Translation of eCOA in Global Studies – Challenges & Solutions

Increasing competition between pharmaceutical companies to get drugs to market faster causes increased challenges:

• Companies are trying to collect more data within a clinical trial, and are therefore using more eCOA instruments than in the past
• Global studies require additional translations
• The additional work and increase competition means shortened timelines
• These additional components need to be provided to an ever increasing number of Ethics Committees, resulting in shortened timelines

This presentation discusses the translation process, needs, requirements, review cycles, and regulations surrounding the use of eCOA in clinical studies and the need for linguistic validation.

Learning objectives:

• Understand language translation considerations for implementing eCOA solutions in a clinical trial, with respect to process, timelines, and circumstances for linguistic validation
• Increase awareness of best practices when migrating a paper translation to electronic format, or when translating solely for an electronic device

Speakers

Colleen Chulis, Global Director of Linguistic Validation, TransPerfect

Colleen Chulis is the Global Director of Linguistic Validation at TransPerfect. Colleen started her career at TransPerfect in 2005 and has grown her direct team to manage over $30M annually. Colleen is an expert in the linguistic validation process of COAs, especially eCOAs, with her team managing over 300 projects a year for linguistic validation, for clients such as Merck, Pfizer, Novo Nordisk, Quintiles, and many others.

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Brielle Sydor, Account Executive of Linguistic Validation, TransPerfect

Brielle Sydor, the Account Executive of Linguistic Validation at TransPerfect, is responsible for overseeing the linguistic validation and electronic migration of clinical outcomes assessments. Her responsibilities include managing translations that comply with FDA and ISPOR guidance, conducting paper to eCOA migration assessments for multilingual studies, and creating efficiencies in the eCOA process. Brielle’s expertise in streamlining the linguistic validation and eCOA workflow has enabled her top pharma clients to file early submissions in over 100 countries. She is also responsible for overseeing TransPerfect’s relationship with CRF Health.

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Jane Carter, Program Director, CRF Health

Jane Carter is a Program Director at CRF Health overseeing two key accounts totaling 46 projects. Jane has worked in the Pharmaceutical industry for over 18 years, having started her career in IVRS at PAREXEL/Perceptive Informatics. Jane has been with CRF Health since 2005, and has extensive experience working with multiple translation providers, both for IVRS and eCOA solutions.

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