OPP003_DecentralizedTrials 📄 Overview A platform utilizing digital technologies to enable clinical trials with reduced or no need for traditional site visits. It integrates patient recruitment via social/digital channels, remote consent, wearable data collection (passive and active), telehealth visits, and AI-powered data analytics for real-time monitoring of safety and efficacy endpoints. Focus on increasing diversity and access. Key technologies: 👤 Target users: 👍 Benefits Faster trial completion times • Increased patient diversity and geographic reach • Reduced patient burden and improved recruitment/retention • Real-time data insights and adaptive trial designs • Lower operational costs for trials Use bullets or new lines. 👎 Challenges Ensuring data quality and integrity from remote sources • Regulatory acceptance and guidelines for DCT models • Digital literacy and access for all participant demographics • Managing participant device provision and technical support • Cybersecurity risks for distributed data 📋 Regulatory & Validation Adherence to Good Clinical Practice (GCP) in a decentralized context. • Validation of remote data collection methods against traditional standards. • Specific guidance for eConsent and participant privacy in digital settings.