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

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

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

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

…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

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

…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

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

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

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

…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

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