The World Congress Summit on Risk-Based Monitoring and the Quality Risk Management of Clinical Trials

The World Congress Summit on Risk-Based Monitoring
and the Quality Risk Management of Clinical Trials

Assess, Control, Review, and Adjust Risk Across the Trial Lifecycle

QBD Protocol • Risk Assessment • Risk-Based Monitoring • Quality Auditing • Sponsor-Site Alignment

Clinical trials must be conducted more safely and efficiently if patients are to benefit from new therapies in the development pipeline. Risk management throughout the product lifecycle from the study planning phase to its conclusion enables a trial sponsor to reduce or prevent risk or lessen the severity of a harmful event. Risk-based approaches, adapted to each trial, allow the Sponsor to not only address cost, but better identify, manage and remove risk to ensure patient safety and data quality.

This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.

• Gain internal support and reach agreement on the best approach to drive your RBM strategy
• Evaluate the contribution that Source Data Verification and Review makes to clinical trial safety and quality
• Change management strategies that have led to effective RBM implementation
• Assess risk and adapt the model to de-risk each study individually
• A best practices framework for data integrity
• Use metrics to guide risk mitigation planning
• Improve connectivity between the Site and Sponsor