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What Is an Investigator’s Brochure?

An Investigator’s Brochure (IB) is a comprehensive scientific document that compiles all relevant clinical and nonclinical data about an investigational product. Required by ICH E6(R2) Good Clinical Practice guidelines, the IB serves as a critical reference for investigators and site staff throughout the lifecycle of a clinical trial.

The brochure consolidates information on the drug’s pharmacological properties, safety profile, dosing strategy, and previous trial outcomes. Its primary function is to provide investigators with the necessary background to make informed decisions about patient eligibility, dosing adjustments, and risk management. Ethics committees and institutional review boards (IRBs) also rely on the IB to evaluate the safety and scientific validity of the proposed study.

In global trials, the IB must be translated with precision and scientific accuracy to ensure consistent understanding across all study sites. Misinterpretation of content can lead to protocol deviations, regulatory delays, or compromised patient safety. Sesen delivers professionally translated IBs that support informed consent, ethical oversight, and seamless global execution.

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Why Accurate IB Translation Is Critical

Investigator’s Brochures contain essential data that guide clinical decision-making, inform ethical oversight, and support regulatory submissions. Accurate translation of this content is vital for the success and integrity of global clinical trials.

High-quality IB translation prevents misinterpretation of investigational product data, including safety signals, dosing protocols, and pharmacological mechanisms. Inaccuracies can lead to protocol deviations, adverse patient outcomes, and costly trial delays.

Precise translations ensure regulatory and ethical compliance in each participating country. Ethics committees, institutional review boards (IRBs), and competent authorities require localized content that clearly communicates the scientific rationale and safety assessments in the target language.

Consistent language across translated IBs enables uniform understanding and implementation of the clinical protocol by investigators and site staff. This alignment is critical for maintaining data integrity and meeting Good Clinical Practice (GCP) standards.

Finally, accurate translation supports timely and successful submissions to local regulatory bodies. Sesen delivers linguistically and scientifically validated IBs that meet regional requirements, helping sponsors avoid approval setbacks and maintain global trial momentum.

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Comprehensive IB Translation and Localization Services

Sesen provides end-to-end translation and localization solutions for Investigator’s Brochures, ensuring scientific accuracy, regulatory readiness, and seamless delivery across languages. Our services cover all critical content and formatting elements required for global clinical trial compliance.

We translate and localize the full scope of IB content, including:

  • Detailed product descriptions and the investigational product’s mechanism of action
  • Preclinical and clinical safety data, including toxicology and pharmacology studies
  • Pharmacokinetic and pharmacodynamic profiles to support dosing strategies
  • Dosing instructions, contraindications, and adverse event reporting protocols
  • Guidelines for investigational product handling, storage, and administration
  • Historical revisions and version control tracking for ongoing amendments

In addition to translation, our services include:

  • Multilingual desktop publishing (DTP) to deliver professionally formatted, submission-ready documents tailored to local regulatory templates
  • In-country review and reconciliation to incorporate local feedback and ensure cultural and regulatory alignment when required
  • Linguistic validation support for any patient-facing content within the IB, following industry standards for conceptual equivalence and clarity

Each project follows a structured workflow that includes medical review, bilingual quality assurance, and terminology consistency checks using client-approved glossaries and translation memories. Whether you are preparing your first IB or updating a revision for multi-country expansion, Sesen provides the linguistic precision and technical rigor needed for successful execution.

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Regulatory and Quality Standards We Follow

Sesen delivers Investigator’s Brochure translations through certified processes that meet the highest standards for accuracy, consistency, and compliance in clinical research.

Our workflows are fully certified under ISO 17100 for translation services and ISO 9001:2015 for quality management systems. These certifications ensure structured project execution, traceable quality controls, and continuous improvement practices.

We align all translations with global regulatory requirements, including ICH-GCP, EMA, FDA, PMDA, and applicable local ethics committee guidelines. This ensures that every localized IB supports proper investigator training, ethical review, and clinical trial authorization in each target region.

Our quality assurance and quality control (QA/QC) processes include bilingual review, terminology verification, and independent third-party proofreading. Each translation undergoes a thorough validation to ensure scientific accuracy and consistency with source documents.

We engage native-language medical reviewers, typically MDs or PhDs, to evaluate complex scientific and clinical content. Their review ensures that key information, such as safety data, pharmacology, and dosing, is accurately conveyed in every target language.

To maintain consistency across IB updates and trial documents, we apply client-approved glossaries, style guides, and translation memories. This approach supports long-term linguistic alignment across your clinical programs and regulatory submissions.

By adhering to these standards, Sesen helps sponsors and CROs reduce risk, accelerate review timelines, and ensure full compliance in global clinical trials.

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Expert Linguists and Medical Reviewers

At Sesen, every Investigator’s Brochure is translated by a team of native linguists and medically trained experts with direct experience in clinical trials and life sciences.

Our translators are native professionals with deep subject matter expertise in therapeutic areas such as oncology, cardiology, neurology, and rare diseases. They understand the clinical context and technical terminology required for accurate and compliant IB translation.

Each project is also optionally reviewed by MDs or PhDs in the target language, who verify the scientific integrity of the content. These reviewers assess critical sections such as pharmacokinetics, safety data, dosing strategies, and investigational product mechanisms to ensure clarity and regulatory alignment.

Our linguists and reviewers have proven experience translating into over 150 languages, supporting global clinical programs across North America, Europe, Asia, and Latin America. Whether the IB is intended for a regional ethics committee or multiple country submissions, Sesen delivers linguistically precise and medically validated translations that meet local and international standards.

