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Observational Studies: Strategic, Operational and Budgetary Considerations

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Observational Studies: Strategic, Operational and Budgetary Considerations - Trotter_1-11-2012

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Observational Studies: Strategic, Operational and Budgetary Considerations 11 January 2011 Jeff Trotter – Executive Vice President – Phase IV Development
Post-approval research today – Safety and value ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Real world perspectives Real world research “ The conditions under which products are examined for regulatory approval are generally not the conditions under which they are actually used
”
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Real world (observational) studies are needed, because

Different conditions require different processes
Operational Issues and Challenges ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Observational Studies are a “different animal” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CRO Proposal Product Management, HEOR Clin Ops RFP/Bid Grid Outsourcing
Highlights from survey on Observational Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Observational Research: Budgetary Implications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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