Patient-Reported Outcomes & Feedback Loops: Designing ePRO Systems that Regulators Trust
Patient-Reported Outcomes & Feedback Loops: Designing ePRO Systems that Regulators Trust Build Regulator-Ready PRO Programs with Real Feedback Loops Strategy and governance: make patient-reported data central, not decorative When patient-reported outcomes matter to a study’s benefit–risk story, they must be treated as primary data streams—not “nice-to-have” add-ons. A strong program begins by defining what exactly…