– Patient-centric approach where all procedures are done remotely (i.e., at home)
– Determined through initial protocol assessment/input and site training
– Telemedicine or in-home consult conducted by primary investigator or medical staff
– May incorporate eConsent, eDC, eISF, drug/device shipment directly to patient
– Bring Your Own Device (BYOD) app for “visits”, video/text chats, reminders
– Secure (256-bit dual encryption) cloud-based environment, HIPAA compliant, 24/7/365 support
– Centralized provisioning of required supplemental devices/systems (e.g., wearables, ePRO, eDiary) and study materials