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Project Overview

A leading global Clinical Research Organization (CRO) engaged Sesen to perform comprehensive linguistic validation for a Clinical Outcome Assessment (COA) instrument used in a large-scale oncology clinical trial. The study, sponsored by a major pharmaceutical company, aimed to evaluate the efficacy and patient impact of a new cancer treatment across multiple geographic regions.

The project required the linguistic validation of patient-facing COA materials in 25 target languages to support consistent, high-quality patient-reported data collection. The objective was to ensure conceptual equivalence across all language versions while meeting the rigorous standards of global health authorities, including the FDA, EMA, and PMDA.

Sesen’s role was to deliver validated, culturally adapted translations that preserve the instrument’s intent and sensitivity across diverse patient populations. This work was essential to meet regulatory expectations for COA and PRO (Patient-Reported Outcome) instruments, enhance cross-cultural comparability of trial data, and support the study’s global submission strategy.

By combining linguistic expertise, oncology domain knowledge, and ISO-compliant workflows, Sesen helped the CRO and sponsor accelerate trial readiness and mitigate the risks associated with poor instrument translation or cultural misalignment.

Client Challenge

The client, a global CRO, faced the urgent need to linguistically validate a complex Clinical Outcome Assessment (COA) instrument in 25 languages for use in a multi-country oncology clinical trial. The project required not only accurate translation but also rigorous validation to ensure conceptual equivalence, cultural appropriateness, and regulatory alignment across diverse patient populations.

Each language version had to comply with stringent regulatory standards, including guidelines from the FDA, EMA, PMDA, and other global health authorities. These requirements mandated a structured, multi-step validation process that included forward and back translation, reconciliation, clinician review, and cognitive debriefing with native patients in local markets.

The CRO also faced significant project management challenges. The linguistic validation process demanded high coordination across multiple stakeholders, translators, medical reviewers, project leads, and in-country consultants, all while working under tight deadlines driven by clinical trial startup timelines.

Moreover, the risk of data variability was a key concern. Inconsistent or unclear translations could compromise patient comprehension, skew clinical trial data, and delay regulatory approvals. The CRO needed a trusted language service partner with the domain expertise, workflow control, and linguistic precision required to deliver validated, submission-ready translations at scale and speed.

The Sesen Solution

To meet the client’s regulatory, linguistic, and timeline requirements, Sesen delivered end-to-end linguistic validation services across 25 languages, fully aligned with ISPOR best practices, ISO 17100 standards, and FDA PRO guidance for clinical outcome assessments.

The project followed a rigorous, multi-step validation process designed to ensure conceptual equivalence, patient comprehension, and submission-readiness of the translated COA instruments across all target markets. Key components of the workflow included:

  • Dual forward translations by two independent native-speaking linguists for each target language
  • Reconciliation of the forward translations by lead linguists to produce a single, harmonized version
  • Back translation into English and thorough comparison against the source instrument to verify semantic accuracy
  • Cognitive debriefing interviews conducted with representative patients in each country to test clarity, relevance, and cultural appropriateness
  • Clinician review by local subject matter experts to assess medical accuracy and alignment with clinical intent
  • Final harmonization and proofreading to deliver linguistically and clinically validated instruments ready for regulatory use

All deliverables were processed through Sesen’s centralized quality assurance (QA) framework, ensuring consistency across languages and full traceability of all edits and approvals. The project was managed using validated workflows and documentation protocols, meeting the CRO’s internal SOPs and external regulatory expectations.

Sesen assigned native, in-country linguists with specialized expertise in oncology and COA translation to each language pair. A dedicated project team managed cross-functional collaboration using a secure, cloud-based platform that enabled real-time file sharing, version control, and stakeholder input at every stage.

This integrated approach allowed Sesen to deliver high-quality, patient-tested, and regulator-ready COA translations on schedule, supporting the successful global rollout of the oncology clinical trial.

Languages and Regions Covered

Sesen provided linguistic validation in 25 languages across key clinical trial regions, including North America, South America, Europe, Asia, and the Middle East. The scope of work spanned both widely spoken global languages and region-specific dialects to support diverse patient populations participating in the oncology study.

