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Why Translate CTAs and Site Contracts

Why Translate CTAs and Site Contracts?

Clinical Trial Agreements (CTAs) and site contracts are foundational legal documents that govern the relationship between sponsors, contract research organizations (CROs), and clinical trial sites. These agreements outline responsibilities, payment terms, indemnification clauses, confidentiality provisions, and regulatory obligations. When clinical studies are conducted across international sites, translating these documents into the local language is essential for legal validity, regulatory compliance, and operational clarity.

Failure to provide accurate translations can result in serious risks, including regulatory rejection, contractual disputes, trial delays, and potential litigation. Local ethics committees and regulatory authorities often require translated versions of CTAs as part of their review process. Additionally, site personnel must clearly understand their contractual obligations in their native language to avoid misinterpretation and ensure compliance.

Sesen specializes in translating clinical trial legal agreements with precision and consistency. Our linguists combine legal and clinical subject matter expertise to produce enforceable, country-specific translations aligned with local legal frameworks and international regulatory standards. Whether you are launching a single-site trial or a global Phase III study, Sesen delivers trusted translations that support clear communication and mitigate legal and compliance risks.

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Types of Legal Agreements We Translate

Sesen provides expert translation services for a wide range of clinical trial legal documents to support global study execution and local regulatory compliance. We translate legally binding contracts with precision, ensuring legal terminology, clause intent, and jurisdiction-specific language are accurately rendered for each target country and language.

Our legal translation coverage includes:

Master agreements between sponsors or CROs and trial sites that define roles, responsibilities, compliance requirements, and liability terms.

Contracts detailing pre-study requirements, training obligations, and readiness criteria for investigational site activation.

Legal documents protecting proprietary trial information, protocols, and sponsor data shared with investigators, institutions, and vendors.

Contracts between trial sponsors and principal investigators outlining duties, reporting obligations, and protocol adherence.

Agreements involving third-party labs, imaging vendors, and logistics providers supporting trial operations under sponsor oversight.

Localized contract modifications that reflect regional regulatory requirements, language laws, and ethics committee feedback.

Translations of key sections that address subject protection, adverse event liability, and sponsor responsibilities.

Detailed breakdowns of site compensation, milestone-based payments, and currency-specific financial obligations.

All translations are conducted by legal linguists with expertise in clinical trial law and local regulatory expectations. Our approach ensures every translated contract is legally enforceable, culturally appropriate, and aligned with international standards such as ICH-GCP, EMA, and FDA guidelines.

Legal Translation Requirements in Clinical Trials

Accurate legal translation is a regulatory requirement for conducting multinational clinical trials. Local Institutional Review Boards (IRBs) and Ethics Committees (ECs) often require translated Clinical Trial Agreements (CTAs), site contracts, and related legal documents as part of their protocol approval process. These translations must meet both linguistic accuracy and legal enforceability standards within the jurisdiction where the trial is conducted.

Many countries mandate the submission of translated legal documents to national regulatory agencies such as ANSM in France, PEI in Germany, and PMDA in Japan. Inaccurate or incomplete translations can lead to delays in study startup, contract renegotiation, or rejection by ethics and regulatory authorities.

Effective legal translation in clinical trials requires legal equivalency, not word-for-word conversion. Clauses must reflect the same legal intent and obligations across languages and legal systems. This is especially critical when translating liability, indemnification, and subject protection terms, which can differ significantly between civil law and common law jurisdictions.

In some countries, certified or sworn translators are legally required for translating official agreements. Sesen works with qualified legal linguists and sworn translators where applicable to ensure compliance with local law and regulatory expectations. Our team integrates legal subject matter expertise with life sciences knowledge to deliver translations that support smooth regulatory submission, enforceable contracts, and successful trial execution.

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Our Translation Process for Legal Agreements

Our Translation Process for Legal Agreements

Sesen applies a rigorous and proven workflow to deliver accurate, enforceable translations of Clinical Trial Agreements (CTAs), site contracts, and related legal documents. Our process is designed to minimize legal risk, support regulatory compliance, and ensure mutual understanding between trial sponsors and global stakeholders.

We begin by reviewing the source files to assess legal complexity, country-specific requirements, and project scope. This includes identifying critical legal clauses, jurisdictional nuances, and any pre-approved templates provided by the sponsor or CRO.

Only experienced legal translators with clinical trial expertise are assigned to each project. Our linguists possess deep knowledge of contract law and medical research regulations in the target country, ensuring accuracy and contextual relevance.

Each document undergoes a primary legal translation followed by an independent legal review by a second expert. This dual-phase approach reduces the risk of legal misinterpretation and reinforces clause consistency across multilingual versions.

