Beyond COVID-19: The New Normal in Risk Based Monitoring and Quality Management
Nick May, Sr. Director Risk Based Monitoring, Parexel
Steve Young, Chief Scientific Officer, CluePoints
Please join this webinar to learn first-hand how the Parexel and CluePoints partnership is driving best in class Risk-Based Quality Management strategies to support clinical development. This session will focus on how early risk detection can be leveraged to detect issues across your trial and ensure operational excellence. As the COVID-19 pandemic continues, actions need to be prioritized to combat the disruption to in-flight trials. We believe the challenge of identifying and actioning these critical issues in a timely manner will be the catalyst in driving the adoption of central / remote monitoring going forward. We will share best practices for today and future.
Key areas of insights:
- Enhanced data quality oversight and regulatory compliance
- Proactive risk management to protect patient safety
- Driving the quality, accuracy, and integrity of clinical trial data
- Increased productivity, efficiency and cost effectiveness for sponsors
About the Sponsors
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. Headquartered near Boston, Massachusetts and in Durham, North Carolina, and supporting clients in more than 100 countries, our almost 20,000 employees are united by one simple fact. We care. We’re not just the people with brains, we’re the people with heart.
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Its products utilize comprehensive statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based Quality Management (RBQM) strategy in all trials.For more information please visit www.parexel.com/.