Safety Reporting in Early Phase Trials

Early phase clinical trials play a critical role in evaluating the safety and tolerability of new drugs. Accurate and timely safety reporting during this phase is essential for identifying initial adverse effects and shaping the development pathway. As investigational drugs are tested in humans for the first time, researchers must employ robust safety monitoring systems that comply with regulatory standards. These include adverse event (AE) and serious adverse event (SAE) reporting protocols, real-time monitoring dashboards, and cross-functional collaboration among investigators, safety officers, and sponsors. Technology-driven solutions like electronic data capture (EDC) and centralized monitoring systems streamline the reporting process, enabling quicker detection of safety signals. Harmonization of safety reporting requirements across regions is also pivotal for global development programs. This session examines current methodologies, global requirements, and emerging best practices for ensuring participant safety and data integrity in early phase trials, ultimately supporting the safe progression of promising therapies.

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