Clinical Outcome Assessment (COA) Solutions

Access end-to-end consultation, from licensing to electronic clinical outcome assessment (eCOA) migration, and improve the patient and healthcare provider experience with all types of COAs.  

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Electronic Clinical Outcome Assessment

Minimize Time-to-Market, Mitigate Risk, and Ensure Regulatory Compliance in Global Studies

Enable superior patient data quality with centralized COA management. Regulatory authorities and patient advocates are demanding more visibility than ever before into patient engagement and safety measures. Sponsors are tasked with improving their data collection strategies while navigating the ever-changing landscape of compliance.

TransPerfect helps sponsors and eCOA providers streamline this complexity with AI-powered eCOA migration and data collection. These COA solutions improve ease, speed, compliance, and quality of patient data reporting - all while minimizing the risk for error. Meet the next generation of clinical data integrity and patient safety.

Translation and COA Linguistic Validation

License, translate, and adapt COAs across a variety of therapeutic areas, while improving data quality. Translate and validate patient-reported outcomes (PRO), clinician-reported outcomes (ClinRO), observer-reported outcomes (ObsRO), and performance outcomes (PerfO). Our specialists follow the latest guidelines and ISPOR Good Practice recommendations.

Our comprehensive COA solutions include:

  • Translation and Linguistic Validation COAs
  • Licensing/Copyright Services
  • Face Validity Assessment
  • Translatability Evaluation
  • eCOA Integration and Usability Testing
  • Cognitive Debriefing for Source Questionnaires
  • Web-Based COA Library and Online Document Management
  • IVRS Prompt Recording
  • Interview Transcription
  • Study Binder Formatting
  • Research Abstracts/Posters/Manuscripts

GlobalLink XCompare™ for eCOA Migration

Streamline your eCOA process with an industry-leading migration solution that improves the ease, speed, compliance, and quality of patient data reporting. GlobalLink XCompare is our proprietary risk-mitigating technology used during the migration of validated paper COAs to electronic platforms.

  • Our end-to-end eCOA solutions include:
  • Paper to eCOA content adaptation
  • eCOA usability testing
  • Licensing
  • Translation/linguistic validation
  • Migration assessment
  • eCOA adaptation & migration  
  • Screenshot review & certification  
  • Post-localization device testing  
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Applanga™ for Screenshot Review

Remove the need for passing technical files back and forth and rounds of review. Applanga™ connects directly to the ePRO/eCOA app via API. TransPerfect specialists manage the full testing process and remove the ePRO vendor, which allows for 2.5 times faster turnaround time and reduced project management.  

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Licensing and Copyright Support

Ensure a smooth permissions process with TransPerfect’s COA Division licensing and copyright team. TransPerfect’s long-standing relationships with copyright holders, authors, and developers streamlines necessary processes and procedures.  

COA Library and Document Management

Store all clinical outcome assessments (PRO, ClinRO, ObsRO, and PerfO) as well as documentation from the development of the assessments, COA qualification submissions, licensing/copyright information, final (linguistic validation) reports, certifications, all relevant eCOA documentation and screenshots, final PRO batteries, and any additional documentation in the cloud. Track and manage all ongoing activities surrounding formatting projects, eCOA projects, translation projects, and the management of COA content.

Rater Training Support

Provide a comprehensive suite of solutions to support rater training efforts through TransPerfect Linguistic Validation. We offer translation and adaptation of all training materials, including those delivered by video and through interactive e-learning courses. TransPerfect has over 1,200 clinician reviewers in our network to review any Clinician-Reported Outcomes (ClinRO) work, from neuropsychologists to urologists and almost anything in between. 

Patient Interviews

Specialized end-to-end support for patient-centered outcomes research, including the execution of patient interviews throughout the life cycle of the clinical study. As a trusted partner to CROs and sponsors, TransPerfect offers a comprehensive range of interview services, including concept elicitation, patient experience, and exit interviews. Each collaboration includes a thorough review of the sponsor’s goals to ensure that qualified interviewers are trained on the study-specific requirements. We also provide timely delivery of interview materials, such as transcripts, translations, adverse event reports, and feedback reports. 

Upholding the highest industry standards to ensure conceptual equivalence and cultural appropriateness for a variety of therapeutic areas.

Protect patient safety

All TransPerfect COA Division production staff complete ongoing Good Clinical Practice (GCP) training, which contributes to the high quality of our deliverables. Our clients also have access to ongoing training on the most up-to-date industry standards for the translation of clinical outcome assessments as well as full-service consulting resources.

Accurately capture patient data

TransPerfect’s linguistic validation team has extensive knowledge of industry standards as stated in FDA, EMA, and ISPOR Guidance documents. As an ISO- and EN-certified company, TransPerfect’s linguistic experts and offerings comply with ISO and EN international standards and undergo regular audits for quality assurance.

Meet global compliance standards

TransPerfect’s 21 CFR Part 11 compliant Trial Interactive online document repository allows for web-based archiving of COAs for easy access and retrieval. It stores all clinical outcome assessments (PRO, ClinRO, ObsRO, PerfO), as well as all relevant eCOA documentation.

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A Checklist for eCOA Solution Deployment

Innovation in COA by the Numbers

97 %

Risk mitigation during eCOA migration

50 %

Faster review cycles

2.5 x

Faster turnaround times by eliminating ePRO vendor

100 %

Compliance with copyright holders for legal requirements


365 days of the year access

Therapeutic Areas

  • Aesthetic Medicine
  • Cardiology
  • CNS/Neurology/Psychiatry
  • Congenital/Hereditary Diseases
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genetic Disease
  • Healthy Volunteers
  • Hemic/Lymphatic
  • Hepatology
  • Immunology
  • Infectious Diseases
  • Musculoskeletal
  • Nephrology
  • Neurology
  • Obstetrics/Gynecology
  • Oncology
  • Ophthalmology
  • Otolaryngology
  • Otorhinolaryngology
  • Orthopedics
  • Pediatrics
  • Pain
  • Plastic Surgery
  • Psychiatry/Psychology
  • Respiratory
  • Rheumatology
  • Sexual Functioning
  • Sleep Disorders
  • Spondylitis
  • Trauma
  • Urology
  • Vaccines

Certifications and Memberships

TransPerfect is an active participant in the outcomes research and health economics world and has a strong record of academic achievement and participation.

C-Path Institute

News and Thought Leadership

The Ultimate Clinical Trial Translations Checklist

Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a study operates across cultures, countries, and continents, these pain points of cost, risk, and time are compounded by the addition of translation and localization requirements. Study teams ...

The Ultimate Clinical Trial Translations Checklist

CCMS: A Good Fit for Pharmaceutical and Clinical Research Organizations?

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Omnichannel Marketing for the Pharmaceutical Industry

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LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site ...

Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials

Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers,...

Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content

In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and...

Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management

Introduction: In the field of clinical research, a robust data management process is essential for driving success. Efficiently handling vast amounts of data, ensuring accuracy and consistency, and extracting meaningful insights are vital, particularly in the case of global...

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