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…excellence through understanding The Impact of EDC on Contract Research Organisations, Current Monitoring and Site Roles Birant Osman MSc Group Manager,

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Presentation on theme: "…excellence through understanding The Impact of EDC on Contract Research Organisations, Current Monitoring and Site Roles Birant Osman MSc Group Manager,"— Presentation transcript:

1 …excellence through understanding The Impact of EDC on Contract Research Organisations, Current Monitoring and Site Roles Birant Osman MSc Group Manager, Statwood

2 …excellence through understanding Objective The Impact of EDC on –Small and medium sized Contract Research Organisations (CROs) –Monitoring practices –Sites –Possible resolutions

3 …excellence through understanding CRO Perspective Increase of paper studies for CROs from pharmaceutical companies Staff training –Cost –Time

4 …excellence through understanding CRO Perspective cont System support – Monitors – Sites Which system – Existing System – Develop a new in-house system

5 …excellence through understanding Monitors perspective Changes in monitoring practice –Decreased travel –More site interaction –Less time spent at site –Increased workload at Study start up

6 …excellence through understanding Monitors perspective cont Changes in monitoring practice –Decreased workload at Study end –Training issues –Change to IT support role

7 …excellence through understanding Monitor/Site Interactions Change in Monitor role from site perspective –Less Face-to-Face contact –Less time in office space –Increase use of phone

8 …excellence through understanding Monitor/Site Interactions cont Change in Monitor role from site perspective –Less frequent visits –Change in type of questions for monitor

9 …excellence through understanding Site Perspective Nothing to write on –No storage problems Computer literacy Security Training

10 …excellence through understanding Site Perspective Cont Live data Non-specific IT issues PC Hardware / Software Cost

11 …excellence through understanding Conclusion Changing roles –C–CROs –M–Monitors –I–Investigators and site personnel Mainly Start-up issues All these issues can be resolved with –P–Pre-emptive planning –C–Careful site selection –U–Use of CDISC

12 …excellence through understanding Questions? For more information contact: +44 (0)


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