Implementing Risk-based Monitoring, Using Oncology Examples

Risk-based Monitoring (RBM) is a new way to facilitate more efficient trial delivery. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) provided guidance that highlights some key points, including the value of a risk assessment, identifying key data points, developing a monitoring plan with multiple considerations, appropriate use of centralized monitoring, and leveraging new technology capabilities.

Quintiles has executed studies using RBM policies and procedures for many years, including over 80 studies, 20,000 sites and 200,000 patients, including nine Oncology studies. So when some major US pharma companies wanted to develop a RBM approach to clinical monitoring for their Oncology studies, they turned to Quintiles for the right mix of on-site and remote monitoring, a centralized and ongoing data review process with reduced SDV based on risk assessments, and technology with key triggers and alerts. The presenters will share examples of delivering effective programs that achieved greater resource efficiencies and improved data quality nearly twofold better than industry benchmarks.

Teresa Lamantia, Vice President, Strategic Operations, Quintiles, a global leader for Quintiles RBM strategy, will discuss her RBM insights and recommendations based on Quintiles experience.

Alexandra Massoud, Director of Clinical Operations, Quintiles will share insights from working directly on oncology studies, including the amount of onsite time required, the need for a comprehensive risk assessment and data management plan, and implementing a monitoring plan that takes satellite sites into account.

In this webinar, the presenters will cover how:

• Quality-by-design helps focus efforts on the high risk areas
• Monitoring is evolving based on the amount of risk presented
• Technology has evolved to support decisions and actions that affect trial outcomes
• Operating models, work roles, and data flow are evolving to be more efficient.

Speakers

Teresa Lamantia, Vice President, Strategic Operations Quintiles

Teresa is responsible for setting the global strategy for clinical services and for driving operational improvement and innovative business model development at Quintiles. She is the global lead for Quintiles Risk-based Monitoring Strategy and has provided numerous consultations to customers and helped lead the build of RBM strategies for several key accounts. Prior to this role she was the head of North America and Latin America Global Functional Resourcing. She joined Quintiles in 2002 and earned a BSN from Vanderbilt University and an MSN from the University of Cincinnati.

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Alexandra Massoud, Director of Clinical Operations, Quintiles

Alexandra Massoud is Director of Clinical Operations at Quintiles. She currently works with Data-driven Trial Execution (DTE) set up and delivery with a focus on site monitoring. She has been working with DTE and risk-based monitoring models since 2012, partnering with customers and global teams to implement RBM strategies. She has held various management positions since joining Quintiles in 2008. Prior to her tenure at Quintiles, she was a CRA at Amgen for 9 years with increasing levels of responsibility. She is home-based in Chicago, IL.

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