How to Choose the Right Language Service Provider for Clinical Trials

Conducting clinical trials across multiple countries requires more than regulatory planning and site coordination. Accurate, timely, and compliant translation is essential to ensure patient safety, data integrity, and ethical oversight. From Informed Consent Forms (ICFs) and site agreements to patient diaries and electronic Clinical Outcome Assessments (eCOA/ePRO), every document must be linguistically precise and culturally adapted for global use. Choosing the right language service provider (LSP) directly impacts the success and regulatory acceptance of your trial.

At Sesen, we specialize exclusively in life sciences translation, supporting sponsors, CROs, and trial sites with expert linguistic services that meet global compliance standards and streamline execution. Our clinical trial translation services cover every phase of your global study, from patient-facing materials to regulatory documentation.

The Role of Language Services in Global Clinical Trials

Language services are a foundational component of successful global clinical trials. As studies expand across regions, multilingual communication becomes critical to maintaining patient safety, ethical transparency, and regulatory compliance. Sponsors and CROs must ensure that all stakeholders, including patients, investigators, and regulatory authorities, receive accurate, understandable, and culturally appropriate information in their native language.

Key clinical trial documents that require high-quality translation include:

• Informed Consent Forms (ICFs): Must be accurately translated to support patient understanding and ethical approval by institutional review boards (IRBs) and ethics committees.
• Protocols and Investigator Brochures: Provide study objectives, design, and safety information to research teams and must be consistent across languages.
• eCOA/ePRO and Patient Diaries: Require linguistic validation to ensure conceptual equivalence and data reliability across patient populations.
• Site Contracts and Financial Disclosure Forms: Need clear, local-language translations to comply with regional regulatory and legal requirements.
• Safety Letters, SUSARs, and AE/SAE Reports: Must be translated quickly and accurately to support timely regulatory submissions and ongoing pharmacovigilance.

Health authorities such as the FDA, EMA, PMDA, and NMPA expect translated materials to meet the same standards of accuracy and compliance as the original documents. Poor translation can result in regulatory delays, patient risk, and compromised data quality. Working with a language service provider that specializes in clinical research ensures that your multilingual materials align with global submission standards and facilitate successful trial outcomes.

Key Qualities of a Clinical Trial Language Service Provider

Selecting the right language service provider (LSP) is critical to ensuring translation accuracy, regulatory alignment, and smooth clinical trial execution. Life sciences translations require more than linguistic fluency—they demand subject matter expertise, validated processes, and a deep understanding of global compliance frameworks. Below are the essential qualities to look for in a clinical trial LSP:

Life Sciences Specialization

An effective provider must have proven experience in translating content specific to pharmaceuticals, biotechnology, and medical devices. This includes a solid grasp of therapeutic areas, clinical terminology, and the ability to maintain scientific accuracy across patient-facing and regulatory materials.

Regulatory and Compliance Expertise

Clinical trial documentation must meet the expectations of regulatory agencies such as the FDA, EMA, PMDA, and NMPA. An experienced LSP will understand submission protocols, labeling requirements, and documentation standards specific to each region.

ISO 17100 and ISO 9001 Certifications

Certified quality management systems indicate a provider’s commitment to standardized workflows, linguistic accuracy, and continuous improvement. ISO 17100 ensures that translation processes meet professional standards, while ISO 9001 supports overall operational excellence.

Security and Data Privacy Protocols

Protecting sensitive clinical data is non-negotiable. A qualified LSP will follow strict data security measures and demonstrate compliance with HIPAA, GDPR, and 21 CFR Part 11. This includes secure file handling, controlled access, and validated technology platforms to support confidentiality throughout the project lifecycle.

Process Rigor: From Translation to Linguistic Validation

A high-quality language service provider must follow a structured, multi-step process to ensure translations are accurate, consistent, and compliant across all clinical trial materials. From initial translation to final delivery, each step should be aligned with regulatory expectations and audit-readiness standards.

