structured translations.
Example: “Please record any adverse events in the provided table, specifying onset and duration.” → “Registre cualquier evento adverso en la tabla proporcionada, especificando el inicio y la duración.”

Sesen enhances patient comprehension while maintaining regulatory compliance through culturally adapted translations.
Example: “By signing below, you acknowledge that you understand the potential risks and benefits of this study.” → “Al firmar a continuación, reconoce que comprende los posibles riesgos y beneficios de este estudio.”

Our team localizes outreach materials to maximize engagement and patient retention in global trials.
Example: “Join our clinical trial and help advance medical research for [condition].” → “Únase a nuestro ensayo clínico y ayude a avanzar en la investigación médica para [condición].”

We meet stringent FDA, EMA, PMDA, and global regulatory requirements with accurate, format-compliant translations.
Example: “This submission complies with the ICH guidelines for electronic Common Technical Document (eCTD) format.” → “Esta presentación cumple con las directrices de ICH para el formato electrónico del Documento Técnico Común (eCTD).”

Sesen ensures linguistic validation for accurate patient data collection in multinational studies.
Example: “On a scale from 1 to 10, rate your pain level over the past 24 hours.” → “En una escala del 1 al 10, califique su nivel de dolor en las últimas 24 horas.”

Regulatory & Compliance Translation

CROs must comply with regional and international regulatory requirements for clinical trials. Sesen provides high-precision translations that meet industry guidelines.

We ensure compliance with International Council for Harmonisation – Good Clinical Practice (ICH-GCP) standards to meet ethical and regulatory requirements across regions.

Our translation experts adapt documents for EMA, FDA, MHRA, PMDA, and other global health agencies, ensuring country-specific terminology and formatting.

We provide eCTD-compliant translations that align with electronic regulatory submission standards, ensuring smooth approval processes.

Patient-Facing Translations

Accurate, patient-friendly translations are essential for patient engagement and compliance in clinical trials. Sesen ensures accessibility through culturally adapted content.

We translate PRO questionnaires to collect reliable patient feedback across multiple languages while preserving clinical validity.

Our linguistic validation and back translation processes ensure that patient-reported data is clear, accurate, and culturally relevant.

Sesen translates and localizes eConsent forms, digital patient materials, and web portals, ensuring seamless multilingual patient interactions.

Software & eClinical System Localization

CROs rely on advanced electronic clinical technologies to streamline research. We provide specialized localization for clinical software systems.

Sesen translates and adapts electronic Clinical Outcome Assessments (eCOA), electronic Patient Reported Outcomes (ePRO), and Clinical Trial Management Systems (CTMS) for multilingual use.

Our localization team ensures usability, compliance, and linguistic accuracy for electronic patient engagement tools, mobile apps, and clinical trial tracking systems.

Industry-Leading Expertise in CRO Translation

Sesen delivers highly specialized CRO translation services, combining linguistic precision with deep industry expertise. Our certified translators, life sciences specialists, and regulatory experts ensure every translation meets the highest standards of accuracy, compliance, and clarity for global clinical research.

Our linguists are clinical research specialists with expertise in biopharmaceuticals, medical devices, and regulatory affairs. They are well-versed in technical terminology, clinical trial protocols, and regulatory documentation to ensure scientifically accurate translations.

Sesen’s translation processes adhere to ISO 17100 (Translation Services) and ISO 9001:2015 (Quality Management), ensuring consistent accuracy, traceability, and compliance with global regulatory requirements.

We provide DTP services for patient materials, regulatory submissions, and technical documentation, ensuring precise formatting and language consistency across all languages. This guarantees that translated documents adhere to strict submission and compliance guidelines.

Sesen leverages AI-assisted quality assurance tools to enhance terminology consistency, formatting accuracy, and translation memory utilization, while expert linguists ensure scientific and regulatory precision. This approach reduces errors, accelerates workflows, and maintains the highest level of linguistic accuracy across multilingual clinical documentation.

With decades of experience supporting CROs, pharmaceutical companies, and biotech firms, Sesen ensures that every translation is scientifically accurate, culturally relevant, and fully compliant with regulatory expectations.

Achieving Quality & Accuracy

Sesen applies rigorous quality control measures to ensure precision, regulatory compliance, and linguistic consistency in every translation. Our specialized workflows, expert linguists, and technology-driven validation processes guarantee the highest accuracy across multilingual clinical documentation.

Our linguistic validation process ensures clarity, accuracy, and cultural relevance in Patient Reported Outcomes (PROs), Clinical Outcome Assessments (COAs), and informed consent forms. This includes cognitive debriefing and subject matter expert review to confirm that translations are easily understood and scientifically precise.

To meet EMA, FDA, and ICH-GCP standards, we perform back translation and reconciliation for critical clinical trial documents. This process identifies discrepancies, enhances accuracy, and ensures regulatory alignment for multilingual submissions.

Sesen maintains customized terminology databases and CRO-specific glossaries to ensure consistent use of scientific terms, drug names, and regulatory phrasing across all translations. Our controlled vocabularies align with industry standards, including MedDRA and SNOMED CT, preventing misinterpretation and improving document integrity.

We develop customized, client-specific glossaries to standardize terminology across projects. Our glossary management approach ensures that preferred terms, abbreviations, and key clinical phrases remain uniform in all translations, improving efficiency and quality.

Our Translation Memory (TM) technology stores previously approved translations to enhance consistency, reduce turnaround times, and minimize costs. This ensures that repeated content—such as regulatory documents and protocol amendments—remains accurate and aligned with prior translations.

Sesen leverages AI-driven translation tools to support human translators by identifying inconsistencies, flagging errors, and optimizing formatting. These tools enhance quality control without replacing the expertise of our life sciences linguists.

