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What Is GCP and Why Accurate Translation Matters
Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human subjects. GCP ensures the rights, safety, and well-being of trial participants while maintaining the credibility and accuracy of clinical trial data.
Global regulatory agencies—including the International Council for Harmonisation (ICH E6[R2]), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA)—mandate strict adherence to GCP guidelines across all phases of clinical development. For multinational studies, precise translation of GCP-related documentation is essential to meet submission requirements, pass audits, and avoid costly delays.
Sesen’s GCP translation services help life sciences companies achieve full regulatory alignment across languages by delivering high-accuracy translations of critical documents such as SOPs, audit reports, and ethics committee submissions. We enable consistent global compliance and inspection readiness through specialized linguistic expertise and validated quality processes.
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Specialized GCP Documents We Translate
Sesen provides expert translation of Good Clinical Practice (GCP) documentation required for clinical trial planning, conduct, oversight, and reporting. Our linguists have clinical research expertise and in-depth knowledge of regulatory terminology to ensure translations meet global submission standards and audit expectations.
We support the full range of GCP-related materials, including:
Standard Operating Procedures (SOPs)
Translation of procedural documents governing clinical trial operations to maintain protocol compliance and regulatory alignment across multilingual teams.
Audit Reports & Inspection Findings
Accurate translations of regulatory audit documentation and inspection observations to support CAPA (Corrective and Preventive Actions) processes and cross-border regulatory reviews.
Informed Consent Forms (ICFs)
Precise and culturally appropriate translations of ICFs to ensure participant comprehension and meet IRB/ethics committee requirements globally.
Clinical Trial Protocols & Amendments
Translation of complex clinical protocols and amendments, preserving scientific intent, methodology, and investigational objectives in every language.
Case Report Forms (CRFs)
Linguistically accurate translations of CRFs to support consistent data collection and trial harmonization across international sites.
Investigator Brochures (IBs)
Translation of IBs with scientific and medical accuracy, ensuring investigators across regions receive reliable and compliant safety and efficacy information.
Ethics Committee & IRB Submissions
Support for multilingual submissions to ethics committees and institutional review boards, including cover letters, applications, and study materials.
Training Materials and Site Manuals
Localization of investigator training documents and site reference manuals to ensure uniform understanding of GCP procedures and protocol adherence.
Subject-facing Materials (e.g., diaries, instructions)
Clear and patient-friendly translations of instructions, diaries, and logs to improve participant compliance and data integrity.
Regulatory Expertise Across Global Authorities
Sesen’s GCP translation services are tailored to meet the diverse and evolving requirements of global regulatory bodies. Our expert linguists and regulatory consultants ensure that every document aligns with the specific standards and submission protocols of each region, reducing the risk of rejections, delays, or compliance gaps.
We provide GCP-compliant translations that support:
ICH E6(R2) Guidelines
Accurate alignment with the International Council for Harmonisation’s GCP framework, including sponsor responsibilities, monitoring, and documentation standards.
EMA and EU Member States
Expertise in EMA regulations and EU Clinical Trials Regulation (CTR), with precise translations for submission to national competent authorities and ethics committees across Europe.
FDA (U.S.)
Proven experience preparing GCP documentation for FDA audits, IND applications, and regulatory inspections with U.S.-specific terminology and formatting.
PMDA (Japan), NMPA (China), and MHRA (UK)
Region-specific translation and localization services to support submissions to Asian and UK regulatory authorities, incorporating linguistic and cultural nuances as required.
Our multilingual regulatory translation expertise spans all phases of the clinical trial lifecycle, enabling seamless international submissions and helping sponsors maintain compliance in complex, multi-country trials.
Professional Native Linguists with Clinical Research Expertise
At Sesen, all GCP translations are performed by professional native linguists with specialized backgrounds in clinical research and life sciences. Our translators are not only fluent in the target language but also deeply familiar with regulatory, scientific, and medical terminology specific to Good Clinical Practice (GCP) and broader GxP standards.
Every linguist assigned to GCP-related projects has:
- Proven experience translating clinical trial documentation, including SOPs, protocols, and ethics submissions
- Strong understanding of regulatory expectations under ICH E6(R2), FDA 21 CFR Part 11, and EU GCP requirements
- Adherence to rigorous quality systems certified under ISO 17100 (translation services) and ISO 9001 (quality management)
This ensures that your multilingual clinical documentation maintains accuracy, clarity, and compliance—helping you meet regulatory standards across global markets with confidence.
