Risk-Based Monitoring and Trial Optimization
Risk-Based Monitoring (RBM) has become a standard approach to improve trial efficiency and data quality while focusing oversight on critical risks. This session delves into the design and implementation of RBM strategies using centralized, remote, and on-site monitoring techniques. Attendees will learn how to identify key risk indicators, develop monitoring plans, and leverage technology platforms for real-time tracking. Emphasis is placed on cross-functional collaboration between data managers, monitors, and safety teams. Case studies will illustrate how RBM reduces monitoring burden, enhances protocol compliance, and supports adaptive trial designs. Regulatory perspectives on RBM adoption and documentation requirements will also be addressed.
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Risk-Based Monitoring and Trial Optimization Conference Speakers
Recommended Sessions
- Advances in Risk Management Planning
- AI and Automation in Signal Detection
- Audits, Inspections, and PV Compliance Best Practices
- Benefit-Risk Assessment in Drug Development
- Data Integrity and Electronic Trial Master Files
- Digital Therapeutics and Safety Monitoring
- Emerging Challenges in Global Pharmacovigilance
- Ethics and Transparency in Clinical Research
- Global Regulatory Updates and Compliance Trends
- Integration of Pharmacovigilance in Drug Life Cycle
- Patient-Centric Approaches in Clinical Trials
- Pharmacovigilance in Personalized and Precision Medicine
- Pharmacovigilance in Rare and Orphan Drugs
- Pharmacovigilance in Vaccines and Biologics
- Post-Marketing Surveillance and Real-World Data
- Real-Time Safety Data Monitoring Strategies
- Risk-Based Monitoring and Trial Optimization
- Safety Reporting in Early Phase Trials
- Signal Prioritization and Management Techniques
- The Role of CROs in Clinical Trial Execution
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