With our proven quality assurance framework, Sesen guarantees that clinical research translations are precise, compliant, and patient-friendly, helping CROs accelerate global trials with confidence.

Global Language Coverage for Clinical Trials

Sesen provides multilingual translation solutions to support clinical trials in over 150 languages, ensuring regulatory compliance, patient engagement, and scientific accuracy across diverse linguistic and cultural landscapes. Our global network of certified life sciences linguists delivers precise, regionally adapted translations to facilitate seamless international research.

We specialize in high-demand languages for global clinical trials, including French, German, Spanish, Chinese, Japanese, Russian, Arabic, Portuguese, Italian, Hindi, and Korean. Our expertise ensures that critical regulatory documents, informed consent forms, and patient materials are linguistically and culturally accurate for diverse populations.

Sesen provides expert translation services for African and Southeast Asian languages, including Swahili, Amharic, Burmese, Khmer, Lao, Tagalog, and more. As clinical trials expand into underserved regions, we help CROs navigate local regulatory requirements and linguistic challenges with precise, culturally adapted translations.

Our team manages large-scale, multi-language translation projects, ensuring terminology consistency, version control, and regulatory compliance across multiple sites. With specialized project managers and AI-assisted quality control tools, we streamline the translation process, reducing delays and maintaining accuracy across all clinical documentation.

With support for over 150 languages, Sesen’s end-to-end language solutions enable CROs to conduct international clinical trials with confidence, ensuring linguistic precision, regulatory alignment, and patient accessibility in every market.

Case Studies & Success Stories

Sesen has a proven track record of delivering high-quality, regulatory-compliant translations for Clinical Research Organizations (CROs) and pharmaceutical companies worldwide. Our expertise in clinical trial translation, regulatory submissions, and patient engagement has helped organizations navigate multilingual challenges and accelerate global clinical research.

Expanding a CRO’s Reach in Asian Markets

Client: PPD (A leading global CRO)

Challenge: PPD needed clinical trial protocols and regulatory documents translated into Korean, Chinese, and other Asian languages for submission to NMPA (China), PMDA (Japan), and MFDS (South Korea). The translations had to meet strict regulatory standards while maintaining scientific accuracy.

Solution:

  • Assembled a dedicated team of native-speaking linguists with expertise in regulatory affairs
  • Conducted terminology alignment and quality assurance checks to ensure consistency across multiple languages
  • Delivered certified translations compliant with NMPA, PMDA, and MFDS regulatory guidelines

Results:

  • Facilitated faster regulatory approvals in China, Japan, and South Korea
  • Helped PPD launch multinational clinical trials with streamlined language workflows
  • Ensured consistency and accuracy in all translated documentation

Client: A U.S.-based pharmaceutical company

Challenge: The company required precise translations of eCTD (electronic Common Technical Document) submissions for FDA approval. Any inconsistencies or mistranslations could result in regulatory delays.

Solution:

  • Deployed ISO 17100-certified translators with expertise in regulatory submissions
  • Applied Translation Memory (TM) technology to ensure consistency across multiple document versions
  • Performed back translation and reconciliation to validate the accuracy of critical regulatory content

Results:

  • Helped the client achieve FDA approval ahead of schedule
  • Eliminated language-related regulatory risks
  • Optimized translation workflows, reducing costs and turnaround times

Client: A global CRO managing a multi-country clinical trial

Challenge: Low patient enrollment due to complex, difficult-to-understand recruitment materials that were not culturally adapted for Spanish- and Arabic-speaking populations.

Solution:

  • Conducted linguistic validation and readability testing to ensure materials were patient-friendly
  • Localized informed consent forms, brochures, and outreach campaigns for target demographics
  • Ensured terminology alignment with patient literacy levels and cultural expectations

Results:

  • Increased patient enrollment significantly in key target markets
  • Improved patient understanding and trial retention rates
  • Strengthened the client’s global trial outreach strategy

Sesen’s expert-driven approach to clinical translation has helped CROs and pharmaceutical companies achieve regulatory success, improve patient engagement, and accelerate global trials.

Why Choose Sesen for CRO Translation Services?

Sesen is a trusted partner for Clinical Research Organizations (CROs), delivering highly accurate, regulatory-compliant translations that support global clinical trials, regulatory submissions, and patient engagement. Our specialized expertise, industry-leading quality standards, and flexible service models ensure that CROs can expand their reach, accelerate approvals, and streamline multilingual clinical research.

Sesen’s linguists are clinical research and regulatory specialists with expertise in pharmaceuticals, biotechnology, and medical devices. Our team includes subject matter experts (SMEs), certified translators, and regulatory professionals who ensure that translations adhere to industry terminology and compliance requirements.

We have successfully partnered with leading CROs, pharmaceutical companies, and biotech firms, providing high-accuracy translations for clinical protocols, eCTD submissions, informed consent forms, and patient materials. Our work has helped clients navigate regulatory complexities and accelerate international trials.

Sesen meets the highest industry standards, ensuring translations comply with ISO 17100 (Translation Services), FDA, EMA, ICH-GCP, MHRA, PMDA, and other global regulatory agencies. Our quality-driven processes include back translation, linguistic validation, and terminology management, reducing regulatory risks and ensuring submission-ready documentation.

We provide scalable, customized translation solutions to meet the dynamic needs of CROs, including:

  • Rush translations for time-sensitive regulatory submissions
  • Large-scale multilingual projects covering 150+ languages
  • Ongoing translation partnerships with dedicated teams for long-term clinical research programs

With a deep understanding of clinical trial complexities and regulatory expectations, Sesen delivers best-in-class CRO translation services that enable global research success

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