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What Are COAs and eCOAs?

Clinical Outcome Assessments (COAs) are tools used in clinical trials to capture how patients feel, function, or survive. These assessments provide critical evidence of treatment benefit from the perspective of patients, caregivers, or clinicians. COAs fall into four primary categories:

  • Patient-Reported Outcomes (PROs): Direct reports from patients about their health condition, symptoms, or quality of life.
  • Observer-Reported Outcomes (ObsROs): Reports from caregivers or observers about a patient’s condition when self-reporting is not feasible.
  • Clinician-Reported Outcomes (ClinROs): Assessments made by trained clinical professionals based on observation or clinical judgment.
  • Performance Outcomes (PerfOs): Evaluations based on standardized tasks performed by the patient, often measuring cognitive or physical abilities.

As global trials adopt decentralized and digital models, traditional paper-based COAs are increasingly transitioning to electronic formats. Electronic Clinical Outcome Assessments (eCOAs) leverage digital platforms such as tablets, smartphones, and web interfaces to streamline data collection, reduce variability, and improve compliance tracking. Regulatory bodies including the FDA and EMA recognize the value of eCOAs in enhancing data quality and patient engagement.

Linguistic and cultural accuracy is critical to the validity of COA and eCOA instruments across international sites. Improper translation or lack of cultural adaptation can compromise data integrity and affect the comparability of results. High-quality COA translation requires rigorous linguistic validation, cognitive debriefing, and close collaboration with instrument developers and regulatory teams.

Sesen supports sponsors and CROs in delivering COA and eCOA instruments that meet regulatory standards and reflect the lived experiences of diverse patient populations worldwide.

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Sesen’s End-to-End Support for COAs and eCOAs

Sesen provides full-lifecycle language support for Clinical Outcome Assessments (COAs) and electronic COAs (eCOAs), tailored to meet the requirements of global clinical trials. Our workflows are built around ISO 17100-certified processes and follow best practices from ISPOR and regulatory guidance to ensure linguistic accuracy, conceptual equivalence, and submission readiness.

We assist clients in securing translation rights and permissions from instrument owners and licensing bodies such as Mapi, FACIT, and PROQOLID. Our team manages communication, documentation, and approval tracking to keep projects compliant and on schedule.

When adapting COAs for digital deployment, we work with eCOA vendors and study teams to guide format conversion. We support layout optimization, character limitations, platform compatibility, and localization of UI strings for use on mobile devices and tablets.

Our multi-step translation workflow includes dual independent forward translations, a reconciled version, and a back translation for review. This process ensures conceptual fidelity and captures nuances critical to accurate data collection.

We conduct linguistic validation in accordance with regulatory and ISPOR standards. This includes cognitive debriefing interviews with representative patients or caregivers in each target market to confirm clarity, cultural relevance, and comprehension.

Native-speaking clinicians or regulatory affiliates conduct in-country reviews to provide local feedback on terminology and clinical appropriateness. Our team manages the reconciliation of reviewer input to deliver finalized, market-ready translations.

For studies using electronic platforms, we perform linguistic quality checks within the eCOA interface. This includes verifying text display, screen transitions, and content integrity across device types to ensure a seamless user experience.

Sesen delivers fully vetted translations and validation documentation aligned with the expectations of ethics committees, IRBs, and global regulatory authorities. All files are formatted and packaged to support smooth submission and audit readiness.

With deep expertise in clinical research and multilingual project execution, Sesen helps life sciences teams deliver COA and eCOA instruments that are both scientifically sound and globally deployable.

Expertise in COA Licensing and Validation

Sesen brings specialized experience in navigating the licensing and validation requirements for Clinical Outcome Assessments (COAs) across therapeutic areas. Our team supports sponsors and CROs in managing the complexities of COA use in global clinical trials, ensuring regulatory compliance and data reliability.

We work closely with leading instrument licensing bodies such as Mapi, PROQOLID, FACIT, and other proprietary instrument owners. Our services include facilitating license applications, managing correspondence with rights holders, and tracking usage terms across study phases. This ensures that clients meet all contractual and regulatory obligations for COA use and translation.

Sesen also provides end-to-end coordination of linguistic validation activities, including forward and back translation, reconciliation, and reviewer input. As part of this process, we organize cognitive debriefing sessions with representative patients or caregivers to evaluate the clarity, cultural appropriateness, and conceptual equivalence of translated instruments.

Our approach aligns with ISPOR guidelines and supports the generation of documentation required by regulatory agencies and institutional review boards. By combining deep knowledge of COA licensing with operational precision, Sesen helps clinical teams implement validated and compliant outcome measures for global research.

