Xtalks — The Life Science Community™, Online webinar
2026-09-08
The concept of Real-Time Clinical Trials (RTCT) has recently gained significant attention following the FDA's introduction of the RTCT initiative and the launch of pilot programs to explore its feasibility. Traditionally, clinical trials have relied on periodic data collection, cleaning, analysis and reporting, resulting in potential delays between data generation and clinical decision-making. This webinar explores how RTCT could address these delays through a more continuous and connected approach to study oversight. RTCT envisions an environment in which safety, operational performance and the benefit-risk profile can be monitored, evaluated and acted upon as data are generated throughout a study. The initiative addresses several longstanding challenges in clinical research, including operational inefficiencies, delays in data availability and limited real-time visibility into study conduct, patient safety and treatment effectiveness. This webinar will discuss the regulatory vision driving its development and its potential impact on sponsors, CROs, investigators, data monitoring committees (DMCs), newly required independent safety assessment entities (ISAEs) and regulatory agencies. Participants will gain insights into how advances in digital technologies, artificial intelligence (AI), electronic health records (EHRs) and real-time analytics, guided by aggregate safety and benefit-risk assessment planning, may result in a new generation of continuous clinical trial oversight and decision-making. Attendees will also learn about current challenges involving source-to-EDC data flow, interoperability, data quality, privacy protection, governance and regulatory compliance. The webinar will examine opportunities to improve patient safety, trial quality, operational efficiency and development timelines, as well as practical considerations involving technological readiness, organizational transformation, assessment planning and regulatory expectations. Register for this webinar to learn how RTCT may improve patient safety, trial oversight and clinical decision-making.
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Invited Speakers:
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(Moderator) Tai Xie, PhD, CEO, CIMS Global (Panelist) Randall Hein, Founder & Managing Partner, Heinsight (Panelist) Jay Herson, PhD, Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health (Panelist) Scott Proestel, MD, Principal, Bethesda Pharmaceutical Consulting, LLC (Panelist) Greg Ball, PhD, Safety Data Scientist, ASAPprocess Consulting
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