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Robust Quality Assurance and Review Protocols
Sesen applies a rigorous, multistage quality assurance (QA) process to all GCP compliance translations, ensuring linguistic precision, regulatory alignment, and inspection readiness. Our workflows are designed to meet the highest standards for accuracy, consistency, and traceability in life sciences documentation.
Key components of our QA process include:
Multistage Translation–Review–QA Workflow
Every project undergoes a structured sequence of professional translation, independent review, and final quality control by subject matter experts to ensure regulatory fidelity and linguistic clarity.
Translation Memory & Termbase Integration
We utilize client-approved translation memory (TM) and terminology databases to enforce consistency across documents and reduce turnaround times without compromising quality.
Parallel Proofreading & Formatting Checks
Final documents are reviewed for completeness, formatting accuracy, and readiness for submission or audit—ensuring all translated materials meet global regulatory expectations.
These QA protocols help maintain document integrity across languages and deliver compliant, inspection-ready translations for global clinical trials.
Human Translation Enhanced by Intelligent Tools
Sesen leverages advanced linguistic technologies to support high-accuracy human translation of GCP documentation while maintaining regulatory compliance and data integrity. Our approach integrates powerful tools to increase consistency, efficiency, and scalability—without compromising the quality and nuance required for clinical trial materials.
Our translation workflows feature:
- CAT Tool Integration for Terminology Control: Industry-standard computer-assisted translation (CAT) tools with built-in translation memory and termbase functionality ensure consistent use of validated clinical and regulatory terminology across all documents.
- Secure Cloud-Based Platforms & API Connectivity: We support real-time collaboration and seamless integration with client content management systems (CMS), electronic trial master files (eTMFs), and regulatory platforms via encrypted cloud environments and custom APIs.
- Hybrid Translation Workflows: Where appropriate, we incorporate machine translation post-editing (MTPE) to accelerate turnaround for high-volume content, always followed by expert human review to ensure compliance with GCP standards.
This harmonized translation approach enables faster, more reliable delivery of multilingual documentation for global clinical trials.
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Secure and Compliant Translation Workflow
Sesen upholds the highest standards of data privacy and regulatory compliance in every step of the GCP translation process. We understand the sensitivity of clinical trial documentation and implement strict safeguards to protect patient information, proprietary content, and sponsor confidentiality.
Our secure translation environment includes:
GDPR-Compliant Data Handling
Full compliance with the General Data Protection Regulation (GDPR) and other global data privacy laws for the processing of personally identifiable information (PII) and patient-sensitive data.
Role-Based Access Controls (RBAC)
Controlled access to project files and platforms based on user roles and responsibilities to limit data exposure and enhance workflow security.
Confidentiality Agreements & Encryption Protocols
All linguists and staff are bound by non-disclosure agreements (NDAs), and all data is transmitted and stored using enterprise-grade encryption and secure file transfer protocols (SFTP, TLS).
Our validated workflows ensure that all GCP-related translations meet the stringent security and compliance expectations of sponsors, CROs, and regulatory bodies worldwide.
Why Leading CROs and Sponsors Trust Sesen
Sesen delivers GCP translation services that are precisely aligned with the operational needs of clinical research organizations (CROs) and pharmaceutical sponsors. Our proven workflows, domain expertise, and responsive service model make us a reliable partner for clinical trial documentation across global markets.
Here’s why life sciences companies choose Sesen:
CRO and Sponsor-Aligned Workflows
Our translation processes are built around the regulatory and operational frameworks of global trial sponsors and CROs, ensuring seamless integration into existing document management and submission pipelines.
Clinical Trial-Savvy Project Managers
Every project is led by a dedicated project manager with hands-on experience in clinical research and GCP-regulated documentation, providing proactive communication and regulatory awareness throughout the engagement.
Fast Turnaround for Regulatory Timelines
We support accelerated study start-up and submission schedules with agile resourcing and streamlined processes that deliver accurate translations on time—without compromising compliance or quality.
With Sesen, sponsors and CROs gain a translation partner who understands the critical nature of clinical timelines, regulatory precision, and global coordination.
Request a Quote or Schedule a Consultation
Upload your documents securely through our encrypted portal to receive a customized quote. Prefer confidentiality first? We offer NDA execution prior to document sharing. Contact us today or schedule a consultation with our clinical translation experts.