Looking Beyond Risk in Risk-Based Monitoring

CROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance: “A Risk-Based Approach to Monitoring.” From a practical level, how do you start your program and gain the full advantages of RBM?

Key topics of discussion include:

• Creating a sustainable RBM strategy with a common platform
• Decreasing your site visits and increasing the efficiency of oversight
• Focusing activities on preventing or mitigating risks
• Leveraging risk insights to increase the quality of trial design

This webinar focuses on a CRO implementation of the PerkinElmer RBM Solution, powered by TIBCO^® Spotfire^®, including compelling lessons and surprising insights that continue to drive trial design enhancements and optimize the CRO-sponsor partnership.

This is the last webinar in our 4-part series: “Four Steps to Shorten Your Clinical Trials with Informatics.” This series explores proven ways to develop go/no-go insights faster, so clinical development teams can:

• Get submission-ready faster
• Reduce the risk of a rejected submission or potential market withdrawal
• Optimize data provisioning, aggregation and review

Speakers

David Weinstein, Director, Data Analytics, Premier Research

David Weinstein is currently working as the Director, Data Analytics in the Data Management organization of Premier Research. He has been with the company since March of 2009. David has worked with the major Clinical and Data Management systems, such as Oracle Clinical, Datalabs, Medidata Rave, and associated data reporting tools, such as SpotFire for Risk-Based Monitoring. David has over 20 years’ experience in drug development delivering technical solutions to pharmaceutical and biotechnology companies.

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Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics

Masha Hoffey is the Director of Clinical Analytics at PerkinElmer. She has over eight years of experience with clinical and regulatory applications. She oversees the Clinical Practice, including product development and services. She also served as Head of Services and Support at Virtify, Inc. and was part of the business analysis teams at Merge Healthcare and PAREXEL International, driving clinical and regulatory metrics/reporting strategy and leading customer implementations. Ms. Hoffey holds a BA from Williams College and an MS in Regulatory Affairs for Drugs, Devices, and Biologics from Northeastern University.

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