Initial Translation by Qualified Medical Translators

The process begins with professional linguists who are native speakers of the target language and have demonstrated expertise in clinical research. These translators understand therapeutic terminology, regulatory nuances, and the critical need for linguistic precision in patient-facing and regulatory documents.

Linguistic Validation for PROs and eCOA

For Patient-Reported Outcomes (PROs) and electronic Clinical Outcome Assessments (eCOA), linguistic validation is essential to preserve data reliability across languages. This includes:

• Cognitive debriefing to confirm patient comprehension
• Back translation to ensure conceptual equivalence
• Harmonization to resolve discrepancies across versions

These steps are especially important in multi-country trials where consistent patient response is critical.

In-Country Review and Affiliate Feedback Integration

Local regulatory teams and affiliates often play a key role in reviewing translations. A robust process must allow for in-country feedback and provide mechanisms for capturing comments, resolving conflicts, and documenting final approvals.

Reconciliation and Final Formatting

Following review, all edits must be reconciled to produce a finalized version. This includes multilingual desktop publishing (DTP) to ensure translated content retains the original formatting, structure, and layout, especially for complex documents like ICFs.

Validated Workflows Supporting Audit Readiness

The entire process should follow a validated workflow with full traceability, version control, and secure document handling. This ensures that the translation lifecycle can withstand regulatory scrutiny and supports consistent documentation in trial master files (TMF) and electronic systems.

Technology Enablement and Innovation

Modern clinical trials demand scalable, tech-enabled translation workflows that support speed, consistency, and compliance. A qualified language service provider should offer seamless technology integration and innovative solutions that enhance efficiency without compromising quality or regulatory integrity.

Integration with eTMF and CTMS Platforms

A capable provider integrates directly with electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) platforms to streamline document delivery, version control, and audit tracking. This reduces manual errors and accelerates timelines while ensuring alignment with sponsor systems.

Support for eCOA and ePRO Platforms

Translations for electronic Clinical Outcome Assessments (eCOA) and electronic Patient-Reported Outcomes (ePRO) must be platform-compatible. Leading LSPs support Medidata, Veeva, TrialMaster, and other digital tools, ensuring that localized content functions accurately across multilingual user interfaces.

Translation Memory and Terminology Management

By using Translation Memory (TM) and centralized terminology databases, language providers maintain consistency across study phases, documents, and languages. These tools improve quality, reduce cost, and shorten turnaround times, particularly in large-scale or long-term studies.

Machine Translation Post-Editing (MTPE) with Human Oversight

For select content types, MTPE can increase efficiency when guided by skilled medical linguists. Human review ensures that translations meet clinical and regulatory accuracy standards, especially for non-patient-facing materials or repetitive text.

SesenGPT for AI-Enhanced Language Services

Sesen uses proprietary AI tools like SesenGPT to automate glossary extraction, perform quality validation checks, and manage high-volume multilingual content efficiently. These innovations reduce turnaround time, improve consistency, and minimize risk—while ensuring human linguists remain fully in control of final deliverables. Learn more about our approach to AI-powered clinical trial translation and how it supports faster, audit-ready outcomes at scale.

Operational Agility and Project Management

Efficient project management is critical to the success of clinical trial translations. Delays, miscommunications, or inconsistent updates can impact patient safety, site compliance, and regulatory timelines. A capable language service provider must offer operational agility, backed by experienced personnel and scalable workflows.

Dedicated Life Sciences Project Managers

Experienced project managers with clinical trial expertise oversee the entire translation process, from initial intake to final delivery. They understand study timelines, protocol requirements, and document dependencies, ensuring that each task is completed with accuracy and efficiency.

Around-the-Clock Availability

Urgent updates, such as safety letter translations or last-minute protocol amendments, require immediate attention. A responsive provider offers 24/7 availability to accommodate global time zones and support resubmissions without delay.

