Nonclinical Evidence
Pharmacology, toxicology, pharmacokinetics, animal studies, and other findings that establish the scientific foundation for clinical investigation.
150+ Languages
Global multilingual support
Life Sciences
Specialized linguistic expertise
ISO-Certified
Quality-controlled processes
AI-Assisted QA
Human-reviewed delivery
An Investigator’s Brochure Brings Evolving Evidence Together
An Investigator’s Brochure is not one isolated body of text. It brings together the scientific information investigators and other study stakeholders need to understand the investigational product, the rationale for its use, and important considerations for administration and safety monitoring.
For multilingual studies, the challenge is therefore not simply translating one document accurately. The scientific relationships within the IB must remain intact across every required language and every subsequent version.
ICH E6(R3) Context
The current ICH Good Clinical Practice framework describes the Investigator’s Brochure as a compilation of relevant clinical and nonclinical data and connects it directly with investigator understanding of dose, dosing frequency, administration, and safety monitoring.
Clinical Evidence
Previous human exposure, clinical observations, efficacy findings, safety findings, dose-related experience, and evidence generated through development.
Clinical Pharmacology & PK/PD
Mechanism of action, pharmacodynamics, pharmacokinetics, exposure, metabolism, dose-response information, and related scientific terminology.
Safety & Reference Safety Information
Known and emerging safety findings, adverse reactions, risk information, safety monitoring considerations, and RSI where applicable.
Dosing & Administration
Dose levels, schedules, routes of administration, treatment duration, dose modifications, instructions, and the clinical rationale behind them.
Investigational Product Information
Product identity, pharmaceutical characteristics, formulation, physical properties, handling information where included, and related technical content.
Scientific Evidence Has to Remain Connected Across Languages
A technically correct sentence can still create a problem if it does not align with information elsewhere in the Investigator’s Brochure.
A product term used in a nonclinical section may reappear in clinical pharmacology. A dose discussed in clinical evidence may need to match administration guidance. An adverse reaction described in one safety section may also appear in Reference Safety Information. Study identifiers, abbreviations, units, tables, and references can recur throughout the document.
Scientific Accuracy Is More Than Sentence-by-Sentence Translation
Context determines whether a term describes an observed finding, a potential risk, a mechanism, a dosing instruction, or a product characteristic. Qualified wording and scientific distinctions must not be strengthened, weakened, or unintentionally generalized in another language.
Investigational product names and identifiers
Indications and therapeutic terminology
Medical, pharmacology, and PK/PD terminology
Dose levels, frequency, route, and administration language
Safety, adverse-reaction, and RSI terminology
Units, concentrations, percentages, and numerical values
Study identifiers, acronyms, and abbreviations
Tables, figures, references, and internal cross-references
Nonclinical Findings
Clinical Evidence
Pharmacology & PK/PD
Dose & Administration
CONTROLLED MULTILINGUAL INVESTIGATOR’S BROCHURE
Safety & RSI
Product Information
SAFETY & RSI
Safety Information Has to Stay Current Across Every Language
Safety content deserves particular attention because an Investigator’s Brochure can change as additional exposure and clinical information become available.
Under ICH E6(R3), the IB or other current scientific information supports clinical-trial safety assessment and reporting, while Reference Safety Information in the IB provides an important reference for expectedness in expedited SUSAR reporting.
Multilingual IB safety content may include adverse reactions, known and potential risks, emerging safety findings, safety monitoring information, relevant medical terminology, Reference Safety Information, and safety-related revisions.
- Adverse reactions
- Nature and frequency of reactions
- Known and potential risks
- Emerging safety findings
- Safety monitoring information
- Reference Safety Information
- Medical and pharmacovigilance terminology
- Safety-related amendments
Dose and Product Information Cannot Drift Between Sections
The rationale for a particular dose may originate in pharmacology or toxicology findings, develop through clinical experience, appear in dose-response information, and ultimately connect with administration and safety monitoring. Sesen helps maintain those relationships without reinterpreting the approved science.
Pharmacology
PK/PD
Dose Rationale
Administration
Clinical Evidence
Safety
These same concepts can also appear in the clinical trial protocol. When approved reference documents are available, Sesen can align critical terminology between the IB and related study content. Explore Protocol Translation Services
A Structured Workflow for Multilingual Investigator’s Brochures
Every IB program has its own source history, language requirements, existing translations, terminology resources, review pathway, file formats, and release schedule. Sesen builds the workflow around those requirements while maintaining structured linguistic and quality controls.
