Challenges and Opportunities in Real-Time Clinical Trials

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.

Who Should Attend
This webinar will be relevant to professionals across pharmaceutical companies, biotech organizations, CROs and clinical research teams involved in clinical trial strategy, operations, data oversight and regulatory decision-making, including:
Clinical Trial leaders and Clinical Operations professionals
Sponsors, CROs, Investigators and Study Team decision-makers
Data Monitoring Committee members and professionals involved in Safety or Efficacy Review
Clinical Data Management, Biostatistics, Statistical Programming and Analytics teams
Regulatory Affairs, Quality, Compliance and Governance professionals
Digital Transformation, AI, Automation and Clinical Technology leaders supporting modern trial infrastructure

What You Will Learn
Attendees will gain insight into:
What Real-Time Clinical Trials are and why they are gaining attention across clinical research
How real-time data access, monitoring and analytics may improve patient safety, trial efficiency and decision-making
The opportunities created by AI, automation, cloud computing and advanced analytics in modern trial oversight
Key challenges around data quality, source data integration, governance, privacy and regulatory compliance
Practical considerations for sponsors, CROs, DMCs and regulators as clinical trials become more data-driven and continuously monitored

Register free on Xtalks:
https://xtalks.com/webinars/challenges-and-opportunities-in-real-time-clinical-trials/