By combining linguistic precision with medical insight, our team ensures your IB communicates complex scientific content clearly and consistently to investigators and regulators worldwide.

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Translation Process Overview

Sesen follows a structured and quality-driven workflow for translating Investigator’s Brochures, designed to ensure scientific accuracy, regulatory compliance, and seamless global delivery. Each project is managed by experienced professionals and adheres to industry best practices.

Our Investigator’s Brochure Translation Workflow includes the following steps:

We begin with a detailed analysis of the source IB, clarifying scope, target languages, regulatory requirements, and project timelines.

Our team identifies key scientific terms, product-specific language, and reference materials. We align on approved glossaries and style guides to maintain consistency across documents.

Native linguists with clinical trial and life sciences expertise translate the content using translation memory tools to ensure linguistic consistency and efficiency.

Each translation is reviewed by medically trained professionals, typically MDs or PhDs, in the target language to verify scientific accuracy and regulatory clarity.

Independent linguists perform a final QA check to ensure the translation meets quality standards. This includes terminology validation, formatting checks, and linguistic accuracy.

Our desktop publishing specialists format the translated documents to match regulatory submission templates and ensure professional layout in all target languages.

We incorporate feedback from sponsor teams, CROs, or in-country reviewers to finalize content based on local expectations or regional guidelines.

The completed IB is delivered in the required file format, fully validated, and ready for submission to ethics committees, IRBs, and regulatory authorities worldwide.

This rigorous process ensures that every translated Investigator’s Brochure from Sesen is scientifically accurate, culturally appropriate, and fully aligned with the requirements of global clinical trials.

Support for Global Submissions

Sesen provides specialized translation services for Investigator’s Brochures that meet the diverse requirements of global regulatory bodies and ethics committees. Our multilingual solutions are tailored to support submissions across all major clinical trial regions.

We deliver translations aligned with regional regulatory authorities, including ANVISA in Brazil, PMDA in Japan, Health Canada, NMPA in China, and others. Each translation reflects the terminology preferences, formatting expectations, and regulatory guidance specific to the target jurisdiction.

Our deliverables are prepared in compliance-ready formats that meet the documentation standards of institutional review boards (IRBs), ethics committees, and national competent authorities. We ensure clear presentation of safety data, clinical rationale, and product information to facilitate timely ethical and regulatory review.

For multicountry clinical trials, we apply localization strategies that balance linguistic precision with global consistency. This includes harmonizing key terminology across languages while adapting content to cultural and regulatory nuances in each market. Our integrated translation memory and glossary tools streamline updates and reduce turnaround times across multiple jurisdictions.

With Sesen, sponsors and CROs gain a reliable partner for navigating the complex linguistic and regulatory landscape of international clinical trial submissions.

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Case Study: Multilingual IB Translation for a Global Phase III Trial

A leading biopharmaceutical company engaged Sesen to support a global Phase III oncology study involving over 30 clinical sites across North America, Europe, Asia, and Latin America. The client required urgent translation of an updated Investigator’s Brochure into 20 target languages, including Japanese, Korean, Brazilian Portuguese, and Russian, for submission to local ethics committees and regulatory authorities.

Sesen deployed a dedicated team of native linguists with oncology expertise, along with MD reviewers in each target language to validate scientific accuracy and regulatory alignment. We applied the client’s existing terminology and style guide while updating the translation memory to ensure consistency across all trial documents.

Despite the compressed timeline, our team delivered submission-ready translations within ten business days, complete with bilingual QA, multilingual formatting, and country-specific layout adjustments. The translated IBs were used in ethics committee submissions and site trainings across all regions, contributing to the trial’s on-time activation.

This project demonstrates Sesen’s ability to manage complex, time-sensitive Investigator’s Brochure translations at global scale while maintaining full compliance with international regulatory and ethical standards.

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Why Life Sciences Leaders Choose Sesen

Sesen is a trusted partner for life sciences organizations seeking high-quality, regulatory-compliant translations for global clinical trials. Our exclusive focus on life sciences ensures that every project benefits from domain expertise, technical accuracy, and deep regulatory insight.

We specialize in supporting pharmaceutical, biotechnology, and contract research organizations with specialized translation workflows built for clinical research. Our teams understand the language of clinical development, including terminology specific to Investigator’s Brochures, protocols, and safety reports.

Sesen’s regulatory expertise spans global health authorities, including FDA, EMA, PMDA, and Health Canada. We tailor our processes to align with country-specific submission formats and ethical review expectations, helping sponsors avoid costly delays and rework.

Our project management model is agile and responsive, with dedicated account managers who ensure transparency, timely communication, and full control over each translation project. We use a secure, cloud-based infrastructure that supports version control, reviewer access, and data protection in compliance with international standards.

With a proven track record of on-time delivery for complex, multicountry clinical trials, Sesen combines scale with precision. Our experience includes successful collaboration with top-tier pharma and biotech sponsors, as well as global CROs managing trials across dozens of regions and languages.

By choosing Sesen, life sciences companies gain a strategic language partner that delivers accuracy, speed, and global readiness across every stage of clinical development.

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Related Services

Explore other clinical trial translation services that complement your Investigator’s Brochure localization:

Need Accurate Investigator’s Brochure Translations for Your Global Trial?

Work with Sesen to ensure your Investigator’s Brochure is professionally translated, medically reviewed, and fully compliant with regional regulatory requirements. We support over 150 languages with native linguists, MD reviewers, and ISO-certified workflows designed for global clinical success.

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