mindsON RBQM | Special Edition: Risk-Based Medical Monitoring Under ICH E6(R3) – Supporting Patient Safety with Technology

Join us for this special edition of mindsON, focused on the expanding role of Medical Monitoring in clinical trials. With the upcoming release of ICH E6(R3) guidelines, trial oversight professionals now encounter fresh requirements in risk management, patient safety, and data quality. This session will explore how these guidelines shape risk-based Medical Monitoring practices and show how AI-enhanced technology can assist medical monitors, pharmacovigilance teams, clinical operations, and data managers meet these enhanced responsibilities.

Key Topics:

• ICH E6(R3) Guidelines: Essential updates for medical monitors and clinical trial professionals concerning safety oversight, risk management, and protocol compliance.

• Practical Approaches to New Requirements: Approaches to efficiently manage and support expanded roles across various trial stages.

• Technology in Action: How a digital Subject Profiles tool simplifies workflows, enables centralized monitoring, and enhances patient safety efforts.

Who Should Attend:

Medical Monitors, Pharmacovigilance Specialists, Clinical Operations Managers, Data Managers, Quality Assurance Teams, CRO Teams, and others involved in ensuring patient safety and compliance in clinical trials.