We align legal terms with the sponsor’s global templates, master service agreements, and preferred terminology. Our team uses legal glossaries, reference contracts, and jurisdiction-specific clause libraries to ensure consistency and compliance.

Our QA process includes linguistic validation and optional back-translation for high-risk agreements or regions that require additional verification. All translations are reviewed for accuracy, completeness, and alignment with regulatory expectations.

For added assurance, we offer in-country legal review services in partnership with local counsel. This step helps confirm legal enforceability and acceptance by local authorities and ethics committees.

Sesen’s legal translation process is ISO 17100 certified and trusted by life sciences sponsors, CROs, and legal teams worldwide for precise and reliable multilingual contract localization.

Why Choose Sesen for CTA & Site Contract Translation

Sesen is a trusted partner for the precise translation of Clinical Trial Agreements (CTAs), site contracts, and related legal documentation. Our specialized approach combines legal and clinical expertise to help sponsors and CROs navigate the complexities of global clinical research with confidence.

Unlike general language providers, Sesen works exclusively in the life sciences sector. This singular focus ensures that our translation workflows are fully aligned with the regulatory, legal, and operational demands of clinical trials.

Our legal translators are not only native professionals but also subject matter experts in contract law and clinical trial operations. They understand the legal implications of indemnity clauses, payment terms, subject protection, and regulatory compliance in the context of global research.

We maintain a vetted network of legal linguists across 150 languages. Each translator is carefully selected based on legal specialization, language fluency, and in-country knowledge to ensure cultural appropriateness and legal accuracy.

Our translation processes are certified under ISO 17100 for translation quality and ISO 9001:2015 for quality management systems. These standards reflect our commitment to consistency, accountability, and continuous improvement.

We follow strict data privacy protocols, including NDA execution, secure file transfer systems, and access-controlled workflows to protect sensitive contract and clinical data throughout the translation process.

Sesen offers adaptable delivery models to meet the unique needs of global clinical studies. We support rush translations, country-by-country delivery schedules, and rolling handoffs aligned with trial startup timelines.

With Sesen, sponsors and CROs gain a dedicated translation partner that understands both the legal and scientific dimensions of clinical research. Our services are designed to help reduce regulatory risk, accelerate startup, and ensure legal clarity across all trial markets.

Languages and Markets We Support

Languages and Markets We Support

Sesen provides legal translation services for Clinical Trial Agreements (CTAs) and site contracts in over 150 languages, supporting global clinical trial operations across every major research region. Our network of professional native legal translators enables seamless communication and contractual alignment between sponsors and investigative sites worldwide.

We have extensive experience translating legal documentation for regulatory and ethics review in the following regions:

Legal content tailored to national regulations, GDPR compliance, and country-specific ethics board requirements across all EU member states.

Spanish and Portuguese translations adapted to legal systems in Argentina, Brazil, Mexico, Colombia, Chile, and other key LATAM markets, including support for notarization and sworn translation when required.

Legal translations localized for Japan, South Korea, China, India, Australia, and Southeast Asian countries, with expertise in jurisdictional requirements from PMDA, CDSCO, NMPA, and local health authorities.

Arabic and French translations for legal agreements in countries such as the UAE, Egypt, Saudi Arabia, and Morocco, ensuring alignment with local civil codes and healthcare regulations.

We support the translation of single-language agreements as well as the harmonization of multilingual CTAs across diverse jurisdictions. Our team ensures that all translated versions reflect consistent legal meaning and maintain enforceability across civil law and common law systems. Whether your trial is centralized or regionally segmented, Sesen delivers contract translations that meet the linguistic, regulatory, and cultural expectations of each local market.

Common Challenges and How Sesen Solves Them

Common Challenges and How Sesen Solves Them

Translating Clinical Trial Agreements (CTAs) and site contracts for global studies presents a range of legal and linguistic challenges. Sesen addresses these complexities with precision, helping sponsors and CROs avoid costly delays, miscommunication, and compliance risks.

Global clinical trials involve jurisdictions governed by either civil law or common law systems, each with distinct legal structures and interpretive norms. Sesen ensures legal equivalency by selecting translators with jurisdiction-specific legal expertise who can preserve contract intent while adapting language to local legal frameworks.

Legal phrases, clause structures, and enforceability standards differ significantly between countries. Our legal linguists are trained to localize terminology and flag clauses that may require restructuring or legal review to meet national expectations and ethics committee requirements.

Accurate translation of financial terms, including local currencies, tax obligations, and milestone-based payment schedules, is critical to ensure contract transparency and site compliance. Sesen localizes all budget-related content with attention to regional accounting norms and financial terminology.

