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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