01
Source & Scope Review
Review the current IB, languages, locales, previous editions, existing translations, sponsor references, file formats, timelines, and delivery requirements.
02
Terminology & Reference Alignment
Align product, medical, safety, pharmacology, dose, and study terminology with approved glossaries, translation memories, prior IBs, protocols, and authorized references.
03
Specialized Life Sciences Translation
Assign qualified linguists with relevant medical, pharmaceutical, scientific, or clinical research expertise for the language pair and content.
04
Independent Linguistic Review
Review the translation against the source for scientific meaning, completeness, terminology, numerical content, and consistency.
05
Document & Cross-Reference QA
Check critical terminology, doses, units, identifiers, tables, figures, section numbering, cross-references, references, and repeated content.
06
Formatting & Document Engineering
Preserve or recreate complex IB structures including tables, figures, headers, footers, numbered sections, references, and multilingual page layouts.
07
Final QA & Controlled Delivery
Complete final linguistic and production checks before delivery of the approved target-language files and agreed project documentation.
AI-ASSISTED QUALITY CONTROL
Technology Helps Surface Risk. Experts Make the Quality Decisions.
For suitable Investigator’s Brochure workflows, Sesen can combine translation memory, terminology governance, controlled AI assistance, AI-assisted validation, and qualified human review.
Technology-supported checks help reviewers find patterns and potential inconsistencies faster. Qualified life sciences linguists and reviewers remain responsible for evaluating context, scientific meaning, terminology, and final multilingual quality.
Terminology inconsistencies
Numerical and unit mismatches
Dose discrepancies
Missing or added content
Acronym inconsistencies
Structural differences
Repeated-content inconsistencies
Version-change deviations
Keep the IB Aligned With the Rest of the Clinical Documentation Set
An Investigator’s Brochure does not operate independently from the rest of a clinical study.
Scientific concepts and approved terminology can move among protocols, safety documentation, regulatory materials, ethics submissions, consent updates, study manuals, and other clinical documentation. Managing those relationships helps reduce terminology drift as studies and documents evolve.
Protocol
Product terminology, dose, administration, safety concepts, clinical rationale, and study-specific terms.
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Pharmacovigilance
Evolving safety information can affect the IB and the broader safety-documentation ecosystem.
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Regulatory Submissions
Clinical and nonclinical evidence may also appear across submissions and supporting regulatory documentation.
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IRB / Ethics
Current IB versions and updates can form part of ongoing ethics-review documentation.
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Clinical Study Docs
The IB belongs within the broader multilingual documentation required throughout international studies.
ExploreLIFECYCLE MANAGEMENT
The Investigator’s Brochure Changes as Clinical Knowledge Changes
New nonclinical findings, clinical data, safety information, RSI changes, dosing experience, and product information can drive source IB revisions. ICH E6(R3) calls for the IB to be reviewed at least annually and revised as necessary, with more frequent revision potentially appropriate as important new information emerges. For multilingual studies, each source change can create a downstream version-management requirement.
SOURCE IB
V1
MULTILINGUAL
V1
NEW EVIDENCE
+ SAFETY
SOURCE IB
V2
MULTILINGUAL
V2
Baseline Version Control
Establish the current approved source and target-language versions as the basis for future updates.
Change Identification
Compare new source editions against previous versions to identify added, revised, moved, or removed content.
Controlled Amendment Translation
Translate affected content while preserving appropriate previously approved language in unchanged sections.
Terminology Continuity
Reuse approved terminology, translation memory, sponsor preferences, and prior reviewer decisions across successive editions.
Multilingual Synchronization
Coordinate required target languages so study teams can identify which release corresponds to the current approved source.
Document-Level QA
Verify version identifiers, dates, numbering, references, tables, figures, and formatting affected by the update.
The objective is not simply to translate each new edition—it is to preserve continuity from one approved multilingual version to the next.
For recurring programs, approved terminology, reviewer decisions, translation memories, reference documentation, and prior quality findings can carry forward so each new release starts from an established multilingual baseline rather than from zero.
One Source Investigator’s Brochure. Multiple Languages. Controlled Delivery.
