Real-world evidence
Continuous biomarkers from CGM, wearables, and patient-reported outcomes. Track drug and device effectiveness in real-world settings. Supplement RCTs with longitudinal observational data. Generate evidence for Asia Pacific regulatory submissions and health technology assessments.
Beyond traditional RCTs
Randomized trials provide efficacy data in controlled settings. But Asia Pacific regulators increasingly want real-world effectiveness. How does the drug or device perform when patients skip doses, face comorbidities, or live in diverse real-world environments?
Continuous digital biomarkers
CGM captures glucose every 5 minutes. Wearables track steps, sleep, heart rate continuously. Supplement quarterly HbA1c with daily time-in-range. Capture real-world adherence, not just trial protocol compliance.
Evidence for Asia Pacific regulators
HSA Singapore, PMDA Japan, TGA Australia, and NMPA China increasingly accept RWE for post-market surveillance and regulatory decision-making. Export analysis-ready datasets with full audit trails. Meet stringent adverse event reporting timelines and registry requirements.
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