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. 

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

24/7

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.

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News and Thought Leadership

The C3 Summit: Boston Recap

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world experience. In this recap of the Boston session, we will review key points from each session.  Session 1: COA/eCOA Innovations – Licensing Hiccups, Linguistic Validation, ePRO Migration, and Best ...

The C3 Summit: Boston Recap

How Medical Writing Can Drive Patient Engagement

Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and...

A Conversation with Dr. Elin Haf Davies of Aparito

The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder & ...

Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities

As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU ...

How to Maximise Value and Avoid Failure During Life Sciences Dealmaking

Please complete the form below to access the on-demand recording of our webinar. A fantastic expert panel of life sciences dealmaking veterans from AstraZeneca and Merck, with 100 years' collective experience, share their insights on key dealmaking strategies, best practices ...

Centralizing Global Content Solutions for Medical Affairs

With a rapidly evolving landscape and the introduction of new technologies and emerging therapeutics, medical affairs professionals are tasked with remaining in lockstep with the latest industry developments. From a content perspective, this means not only maintaining clear...

Automation for MDR & IVDR: A Three-Part Seminar - Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements

Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements ...

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