Global Linguist Network Covering 150+ Languages

A robust network of professional linguists enables rapid resource allocation for any language combination. This is especially important in multi-country trials where consistency, speed, and subject matter expertise must align across regions.

Version Control and Change Tracking

Ongoing studies often involve multiple revisions to key documents, such as Informed Consent Forms (ICFs). Effective version control systems and change-tracking mechanisms help ensure that updates are implemented accurately, reviewed in context, and documented for audit readiness. Sesen supports efficient modular submission strategies that reduce rework during updates to ICFs, protocols, and translated documentation across global sites.

Regional and Cultural Competence

Effective clinical trial translations require more than linguistic accuracy. They must reflect regional context, cultural nuances, and regulatory expectations specific to each trial location. A language service provider with strong regional and cultural competence helps ensure that content is not only understood but also accepted by local stakeholders.

In-Country Linguists with Local Expertise

Using professional linguists who live and work in the target region is essential for cultural adaptation. These in-country experts understand local expressions, idiomatic language, and patient expectations, which improves clarity and reduces the risk of misinterpretation in sensitive documents such as informed consent forms.

Familiarity with Local IRB and Ethics Committee Requirements

Each country has unique standards for clinical trial documentation. A knowledgeable provider anticipates the preferences of local institutional review boards (IRBs) and ethics committees (ECs), helping reduce back-and-forth revisions and accelerate approval timelines.

Handling Dialectal and Regional Language Differences

Languages such as Spanish, Portuguese, and Arabic vary significantly by region. Translating into Brazilian Portuguese instead of European Portuguese, or adapting for Latin American Spanish instead of Castilian, is not just a matter of tone, it can impact comprehension and regulatory approval. The right provider proactively identifies these differences and assigns the appropriate linguistic resources from the start.

Cost Transparency and Scalability

Managing translation costs across the lifecycle of a clinical trial requires clear pricing models and the ability to scale with study demands. A reliable language service provider offers transparent, flexible pricing and operational capacity that supports trials of all sizes, from early phase to multinational Phase III studies.

Clear Pricing Structures

Understanding how services are billed is essential for accurate budgeting. Most translation services are priced on a per-word basis, while validation services such as cognitive debriefing or back translation are typically billed hourly. A trustworthy provider will offer upfront estimates, outline scope clearly, and avoid unexpected charges.

Discounts for Large and Multi-Site Trials

For sponsors conducting high-volume or multi-country studies, volume-based discounts can lead to significant cost savings. A mature LSP will have pricing models that reward scale while maintaining consistency in quality and turnaround times.

Scalable Support for All Phases of Clinical Trials

Whether the study is a small Phase I trial or a complex, global Phase III program, the provider should have the infrastructure, linguist capacity, and workflow flexibility to match the scale of operations. This includes handling multiple languages, staggered timelines, and large document sets without compromising accuracy or delivery speed.

Red Flags to Avoid

Selecting the wrong language service provider can introduce compliance risks, delay timelines, and compromise the quality of your clinical trial documentation. Below are key warning signs that may indicate a provider is not equipped to handle clinical research translation requirements.

Limited Regulatory or Life Sciences Expertise

Generalist translation agencies may lack the in-depth knowledge needed to navigate complex clinical trial regulations. Without familiarity with FDA, EMA, PMDA, or NMPA expectations, these providers risk producing content that fails to meet regional submission standards.

Weak Technology Infrastructure

A provider without robust translation management systems, automated QA checks, or integration capabilities may struggle to deliver consistent, efficient, and scalable results. Limited use of Translation Memory, terminology management, or secure file handling can hinder both quality and productivity, especially for large or multi-phase trials.

Inadequate Responsiveness and Workflow Flexibility

Timely updates are essential during active studies, especially when protocol amendments, safety letters, or urgent regulatory changes arise. If a provider cannot accommodate time-sensitive requests or respond to affiliate feedback promptly, it can stall progress and jeopardize compliance.

