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An SMO is Not a CRO, Or is It - When It Comes to Bio Medical Research Monitoring

An SMO is Not a CRO, Or is It - When It Comes to Bio Medical Research Monitoring

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Published by: Artscience on Nov 02, 2009
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05/14/2010

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Why a SMO is not a CRO,or is it?
Stan W. Woollen
Associate Director for Bioresearch MonitoringOffice for Good Clinical Practice,Office of the CommissionerFDAOct. 2001
 
 
A regulator’s perspective onCROs/SMOs
Today’s Clinical Trial Environment
 – Environmental pressures driving evolutionary changes – Identifying the different species and their place in the new environment
CRO vs. SMO - A new species
 – Similarities and differences – Regulatory issues
 
 
Today’s Clinical Trial Environment
 Pressures for change
Increased competition for subjects and investigators
 – 
Large trials widely dispersed geographically over many sites
 – 
Influx of new Clinical investigators
 – 
Principal investigators remote to sites
Increased need for speed
 – 
Remote data collection and electronic transmission
 – 
Central IRBs and study monitoring
Increased reliance on contractors (e.g. CROs/SMOs)
 – 
greater fragmentation in dispersing study functions

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