Over the past couple of decades, the FDA and other regulatory bodies have pushed for greater patient diversity and an overall patient-centric approach in clinical trial management. The 21st Century Cures Act formalized this patient-centric approach, emphasizing patient-focused drug development and a push to collect real world data on the patient experience.
Linguistic validation is a critical tool in the effort to ensure patient diversity and develop a robust understanding of the patient experience across global populations. By adapting patient reported outcome instruments to a variety of linguistic and cultural demographics, drug development companies gain a broader and more in-depth understanding of the patient experience at the clinical trial stage.
Register for this webinar to learn about using linguistic validation as a tool to meet the patient diversity requirements of clinical trials.
Speakers
Joshua Maislin, Sr. Customer Success Manager, CSOFT
Joshua has worked to help pharmaceutical companies in their global efforts for over 15 years. He has focused specifically on helping companies translate and adapt patient facing clinical trial material for a global patient population. He has a degree in Linguistics.
Message Presenter
Gerrit Blauvelt, Sr. Director, North America Operations, CSOFT
Gerrit has architected, implemented and streamlined localization programs for tier-1 enterprise multinational businesses in technology and life sciences for more than a decade. He specializes in the application of analytics and automation technologies to produce high quality and predictable service outcomes.
Message Presenter
Dr. George L. King, Professor of Medicine and Ophthalmology at Harvard Medical School, and Director of Research, Senior Vice President, Joslin Diabetes Center
George L. King, MD is the Director of Research, Senior Vice President, and Head of the Section on Vascular Cell Biology at Joslin Diabetes Center. Dr. King founded the Asian American Diabetes Initiative, as well as the Medalist Study, created to discover protective factors to prevent the development of diabetic eyes, kidneys, and nerves. His numerous awards include the Champalimaud Award and the Cogan Award from the Association for Research and Vision and Ophthamology.
Message PresenterWho Should Attend?
- Clinical Trial Protocol Design
- Clinical Operations
- R&D
- Regulatory Affairs
- Patient Recruitment & Retention
- Patient Engagement
- Medical & Scientific Affairs
- Market Access
- Healthcare Diversity
What You Will Learn
In this webinar, participants will learn about:
- How linguistic validation addresses the myriad challenges involved in collecting diverse and robust patient data across global populations
- How implementing this process will lead to more valid, actionable data on the global patient experience
- The details of the linguistic validation process, and how it helps ensure both patient diversity and robust patient experience data collection
Xtalks Partner
CSOFT Health Sciences
CSOFT Health Sciences provides end-to-end medical translation services for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
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