Corporate Translations

Translation Moves Clinical Outcomes Forward

LINGUISTIC VALIDATION

A preferred and trusted authority on the linguistic validation and management of Clinical Outcomes Assessments.

  • Licensing Management Experts
  • Over 15,000 COA Translations
  • All Therapeutic Areas

LINGUISTIC VALIDATION EXPERTS

We are a leading and trusted authority on the linguistic validation of Clinical Outcomes Assessments (COA). Whether intended for a patient (PRO), clinician (ClinRO), or observer (ObsRO), our translations are accurate as well as culturally and conceptually equivalent to the source instrument. Our experience in translating COAs has expanded across a variety of therapeutic areas, including cardiovascular, allergy/respiratory, oncology, gastroenterology, inflammation, neurology, infectious diseases and vaccines.

Furthermore, our steadfast global relationships with our translators, interviewers, instrument developers, survey research experts, clinicians and in-country reviewers allow us to expedite each linguistic validation project with ease and scientific accuracy. If you need assistance developing COA strategies in order to satisfy regulatory or reimbursement needs, we can help.

Clinical Outcomes assessments

Our singular focus in translating documentation for the life science industry has made us experts in translating clinical outcomes assessments for use in both paper and electronic format.

  • PRO Questionnaires
  • ClinRO Questionnaires
  • ObsRO Questionnaires
  • eCOAs
  • Abstracts & Manuscripts
  • Patient Diaries
OUR METHODOLOGIES

Our Methodologies

Our state-of-the-art linguistic validation process and COA added-value services ensure both accuracy and timely completion of your documents.

Our linguistic validation process is modeled on the U.S. Food and Drug Administration PRO guidance document as well as on the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.

The linguistic validation process includes the following key steps:

  • Concept elaboration
  • Dual forward translation
  • Harmonization
  • Back-translation
  • Survey Research Expert review
  • Developer review
  • Clinician review
  • Client subsidiary review
  • Recruitment of patients
  • Cognitive debriefing of patients
  • Validation reports and certifications

COA ADDED-VALUE SERVICES

We manage the entire life cycle of your COA translations. Our approach provides an array of support services designed to save you time and increase your ROI:

  • Copyrights and licensing management
  • Developer coordination
  • Detailed and accurate instrument research
  • COA repository management
  • Manuscript and poster creation
eCOA

electronic Clinical Outcomes Assessments

With more and more sponsors utilizing electronic devices to conduct their clinical trials, it is extremely important that the eCOAs are developed and linguistically validated with the same level of precision as a traditional paper COAs. Partnering with Corporate Translations ensures a thorough review and proper linguistic validation of the adapted instrument for use on an eCOA or ePRO device when required.

Developing instrument translations for use on eCOA devices requires early collaboration among the sponsor, eCOA vendor and language service provider. This important step can eliminate many technical problems and instrument administration issues later in the process. Our experience and expertise in this area have led us to develop a series of best practices for eCOAs including:

  • Upfront communication between sponsor, eCOA vendor and translation provider
  • Close coordination throughout project between all three parties via regular teleconferences
  • Simultaneous creation of paper-administered translations as back-up
  • Bank of validated eCOAs for future use by the client
  • Documentation that eCOAs match validated translations
  • Font pre-test
  • eCOA device training where applicable

Developer Relations

We understand the complex nature of creating COAs for inclusion in multinational clinical trials. Our meaningful relationships with instrument developers have led to the creation of COA instrument websites. These websites are designed to facilitate the availability and use of these instruments. Each site contains a description of the instrument, instructions for obtaining permissions to use the instrument, an updated list of available translations, developer biographies, related research and more.

Among our COA Instrument Websites are:

If you are an instrument developer interested in learning more about how we may assist in creating a website to promote the use of your instrument, or if you are a sponsor seeking more information on the linguistic validation of COA instruments you may be researching for an upcoming trial, please email coasearch@corptransinc.com.

  • 99% On-Time Delivery
  • Exceptional Customer Satisfaction
  • Less Than 2% Error Rate

QUALITY AND PERFORMANCE

Our ISO 9001:2008, ISO 13485:2003 and iso 17100:2015 Quality Management System acts as the foundation for delivering translations of unparalleled quality. Through the intelligent use of our linguistic resources, translation memory and document archives, we quickly identify related documents and ensure that they are translated quickly, accurately, and cost-effectively.

Our state-of-the-art Linguistic Validation process is modeled on the U.S. Food and Drug Administration PRO guidance document as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations. Our rigorous approach ensures that all clinical outcomes assessments translated for your trial are accurate and culturally equivalent to the source.

Learn more about our quality and performance
LANGUAGE LIST

Language List

Corporate Translations provides translation, linguistic validation and mulitmedia production services in more than 100 languages, including all European, Asian, African, Middle Eastern and American languages.

View our full translation language list
Let Us Help You

A quick response is vital to maintaining the momentum of your projects. That’s why all of our translation quotes are delivered in less than 24 hours. Whenever you have a translation challenge, you can count on Corporate Translations' client service specialists to provide you with a prompt, thorough response tailored to your needs.

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