Site Quality Management to Optimize Risk-Based and Centralized Monitoring

In today’s clinical development environment, the quest for improved data quality at a lower cost is of paramount importance to all research organizations. Given that monitoring represents upwards of 30% of the cost of a clinical trial, a risk-based model for monitoring has become a growing and crucial component in this search, and recent FDA guidance has lent further support for this paradigm. This webinar will break down the issues related to the implementation and tracking of a risk-based monitoring program through the utilization of site quality management as well as the process and organizational challenges of adopting site quality management and centralized monitoring.

Key learning points of the webinar:

• Learn the role of data quality and metrics in the adoption of risk-based monitoring
• Interpret regulatory agencies’ guidance on risk-based monitoring
• Address challenges in adopting a risk-based approach
• Understand the concepts underpinning a site quality management program
• Hear detailed guidance on what’s needed in terms of organizational support and process change to implement risk-based monitoring with centralized site quality management

Speakers

Steve Young, Senior Product Director, Medidata Solutions

Stephen Young is Senior Product Director at Medidata Solutions Worldwide. Stephen brings more than 15 years of experience in driving change and implementing technologies within clinical development organizations, most recently as head of eClinical Services for J&J Global Clinical Operations. In his current role, Stephen leads Medidata’s Monitoring solution set, which includes Medidata Insights™ SQM, the industry’s first turnkey site quality management solution. Stephen received his BSc in Mathematics from St. Joseph’s University and his MA in Mathematics from Villanova University.

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Laurie Halloran, President, Halloran Consulting Group

Laurie Halloran is the President of Halloran Consulting Group. Laurie founded Halloran Consulting Group in 1998. With over 25 years of experience in clinical affairs management with contract research organizations and biotechnology companies, Laurie is recognized as an industry expert in improving the organizational effectiveness of global development with specialties in gap analysis and actionable solutions for optimization. Laurie has experience managing clinical trials from Phase I to Phase III for both emerging and established companies and has managed operational budgets of up to $24 MM. She is an adjunct professor at Boston University Medical School and is also a Prosci certified change management consultant.

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