Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.
Why Accurate Preclinical Translation Matters in Biotechnology
Accurate translation of preclinical research documents is critical for advancing drug development, enabling cross-border scientific collaboration, and meeting global regulatory expectations. From toxicology studies and pharmacokinetic reports to investigator brochures and laboratory protocols, every data point must be translated with scientific precision to support informed decision-making in early-stage R&D.
As biotechnology companies and contract research organizations (CROs) expand into international markets, the demand for linguistically accurate and technically sound translations has never been greater. Preclinical translation errors can lead to delays in Investigational New Drug (IND) or Clinical Trial Application (CTA) submissions, misinterpretation of data, and compromised intellectual property (IP) protection.
At Sesen, we specialize exclusively in life sciences translation. Our team of professional native translators with scientific backgrounds delivers high-quality, regulatory-compliant translations across 150+ languages. Leveraging deep subject matter expertise in biotechnology and molecular research, we help clients streamline global preclinical workflows and accelerate time to first-in-human studies.
Read More Read Less
Types of Preclinical Documents We Translate
Sesen provides expert translation services for a wide range of preclinical research materials to support global drug development, regulatory filings, and scientific collaboration. Our linguists combine advanced language skills with deep subject matter expertise in biotechnology, pharmacology, and molecular biology to ensure clarity, accuracy, and compliance in every translation.
We translate the following preclinical research documents:
Preclinical Study Protocols
Detailed study designs and methodologies for in vivo and in vitro research, translated to meet GLP and ICH standards.
Investigator Brochures
Comprehensive overviews of investigational products, including pharmacological data, toxicology, and safety profiles.
Nonclinical Study Reports
Full reports covering toxicology, pharmacokinetics (PK), and pharmacodynamics (PD), prepared for inclusion in IND and CTA submissions.
In Vivo and In Vitro Research Documentation
Experimental data, results, and analytical methods from early-stage laboratory studies.
Laboratory Notebooks and Technical Data Sheets
Handwritten records, observations, and raw data translated with precision to maintain scientific integrity.
Genetic and Molecular Biology Research Documents
Content related to gene expression studies, CRISPR/Cas9 protocols, sequencing results, and recombinant technologies.
Safety Pharmacology and ADME Studies
Translation of absorption, distribution, metabolism, and excretion (ADME) documentation and safety pharmacology assessments.
Preclinical Sections of IND/CTA Submissions
Regulatory-ready translations aligned with FDA, EMA, PMDA, and NMPA requirements for clinical trial applications.
Internal Research Memos and Cross-Functional Reports
Internal communication between R&D, regulatory, and clinical teams requiring accurate and consistent translation across departments.
Sesen ensures all translations are performed by professional native linguists with a scientific background, backed by robust QA processes and regulatory knowledge to support seamless global preclinical operations.
Linguistic and Scientific Expertise You Can Trust
At Sesen, we understand that preclinical research translation demands more than just language proficiency—it requires deep scientific knowledge and domain-specific expertise. That’s why all our translators are professional native linguists with advanced degrees in the life sciences, including PhDs, PharmDs, and MScs in fields such as molecular biology, biotechnology, pharmacology, and toxicology.
Our team is uniquely qualified to translate complex scientific content with accuracy, fluency, and regulatory awareness. We ensure consistent use of scientific nomenclature, Latin-based terminology, and standardized chemical compound naming conventions in every document. Whether translating highly technical study protocols or data-heavy toxicology reports, our experts maintain the scientific integrity of your content across languages.
By combining linguistic precision with subject matter expertise, Sesen helps life sciences organizations communicate preclinical findings effectively on a global scale—supporting international research collaboration, accelerating regulatory submissions, and safeguarding the credibility of early-stage drug development data.
Read More Read Less
Regulatory Alignment Across Global Markets
Sesen’s preclinical research translation services are designed to meet the strict regulatory and compliance standards of global health authorities, ensuring your documentation is ready for submission without delay. Our linguists are trained to translate technical content with full alignment to the expectations of leading regulatory bodies, including the FDA (U.S.), EMA (Europe), PMDA (Japan), and NMPA (China).
We translate preclinical data in accordance with internationally recognized standards such as ICH M3 (nonclinical safety studies), OECD GLP (Good Laboratory Practice), and SEND (Standard for Exchange of Nonclinical Data), maintaining the scientific and structural integrity of your original documents.
Whether you’re preparing Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), or other regulatory submissions, Sesen delivers precise, compliant translations that facilitate faster approvals and reduce the risk of rework or regulatory pushback. Our team ensures technical terminology, tabulated data, and study summaries are rendered accurately and consistently across all target languages.
By integrating regulatory insight into every stage of the translation process, we help life sciences clients accelerate global product development while meeting the highest standards of quality and compliance.