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Digital Migration and eCOA-Specific Expertise

Sesen provides specialized support for the digital migration of Clinical Outcome Assessments (COAs) to electronic formats used in clinical trials. Our team collaborates with leading eCOA vendors such as Medidata, YPrime, Signant Health, and others to ensure accurate, efficient, and compliant deployment of multilingual eCOA instruments.

We help clients adapt linguistically validated COA content for use on digital platforms, taking into account formatting constraints, character limits, and interface-specific variables. Our linguists and localization engineers work together to preserve content integrity while optimizing for usability across device types, including smartphones, tablets, and web-based systems.

Sesen also supports the localization of user interface (UI) and user experience (UX) elements within eCOA applications. This includes translating instructional text, alerts, navigation menus, and other embedded content to ensure patient comprehension and platform consistency in every language.

Our services are tailored to meet the operational and regulatory expectations for eCOA deployment in global trials. We follow ISO 17100 standards and vendor-specific validation protocols to help sponsors maintain the quality and comparability of patient-reported data across markets.

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Supporting COAs in Decentralized Clinical Trials

As decentralized clinical trials (DCTs) become increasingly adopted across therapeutic areas, COAs and eCOAs play a critical role in enabling remote data collection and patient engagement. Sesen supports sponsors and CROs in adapting COA instruments for hybrid and fully decentralized models to ensure linguistic accuracy, digital usability, and regulatory compliance.

We provide language services tailored for COA delivery through Bring Your Own Device (BYOD) models, provisioned tablets, and web-based platforms. Our linguists adapt validated instruments for device-specific constraints while preserving conceptual equivalence and user comprehension.

Sesen also translates and localizes associated patient-facing materials, including caregiver guides, instructional content, and multimedia elements that support patient onboarding and retention. This ensures consistency and clarity across languages in both digital and paper-based formats.

Our services extend to the localization of eConsent forms, electronic diaries, and other electronic patient-reported outcomes (ePROs) that often accompany eCOA deployments in DCTs. We ensure these components meet both regulatory standards and user experience requirements across diverse populations.

By aligning COA and eCOA content with the operational realities of decentralized trials, Sesen helps clinical teams deliver reliable outcomes data while enhancing global patient accessibility.

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Technology Partnerships and Platform Familiarity

Sesen works seamlessly with leading eCOA technology providers to ensure that translated instruments are accurately implemented and fully functional within electronic data capture platforms. Our experience across major eCOA systems enables sponsors and CROs to streamline global deployment and avoid costly delays during validation and user acceptance testing.

We are familiar with platform requirements and workflows for vendors such as Medidata Rave, YPrime, Signant Health, TrialKit, Clario, and ERT. Our team understands the nuances of integrating translated content into each system’s interface and has supported successful eCOA rollouts across a variety of study phases and therapeutic areas.

Sesen provides expert localization of user interface text, instructional content, and platform navigation elements. We adapt language for screen size constraints, character limits, and platform-specific design guidelines, helping to optimize user experience across mobile, tablet, and web-based devices.

By aligning linguistic and technical considerations, Sesen ensures that translated COA and eCOA content performs as intended within the digital environment, supporting both regulatory compliance and patient usability across study regions.

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Linguistic Quality and Regulatory Comliance

Sesen applies a rigorous quality framework to all COA and eCOA translation projects to ensure linguistic accuracy, regulatory compliance, and cultural relevance across global markets. Our workflows follow established best practices in clinical research translation and are fully aligned with international quality standards.

We use a Translation, Editing, and Proofreading (TEP) process in which each stage is completed by separate professional native linguists. This independent review model allows for objective validation of terminology, clarity, and conceptual consistency. The TEP workflow is essential for producing reliable and reproducible translations suitable for regulatory submissions.

Sesen accounts for country-specific and language-specific regulatory requirements when delivering COA and eCOA translations. We are familiar with the expectations of ethics committees, institutional review boards, and health authorities across North America, Europe, Asia Pacific, and Latin America. Our team proactively incorporates local review feedback and applies regionally preferred terminology where appropriate.

All quality assurance procedures at Sesen are governed by ISO 17100 for translation services, ISO 9001 for quality management systems, and ISO 13485 for medical device and clinical documentation workflows. This certification structure provides a standardized foundation for linguistic and operational excellence across therapeutic areas and study phases.

By combining deep subject matter expertise with structured quality controls, Sesen ensures that COA and eCOA translations meet the highest standards of linguistic precision and regulatory readiness.

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Supported Languages and Therapeutic Areas

Sesen supports COA and eCOA translation projects across a broad range of therapeutic areas and global study regions. Our services are backed by a network of professional native linguists with subject matter expertise in clinical research and regulatory documentation.

We offer validated translation and linguistic validation services in more than 150 languages, ensuring accurate and culturally appropriate content delivery across diverse patient populations. All linguists are trained in the terminology and tone specific to COA instruments and undergo a structured onboarding and quality review process.