Multinational clinical programs may involve one language, dozens of languages, simultaneous country launches, phased market activation, or recurring updates over several years.
Sesen supports single-language projects and coordinated multilingual IB programs, including country- and region-specific language variants where appropriate.
150+
Supported languages
Complete Investigator’s Brochure translation
Individual revised sections
IB amendments and new editions
Multilingual parallel production
Translation-memory and approved-content reuse
Terminology management
Safety and RSI updates
Formatting and DTP
Tables and figures
Reviewer feedback incorporation
Version reconciliation
Certificates of translation accuracy when requested
Coordinated multilingual release schedules
Ongoing clinical development translation programs
Quality Controls Designed for Clinical and Scientific Content
Investigator’s Brochures combine high-value scientific information with ongoing clinical and safety relevance. Sesen applies a quality framework built for regulated life sciences content and multilingual continuity.
Specialized Medical & Scientific Linguists
Project teams are selected according to language pair, subject matter, therapeutic area, document type, and program requirements.
Independent Linguistic Review
Where included in the workflow, a second qualified linguist reviews accuracy, completeness, terminology, scientific meaning, and consistency.
Controlled Terminology
Sponsor glossaries, approved product terminology, translation memories, previous translations, and reviewer feedback can be maintained as reusable linguistic assets.
Numerical & Data QA
Structured checks support review of doses, concentrations, units, percentages, dates, study numbers, identifiers, tables, and repeated numerical information.
Structural QA
Document-level review covers hierarchy, tables, figures, cross-references, footnotes, references, pagination, headers, footers, and version information.
Human Final Quality Control
Qualified professionals retain responsibility for evaluating context, scientific meaning, terminology, and final multilingual quality before delivery.
Investigator’s Brochure Translation FAQs
Answers to common questions about IB scope, Reference Safety Information, amendments, protocol alignment, reviewer workflows, and long-term multilingual version management.
Investigator’s Brochure translation is the specialized translation of the clinical, nonclinical, pharmacology, safety, dosing, and investigational product information contained in an IB for multilingual clinical development. Because the document brings together multiple scientific disciplines and evolves over time, quality also depends on terminology consistency, numerical accuracy, internal relationships, document structure, and version control.
Sesen can translate complete Investigator’s Brochures as well as selected sections, revised content, appendices, tables, figures, safety information, Reference Safety Information, and subsequent editions. Scope can include summaries, product information, nonclinical studies, clinical experience, pharmacology, PK/PD, dosing and administration information, references, and other sponsor-provided source content.
Yes. Sesen translates approved Reference Safety Information and related safety terminology within Investigator’s Brochures and can maintain that terminology through subsequent multilingual updates. Expectedness, causality, medical evaluation, reportability, and other safety or regulatory determinations remain with the sponsor and responsible medical, pharmacovigilance, and regulatory teams.
Sesen can compare the new source edition with the previous version, identify changed content, translate affected sections, reuse approved terminology and translation memory where appropriate, perform linguistic and version-change QA, update formatting, and coordinate required target-language releases.
Yes. When relevant approved reference documents are available, Sesen can use protocol terminology, sponsor glossaries, previous translations, study-specific terminology, translation memories, and other authorized references to help maintain consistency between the Investigator’s Brochure, protocol, and related clinical documentation.
Yes. Authorized sponsor, medical, scientific, regulatory, CRO, or in-country reviewer feedback can be incorporated into the appropriate target-language versions. Approved terminology decisions and reviewer preferences can also be captured for reuse in subsequent IB editions and related clinical documentation.
Not necessarily. The appropriate verification approach depends on the sponsor’s requirements, study procedures, target market, document use, and agreed quality plan. Sesen can incorporate additional review methodologies when requested, while the core IB workflow can emphasize specialized forward translation, independent linguistic review, terminology control, document-level QA, version control, and final human quality checks.
Yes. Sesen can support ongoing IB programs in which the source document is revised as clinical, nonclinical, safety, dosing, or product information changes. Translation memories, approved terminology, prior language versions, reviewer decisions, and controlled source comparisons help maintain continuity from one edition to the next.
Keep Your Investigator’s Brochure Consistent Across Languages and Versions
Whether you are preparing the first multilingual IB, adding new countries, updating Reference Safety Information, incorporating new clinical evidence, or coordinating the next edition across multiple languages, Sesen can build a controlled translation workflow around your program.