Languages included:
Spanish (Spain and Latin America), French, German, Italian, Portuguese (Brazil and EU), Chinese (Simplified and Traditional), Japanese, Korean, Russian, Arabic, Hindi, and others. Each translation accounted for regional linguistic variants, medical terminology alignment, and cultural adaptation to ensure consistency and clarity.

Sesen applied tailored strategies for health literacy adaptation, prioritizing terminology that was both medically accurate and easily understood by patients with varying levels of education and clinical familiarity. Linguists incorporated country-specific norms, idiomatic expressions, and regulatory expectations to maintain conceptual equivalence while improving real-world usability.

By localizing content beyond direct translation, Sesen helped ensure that each COA instrument version was culturally relevant, linguistically validated, and ready for deployment in the trial’s target countries, contributing to the collection of high-integrity patient-reported outcomes.

Validated COA Delivery for Global Trials

Sesen successfully delivered 25 fully validated translations of the Clinical Outcome Assessment (COA) instrument, meeting the project’s global scope and accelerated timeline. Each translation adhered to stringent regulatory requirements and was documented in compliance with the CRO’s internal SOPs and sponsor-specific quality standards.

The validated instruments supported faster regulatory submissions, including to the FDA and EMA, and enabled efficient patient onboarding at clinical trial sites worldwide. By ensuring conceptual equivalence and cultural relevance across all language versions, Sesen helped preserve the scientific validity of the COA tool and strengthened the reliability of patient-reported outcomes across regions.

The client reported improved cross-functional coordination, reduced back-and-forth during review cycles, and greater confidence in the linguistic quality of the submission package. The success of the project led to an expanded partnership, with the CRO continuing to rely on Sesen for future multilingual clinical trial support and linguistic validation needs.

This outcome reflects Sesen’s commitment to delivering compliant, patient-centered translations that meet both regulatory expectations and the practical demands of global clinical research.

Why Sesen

Sesen is a trusted partner for COA and PRO translation in global clinical trials, with deep expertise in managing complex, multi-language validation projects for oncology and other therapeutic areas. Our team specializes exclusively in life sciences translation and localization, bringing domain-specific knowledge that ensures precision, compliance, and cultural sensitivity at every step.

We operate in full alignment with industry and regulatory standards, including ISPOR Principles of Good Practice, ISO 17100, and ICH Good Clinical Practice (GCP). This commitment to quality and compliance ensures that all deliverables meet the expectations of global health authorities such as the FDA, EMA, and PMDA.

Sesen’s workflows are powered by an in-house quality assurance team and a proprietary project management system designed specifically for regulated life sciences content. This infrastructure enables real-time collaboration, version control, and audit-ready documentation across all stages of the linguistic validation process.

With a proven track record supporting top CROs and pharmaceutical sponsors worldwide, Sesen consistently delivers scalable, submission-ready translations that support faster approvals and better patient outcomes in multinational clinical trials.

What the Client Said

The clinical project lead at the CRO shared the following feedback after the successful completion of the linguistic validation project:

“Sesen demonstrated expert knowledge, flawless execution, and unmatched attention to detail. Their work helped us meet global regulatory expectations on time and with full confidence. Coordinating 25 validated language versions across multiple regions is never easy, but Sesen made the process seamless and reliable. They are one of the few partners we trust for high-stakes clinical trial translations.”

This testimonial reflects Sesen’s commitment to quality, transparency, and partnership in delivering validated, regulator-ready COA translations that meet the demands of multinational oncology trials.

Related Services

Sesen supports global clinical trials with a full suite of specialized language services tailored to the regulatory and scientific demands of life sciences.

These services work together to ensure regulatory compliance, improve data quality, and accelerate global trial readiness for sponsors and CROs alike.

Need Expert Linguistic Validation for Your Next Global Trial?

Partner with Sesen for compliant, accurate, and patient-focused COA and PRO translations in 150+ languages. Our validated workflows and life sciences-only focus help accelerate global submissions and ensure data integrity.

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