Novel Endpoint Development & Digital Biomarkers: Strategy, Validation, and Global Qualification Pathways
Novel Endpoint Development & Digital Biomarkers: Strategy, Validation, and Global Qualification Pathways Designing Trustworthy Novel Endpoints and Digital Biomarkers: Strategy to Qualification Across Regions Anchor the endpoint strategy: what matters to patients, what regulators accept, and how to make it measurable Novel endpoints succeed when they are meaningful, measurable, and manageable. “Meaningful” means anchored to…