White Paper

Decentralizing Clinical Trials

Decentralizing Clinical Trials

Pages 13 Pages

The ACRO white paper outlines how decentralized clinical trials (DCTs) improve access, patient centricity, and resilience by using telemedicine, home visits, wearables, and eConsent. COVID-19 accelerated adoption, with case studies showing trials rescued or converted remotely within days. DCTs reduce burdens of travel, expand diversity, and enable real-time data capture, but challenges remain for early-phase or safety-critical studies. ACRO’s Quality-by-Design Manual and Risk Assessment tools guide sponsors in identifying risks, documenting processes, and ensuring compliance. Success requires early regulator engagement, robust IT systems, clear data flows, and strong patient involvement, making DCTs a sustainable model for future research.

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