Lack of Validated Workflows and Audit Trails

Clinical documentation must be traceable, reviewable, and auditable. A provider without a validated workflow, change tracking, or version control may struggle to meet the documentation standards required for inspections or trial master file (TMF) completeness.

Questions to Ask Before Choosing a Partner

Before selecting a language service provider for your clinical trial, it is essential to evaluate their qualifications, processes, and ability to support regulatory and operational requirements. The following questions will help uncover whether a provider has the necessary expertise to meet your needs and deliver audit-ready translations at every stage of the study.

What experience do you have with my specific therapeutic area?

Therapeutic knowledge plays a key role in clinical accuracy. Ask whether the provider has translated content in your therapeutic domain and whether they assign linguists with relevant subject matter expertise to your project.

Can you walk me through your process for linguistic validation?

For Patient-Reported Outcomes (PROs), eCOA, and other patient-facing materials, linguistic validation ensures conceptual equivalence across languages. A qualified provider should be able to explain each step of the process, including cognitive debriefing, reconciliation, and harmonization.

How do you handle back translation and reconciliation?

Back translation is critical for validating the accuracy and intent of sensitive materials like informed consent forms. Ask how the provider manages the process, resolves discrepancies, and incorporates sponsor or reviewer feedback into final deliverables.

How do you manage affiliate or in-country review feedback?

Effective integration of local feedback is essential for timely approvals. Clarify how the provider collects, tracks, and implements comments from country affiliates, regulatory teams, and ethics committees.

Are your translators trained in GCP-compliant terminology?

Translators should be familiar with Good Clinical Practice (GCP) language and regulatory expectations. Confirm that the provider uses trained medical linguists with experience in clinical documentation and the regulatory submission process.

Why Leading Sponsors and CROs Choose Sesen

Sesen is a trusted partner for global clinical trials, offering deep life sciences expertise, validated processes, and cutting-edge technology that support successful regulatory submissions across regions. Our specialized approach combines linguistic precision with operational flexibility, making us a preferred choice for sponsors and CROs seeking high-quality translation solutions.

Therapeutic Expertise Across Complex Areas

We bring proven experience in high-stakes therapeutic areas such as oncology, neurology, rare diseases, and vaccines. Our translators and reviewers are trained in domain-specific terminology, ensuring that your content remains accurate, consistent, and scientifically sound.

ISO-Certified, Audit-Ready Workflows

Sesen’s operations are certified to ISO 17100 and ISO 9001 standards, reflecting our commitment to quality, consistency, and regulatory alignment. Our workflows are fully documented, traceable, and designed to withstand inspection by authorities and ethics committees.

Regulatory Success Across Global Markets

We support sponsors and CROs through all phases of clinical development, including submissions to the FDA, EMA, and PMDA. Our track record includes successful translation support for clinical protocols, ICFs, and safety documentation across a wide range of markets.

Advanced AI and Terminology Management Tools

Sesen uses proprietary tools, including SesenGPT, to accelerate glossary extraction, automate QA checks, and ensure terminological consistency across large studies. Our technology enhances productivity while keeping linguists in full control of output quality.

Human-First Approach Powered by Technology

While we invest in automation and innovation, every deliverable is reviewed by expert linguists who understand the context, audience, and regulatory implications of your content. We do not rely on machine translation for critical patient-facing or regulatory materials.

Seamless Collaboration with All Stakeholders

We work closely with sponsors, CROs, in-country reviewers, and ethics committees to facilitate approvals and reduce review cycles. Our project managers coordinate across time zones to ensure alignment, transparency, and timely communication at every stage.

Let’s Talk About Your Trial Needs

Ready to accelerate your global clinical trial with accurate, compliant translations?
Sesen provides end-to-end language solutions tailored for every trial phase, therapeutic area, and regulatory region. Whether you’re preparing ICFs, submitting to global authorities, or managing multilingual eCOA, our expert team is here to support you.

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