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Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
Diaeurope2011 110413093716 Phpapp01
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Diaeurope2011 110413093716 Phpapp01

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On SlideShare - Chris Wilke, DATATRAK\'s CTO, presents "Innovative Supply Chain Management" at the 23rd Annual DIA EuroMeeting

On SlideShare - Chris Wilke, DATATRAK\'s CTO, presents "Innovative Supply Chain Management" at the 23rd Annual DIA EuroMeeting

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  • 2 randomized in 1:1 ratio and 2 open label to be given at 2 different dosesVaried visit timingLeads to different kit types that need to be available
  • Unified data allows to optimize supply chain management
  • 2 randomized in 1:1 ratio and 2 open label to be given at 2 different dosesVaried visit timingLeads to different kit types that need to be available
  • Unified data allows to optimize supply chain management
  • Transcript

    • 1. Innovative Supply Chain Management Efficiencies and Cost Reduction in Clinical Trials <br />Chris Wilke<br />Chief Technology Officer<br />DATATRAK<br />23rd Annual<br />EuroMeeting<br />28-30 March 2011<br />Geneva, Switzerland<br />
    • 2. 2<br />Disclaimer<br /> The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. <br /> <br /> These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. <br />
    • 3. Agenda<br />Review typical challenges<br />Investigate an innovative approach<br />Discuss case studies<br />3<br />
    • 4. Life Sciences Product Development<br />Rewarding + Invigorating + Satisfying<br />4<br />
    • 5. Life Sciences Product Development<br />Challenging + Costly<br />5<br />
    • 6. Our Challenge<br />Efficiency<br />Cost<br />6<br />
    • 7. Laden with Integrated Silos<br />7<br />
    • 8. Redundant Processes<br />8<br />
    • 9. Lost Time<br />Inhibit Decisions<br />9<br />
    • 10. Separate Data<br />10<br />
    • 11. Separate Data Challenges<br />Poor visibility<br />Elongated timelines<br />Lack of accountability<br />Data invisible until process end<br />11<br />
    • 12. Is there a better way?<br />12<br />
    • 13. Yes. We can leverage our EDC investment.<br />13<br />
    • 14. EDC can unlock this…<br />14<br />
    • 15. Unified Data<br />15<br />
    • 16. Benefits<br />Data are visible during trial<br />Direct export to analysis set<br />Visibility of data management<br />16<br />
    • 17. IBM wrote a paper on it.<br />17<br />
    • 18. The FDA has draft guidance on it.<br />18<br />
    • 19. Case Study 1<br />Phase III Double-Blind Dose-Escalation<br />19<br />
    • 20. Dose Escalation Challenges<br />20<br />4 different drugs<br />Complex escalation criteria for each drug<br />Kit-based supply<br />Unevenly scheduled visits (16 kit types)<br />Investigator decision<br />
    • 21. Which 16 kits do we ship?<br />How many of each kit?<br />And when?<br />21<br />
    • 22. Optimal Supply Chain Factors<br />22<br />
    • 23. Data Required to Optimize<br />EDC<br /> Patient demographics<br /> Patient visit vitals<br />Central Lab<br /> Key lab values<br />Randomization<br /> Treatment assignment<br />Drug Supply<br /> Drug inventory<br />23<br />
    • 24. Optimized Solution<br />Delay shipments based on visit schedule<br />Delay shipments based on escalation<br />Shipment size based on site enrolment<br />Escalation options restricted to protocol<br />Combine shipments to reduce costs<br />All events triggered by eCRF input<br />24<br />
    • 25. Case Study 2<br />Phase II Double-Blind<br />25<br />
    • 26. Challenges<br />26<br />4-year study<br />Controlled substance drug<br />Cost to ship was very high<br />Multiple dose levels<br />Initial supply lasts 120 days<br />
    • 27. Data Required to Optimize<br />EDC<br />Number of active patients<br />Patient demographics<br />Randomization<br /> Multiple patient doses<br /> Patient dose level<br />EDC Visit Schedule <br /> Number of visits in next 120 days<br />Drug Supply<br /> Site inventory levels<br />27<br />
    • 28. Optimized Solution<br />System performs 120-day Inventory Evaluation<br />Number of enrolled patients<br />Multiple patient doses<br />Number of visits in the next 120 days<br />Site inventory levels<br />System determines how many additional vials are required for each site over the next 120-day period<br />28<br />
    • 29. Summary<br />Traditional data collection works<br />Unified data is a growing trend<br />Unified data unlocks optimization<br />29<br />
    • 30. Questions?<br />chris.wilke@datatrak.net<br />30<br />

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