The State of Clinical Development - Globalization

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CROs in Today's Drug Development - Douglas Peddicord January 11, 2012

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The State of Clinical Development - Globalization January 11, 2011 Doug Peddicord, PhD Executive Director

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The Top CROs (as of 10-16-11) Sources: Scrip INC Kendle Pharmanet I3 InVentiv Health

Major Pharma and CRO Clinical Headcount Source: Tufts CSDD analysis

Increasing Global Site Dispersion Source: Tufts CSDD analysis of Industry-Funded Trials Registered on clinicaltrials.gov 2002-2006 (Mean # of Countries) 2006-2010 (Mean # of Countries) Phase I Clinical Trial 2 2 Phase II Clinical Trial 11 18 Phase III Clinical Trial 19 34

A Global Enterprise – Current and Recently Completed Trials Source: ClinicalTrials.gov

Why Conduct Clinical Trials Around The World? ,[object Object],[object Object],[object Object],[object Object]

Globalization - Advantages ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Globalization - Challenges ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Globalization - Concerns ,[object Object],[object Object],[object Object],[object Object]

NBAC 2001 Report – selected recommendations ,[object Object],[object Object],[object Object],[object Object]

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Going Beyond Business Considerations and Policy Recommendations ,[object Object],[object Object]

Comparison of Participating Sites and Subjects Across Various Regions

Demographic and Other Study Details ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Assessing Global Quality at the Investigator/Site Level ,[object Object],[object Object],[object Object]

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