Sesen has extensive experience managing COA translation workflows in high-impact therapeutic areas, including:

  • Central Nervous System (CNS): Neurology, psychiatry, neurodegenerative diseases
  • Oncology: Solid tumors, hematologic cancers, immunotherapy trials
  • Rare Diseases: Orphan indications with limited patient populations and high regulatory scrutiny
  • Pediatrics: Age-appropriate language adaptation and ObsRO instruments

Our global capabilities allow us to deliver consistent linguistic quality across sites and regions while meeting the scientific and regulatory demands of each therapeutic area. Whether your study requires PRO, ObsRO, ClinRO, or PerfO instruments, Sesen provides the language support needed to achieve high-quality, submission-ready data.

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Why Sesen

Sesen is a specialized language solutions provider focused exclusively on life sciences. Our deep expertise in clinical research, regulatory standards, and global language compliance allows us to deliver high-impact COA and eCOA translation services that support the success of multinational clinical trials.

Our team includes dedicated project managers with direct experience managing COA and eCOA workflows, including licensing coordination, linguistic validation, cognitive debriefing, and digital migration. They serve as a single point of contact, ensuring consistent communication, proactive risk management, and full lifecycle visibility across all study languages.

Sesen has a proven track record supporting global clinical trials for pharmaceutical, biotech, and medical device companies. We have successfully delivered COA translation and validation projects across all major markets, including North America, Europe, Asia Pacific, and Latin America. Our work has supported submissions to the FDA, EMA, PMDA, and other regulatory authorities.

With ISO-certified processes, subject matter expertise, and a client-centric approach, Sesen is uniquely positioned to help clinical teams implement COA and eCOA instruments that are both linguistically sound and globally compliant.

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How Sponsors Use Sesen for COA Projects

Sesen partners with sponsors and CROs to solve real-world challenges in the deployment of COA and eCOA instruments. Below are examples of how we support high-stakes clinical programs with compliant, scalable language solutions.

A biotechnology sponsor selected Sesen to translate and validate a licensed PRO instrument for a rare disease Phase III trial. The project included dual forward and back translation, cognitive debriefing, and in-country review across 12 languages. We coordinated licensing with the instrument developer and delivered regulatory-ready packages for FDA and EMA submission.

For a global oncology study, Sesen supported the transition of a validated COA from paper to electronic format using the YPrime eCOA platform. Our team adapted translations to match interface constraints, localized UI elements, and conducted linguistic QA within the digital environment. The final deployment maintained full content fidelity and passed sponsor and vendor validation reviews.

In a pediatric clinical trial, Sesen provided ObsRO translations in six languages, followed by cognitive debriefing with parent caregivers. Our linguists adapted age-appropriate language, and our team managed IRB-compliant validation interviews. Final deliverables met linguistic clarity, cultural suitability, and submission standards across all participating countries.

These use cases reflect Sesen’s operational depth, therapeutic expertise, and commitment to delivering high-quality COA solutions that support global clinical success.

Client Success Stories

Sesen supports global clinical trial teams with high-quality COA and eCOA translation solutions that meet the demands of regulatory agencies and diverse patient populations. Our proven track record includes successful collaborations with leading pharmaceutical, biotechnology, and medical device companies across complex therapeutic areas and study phases.

Clients rely on Sesen for:

  • Accelerated turnaround of multilingual COA validation packages for global trial launches
  • Seamless coordination of cognitive debriefing and in-country review processes across multiple markets
  • Expert adaptation of licensed PRO instruments for electronic administration using top eCOA platforms

Our work has contributed to successful submissions to the FDA, EMA, and other regulatory bodies, helping sponsors maintain compliance while improving patient engagement and data quality.

Sesen’s commitment to quality, responsiveness, and operational transparency has earned the trust of sponsors, CROs, and clinical research teams worldwide.

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Additional Resources

To support your COA and eCOA planning, Sesen offers curated tools and reference materials designed to improve project readiness, streamline execution, and strengthen regulatory alignment across global studies.

Checklist for COA/eCOA Translation Readiness

A practical guide to help sponsors and CROs assess their preparedness for multilingual COA deployment. Includes key considerations for licensing, platform selection, linguistic validation, and regulatory documentation.

Download PDF

Standardized terminology and formatting guidance ensure consistency across translations and clinical documentation.

These resources help clinical teams align linguistic operations with study timelines, compliance goals, and global patient engagement strategies.

Ready to Launch Your COA or eCOA Translation Project?

Connect with our life sciences language experts to discuss your specific instrument, target markets, and regulatory requirements. We will help you deliver linguistically validated and submission-ready content that supports global trial success.

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