The Pharma Exec dossier contains resources to support executive decision makers within pharma to champion the appropriate use of digital clinical measures Health outcomes or physiological characteristics of an individual’s health, wellness, and/or condition that are collected digitally with a sensor. in drug development.
Resources include models of the benefits that digital clinical measures can bring to drug development programs today and in the future, the business case for including patient perspective, a summary of recent regulatory positions, and the competitive landscape for digital clinical measures.
This heat map models four categories of benefits cascading from deploying digital clinical measures across the drug development cycle: program and system-level improvements; revenue opportunities; risk reduction; and cost reduction. Download here.
This quick reference guide to processes for interacting with the US Food and Drug Administration (FDA) regarding novel endpoint development is adapted from the original developed by CTTI. Download here.
ICYMI Listen to the panel of experts from this Tour of Duty who collaborated to create the resources in this Dossier as they share their perspectives on the challenges and the opportunities to advance the use of digital clinical measures (excerpted from our launch event on April 30, 2021).