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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
Copyright:Attribution Non-commercial


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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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