OPP003 📄 Overview A regulatory-compliant SaMD platform designed to facilitate decentralized clinical trials (DCTs) by securely capturing high-fidelity real-world data from wearables, patient-reported outcomes (ePRO), and remote diagnostics, while providing engaging patient support and telemedicine capabilities to enhance participation and data quality. Key technologies: 👤 Target users: 👍 Benefits Faster and more diverse patient recruitment • Reduced site burden and operational costs for trials • Generation of rich real-world evidence (RWE) • Improved patient convenience and retention in trials • Enhanced data quality and capture frequency • Accelerated drug and device development Use bullets or new lines. 👎 Challenges Ensuring data interoperability across diverse devices and systems • Regulatory acceptance of RWE as primary or co-primary endpoints • Maintaining robust cybersecurity and data privacy (HIPAA, GDPR, GxP) • Addressing patient digital literacy and access disparities • Logistics of distributing and managing connected devices for participants • Ensuring data integrity and traceability for regulatory audits 📋 Regulatory & Validation GxP compliance (GCP, GLP, GMP) for all trial-related processes • FDA Part 11 compliance for electronic records and signatures • SaMD classification for any diagnostic, monitoring, or therapeutic claims of incorporated components • Need for comprehensive risk management and validation of data capture methods