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Clarion Hotel Dublin City

Oct 08, 2013 9:00 AM - Oct 09, 2013 5:30 PM

Excise Walk, IFCS, Dublin 1, Ireland

7th Annual Clinical Forum - Rebooting Clinical Development

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RISK-BASED MONITORING – PART II

Session Chair(s)

Julianne Hull, MS

Julianne Hull, MS

CEO

WenStar Enterprises, United Kingdom

Monitoring accounts for up to 30% of the total cost of a trial. Traditionally interpreted as 100%SDV & on-site-monitoring,newer,so-called risk based approaches,offer the potential to significantly reduce costs while maintaining data quality &safety

Learning Objective : Participants will learn about the essentials of risk based monitoring, what needs to be considered when switching from traditional monitoring to a risk based approach and what the challenge are that need to be overcome when establishing a risk based monitoring approach, especially when deciding how to deploy your monitors!

Speaker(s)

A holistic approach to Monitoring Clinical Trials

Peter Schiemann, PhD, MBA

Widler & Schiemann Ltd, Switzerland

Managing Partner

Erik Doffagne, MS

Identifying Atypical Sites with Central Statistical Monitoring

Erik Doffagne, MS

CluePoints, Belgium

Product Manager

Lessons from Risk-Based Monitoring

Joshua Pines, MBA

Medidata, a Dassault Systemes Company, United Kingdom

Director EMEA Marketing

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