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
Keywords:

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.

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.

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.

Who Should Attend?

Sponsors & CROs considering using ePRO/eCOA or other clinical outcomes assessments in global trials.

Job roles which will benefit include: HEOR, Clinical Operations, eClinical Technologies, Regulatory Affairs, Data Management, Outsourcing and Procurement.

Xtalks Partners

CRF Health

CRF Health is a leading provider of electronic Clinical Outcome Assessments (eCOA) solutions for global clinical trials. With experience on over 545 trials across more than 70 countries and in over 100 languages, CRF Health’s TrialMax eCOA solutions consistently demonstrate the industry’s highest data accuracy, patient and site compliance and patient retention. CRF Health’s TrialMax eCOA solutions improve patient engagement by fitting within the lives of patients and seamlessly integrate into clinical sites to maximize protocol compliance. Their eCOA solutions include PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes).

Transperfect

Founded over 20 years ago, TransPerfect Life Sciences is the world’s premier provider of global communication solutions to the Pharmaceutical, biotechnology, and healthcare industries. We are a women-owned business, supported by more than 85 offices on six continents, including more than 20 production hubs, TransPerfect helps life sciences companies conduct clinical developments and commercialize products on a global scale. Within this team is TransPerfect’s Linguistic Validation Practice Group, which is comprised of experts versed in maximizing the conceptual equivalence and cultural appropriateness of your multi-country COA measures in a wide range of therapeutic areas and via a variety of administration modes. Together with the entire Life Sciences team, TransPerfect’s Linguistic Validation Practice Group combines industry expertise with technology tools to provide an end-to-end clinical trial solution.

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