Read More Read Less
Human Expertise Powered by Smart Translation Technology
At Sesen, we combine deep scientific expertise with cutting-edge translation technology to deliver accurate, scalable solutions for preclinical research. Our secure, cloud-based translation management system (TMS)—hosted on Amazon Web Services (AWS)—ensures end-to-end data security, version control, and streamlined collaboration across multilingual teams.
For internal-use-only documents, we offer machine translation post-editing (MTPE) to accelerate turnaround times while preserving technical accuracy through expert human revision. We also integrate client-specific termbases, glossaries, and style guides to ensure consistent, on-brand language across all content types.
Sesen supports content reuse and modular submission workflows, helping biotechnology firms and CROs reduce redundancy, improve submission efficiency, and maintain alignment across preclinical and regulatory documentation.
By blending smart technology with experienced human linguists, we help life sciences organizations scale their global research operations—without compromising scientific integrity or compliance.
Read More Read Less
Rigorous Quality Assurance for Scientifically Accurate Translation
At Sesen, quality is central to our preclinical research translation services. We follow a multi-step quality assurance (QA) workflow that ensures every document meets the highest standards of scientific accuracy, linguistic clarity, and regulatory compliance. Each project undergoes a structured process that includes initial translation by a subject-matter expert, independent revision, in-house QA review, and optional client feedback cycles.
For high-impact preclinical documents—such as nonclinical study reports or regulatory submission materials—we provide in-context linguistic validation, reviewing content in its final layout or platform environment to ensure accuracy, readability, and technical consistency.
We also leverage translation memories (TMs) and advanced QA tools to maintain uniform terminology, flag inconsistencies, and improve efficiency across projects. Client-specific glossaries and style guides are integrated into every workflow to support consistent communication across departments and submissions.
This rigorous approach enables Sesen to deliver life sciences translations that are scientifically sound, regulator-ready, and aligned with your organization’s internal standards.
Read More Read Less
Global Language Coverage for Preclinical Research
Sesen supports translation into 150+ languages, enabling life sciences organizations to communicate preclinical data accurately and compliantly across global markets. Our extensive language capabilities empower biotechnology companies, CROs, and research institutions to collaborate internationally, streamline regulatory submissions, and accelerate early-stage development programs.
We specialize in the most in-demand language pairs for preclinical and biotechnology translation, including:
English to French (EN–FR), Japanese (EN–JA), Chinese (EN–ZH), German (EN–DE), Spanish (EN–ES), and Korean (EN–KO)—as well as reverse translation when required for global filings and scientific correspondence.
All translations are performed by professional native linguists with subject matter expertise in the life sciences, ensuring that complex scientific terminology is rendered clearly and consistently in every target language. Whether you’re preparing an IND for the U.S. FDA, a CTA for the EMA, or submitting to Japan’s PMDA or China’s NMPA, Sesen provides the language support needed to operate with confidence across borders.
Read More Read Less
Confidentiality & Data Security in Preclinical Translation
At Sesen, we understand that preclinical research often involves highly sensitive and proprietary scientific data. That’s why we implement stringent confidentiality protocols and enterprise-grade data security measures across all stages of the translation process.
All projects are protected under non-disclosure agreements (NDAs), and we use secure, access-controlled workflows to safeguard research content from unauthorized access or data leakage. Our operations are certified under ISO 17100 (translation services), ISO 9001:2015 (quality management), and ISO 13485:2016 (medical devices quality)—ensuring full compliance with industry best practices and international regulatory expectations.
We deploy role-based access controls, two-factor authentication (2FA), and encrypted data transmission through our cloud-based translation management system hosted on AWS, enabling secure collaboration across global teams while maintaining full traceability and audit readiness.
With Sesen, life sciences organizations can trust that their preclinical documents are handled with the highest level of integrity, security, and regulatory alignment—every time.
Read More Read Less
Why Leading Biotech Teams Choose Sesen for Preclinical Translation
Sesen is a trusted partner for life sciences organizations seeking accurate, compliant, and industry-specialized translation services. Unlike general language service providers, we focus exclusively on the life sciences, with deep expertise in biotechnology and early-phase drug development. This sector-specific focus allows us to deliver translations that are not only linguistically accurate but also scientifically and regulatorily aligned.
Our team includes professional native-language linguists with advanced degrees in relevant scientific fields, supported by dedicated project managers who understand the complexities of preclinical workflows and submission timelines. Every project is managed with a high degree of responsiveness, transparency, and technical rigor.
We have a proven track record delivering preclinical translation services for global biotech startups, CROs, and pharmaceutical sponsors, helping clients accelerate international collaboration and meet the documentation requirements of global regulatory authorities.
Whether you're preparing for IND/CTA submissions, translating early-stage research reports, or coordinating multi-language studies, Sesen offers the precision, scalability, and domain knowledge you need to move forward with confidence.
Read More Read Less