Post on 28-Mar-2015
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The Impact of EDC on Contract Research Organisations, Current
Monitoring and Site Roles
Birant Osman MSc
Group Manager, Statwood
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Objective
• The Impact of EDC on
– Small and medium sized Contract Research Organisations (CROs)
– Monitoring practices– Sites– Possible resolutions
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CRO Perspective
• Increase of paper studies for CROs from pharmaceutical companies
• Staff training– Cost– Time
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CRO Perspective cont
• System support– Monitors– Sites
• Which system– Existing System– Develop a new in-house system
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Monitors perspective
• Changes in monitoring practice
– Decreased travel– More site interaction– Less time spent at site– Increased workload at Study start up
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Monitors perspective cont
• Changes in monitoring practice
– Decreased workload at Study end– Training issues– Change to IT support role
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Monitor/Site Interactions
• Change in Monitor role from site perspective
– Less Face-to-Face contact– Less time in office space– Increase use of phone
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Monitor/Site Interactions cont
• Change in Monitor role from site perspective
– Less frequent visits– Change in type of questions for
monitor
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Site Perspective
• Nothing to write on– No storage problems
• Computer literacy
• Security
• Training
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Site Perspective Cont
• Live data
• Non-specific IT issues
• PC Hardware / Software
• Cost
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Conclusion
• Changing roles– CROs– Monitors– Investigators and site personnel
• Mainly Start-up issues• All these issues can be resolved with
– Pre-emptive planning– Careful site selection– Use of CDISC
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Questions?
For more information contact:
• Birant.Osman@statwood.com• Jason.Liew@statwood.com• +44 (0) 1462 44 00 84