Our presenters will follow Digital Medicine Society’s (DiMe) V3 framework and Clinical Trials Transformation Initiative’s (CTTI) framework in a hypothetical case to validate a sleep endpoint. We will identify key considerations and challenges and describe approaches for developing novel digital endpoints for use in medical product development. Additionally, we will highlight the importance of regulatory strategy in the development and validation of novel digital endpoints. At the end of the webinar, there will be an opportunity for Q&A with our speakers and additional panelists Lindsay Kehoe from CTTI and Jennifer Goldsack from DiMe.
This public webinar is ideal for attendees within:
- Digital Medicine/Health Groups
- Digital Data Groups
- Regulatory Colleagues and Vendors