Indemnification, insurance, and liability language must be translated with exceptional precision. A single error or inconsistency between source and target versions can expose sponsors to legal disputes. Sesen applies a dual-review process and, when required, back-translation or legal verification to safeguard clause integrity across all languages.

By combining legal subject matter expertise with proven translation workflows, Sesen helps life sciences organizations overcome these challenges and deliver multilingual contracts that are clear, compliant, and enforceable.

Related Services

Sesen offers a full suite of clinical trial translation services to support end-to-end study execution across global markets. Our integrated approach ensures consistency, accuracy, and regulatory compliance across all clinical documentation.

  • Comprehensive language support for all phases of global clinical research, including patient-facing materials, regulatory submissions, study protocols, and investigator communications.
  • Accurate and culturally sensitive translations of ICFs that meet the readability and regulatory requirements of ethics committees and patient populations in over 150 languages.
  • Ethics Committee Submission Packages
    Translation of submission documents required by local IRBs and ethics committees, including cover letters, study summaries, and sponsor statements.
  • Precise translation of Investigator Brochures to support clinical site engagement and regulatory review, with focus on scientific clarity and terminology consistency.
  • Localization of clinical protocols and subsequent amendments to ensure alignment with evolving regulatory requirements and site-specific implementation needs.
  • eTMF Document Translation
    Translation of Trial Master File content, including contracts, agreements, reports, and correspondence, for complete and compliant study documentation across all trial sites.
  • Specialized translation of product labeling to meet local regulatory authority guidelines and support submission of investigational or marketed products.

Sesen’s coordinated legal and clinical translation workflows ensure that all trial documents work together seamlessly across languages and jurisdictions. This supports faster startup, improved regulatory outcomes, and reduced compliance risk for your global studies.

Case Study: CTA Translation for a Multi-Country Phase III Oncology Trial

A global biopharmaceutical sponsor engaged Sesen to support the legal translation of Clinical Trial Agreements (CTAs) and site contracts for a Phase III oncology study spanning eight countries across Europe, Asia-Pacific, and Latin America. The trial involved over 60 investigative sites and required translation of highly complex legal documents into 10 target languages, including German, French, Spanish, Japanese, Korean, and Portuguese.

The project demanded accurate localization of legal clauses governing subject liability, indemnification, budget terms, and data privacy in compliance with country-specific regulatory requirements such as GDPR, PMDA guidelines, and ANVISA standards. Each translated version needed to be aligned with the sponsor’s global CTA template while conforming to the local legal frameworks of both civil and common law jurisdictions.

Sesen deployed a team of legal subject matter expert translators and regional language reviewers to ensure enforceability, consistency, and cultural relevance. Translations were delivered in a rolling format to support site activation timelines in each market, with the entire project completed within a four-week turnaround.

By combining legal precision with deep clinical and regulatory knowledge, Sesen enabled the sponsor to accelerate study startup, reduce contract risk, and maintain compliance across multiple trial markets.

For more examples of our end-to-end support, visit our Clinical Trial Translation Services page.

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Frequently Asked Questions

In some jurisdictions, translated Clinical Trial Agreements must be certified or notarized to be legally recognized by regulatory authorities or ethics committees. Requirements vary by country. Sesen works with certified and sworn translators where needed to ensure compliance with local laws.

Countries such as France, Germany, Japan, Brazil, and China typically require CTAs and site contracts to be translated into the local language for ethics submission and regulatory approval. Sesen provides region-specific guidance to help sponsors navigate these requirements.

Yes. Sesen specializes in harmonizing multilingual CTAs to maintain legal consistency across jurisdictions while adapting clauses for local enforceability. Our legal linguists align translations with the sponsor’s global template and local legal standards to minimize risk and ensure contract clarity.

Sesen offers optional in-country legal counsel review for added assurance. We also conduct legal linguistic review by subject matter experts to ensure clause intent and terminology accuracy. This service is particularly valuable for high-risk clauses such as indemnification and liability.

Turnaround time depends on language volume, document complexity, and the number of target languages. For single-language CTAs, our standard delivery is 3 to 5 business days. Expedited or rolling deliveries are available for urgent or multi-country projects.

Have more questions? Contact our legal translation experts to discuss your specific project needs.

Let’s Talk About Your Legal Translation Needs

Planning a global clinical trial? Sesen is ready to support your CTA and site contract translation requirements with accuracy, speed, and legal precision. Whether you need a single-language agreement or a multi-country rollout, our legal and clinical experts are here to help.

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