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Innovated Supply Chain Management: Efficiencies and Cost Reduction in Clinical Trials

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Chris Wilke, CTO at DATATRAK Int., presented on Innovated Supply Chain Management: Efficiences and Cost Reduction in Clinical Trails at the DIA's 23rd Annual EuroMeeting on March 30, 2011 in Geneva, …

Chris Wilke, CTO at DATATRAK Int., presented on Innovated Supply Chain Management: Efficiences and Cost Reduction in Clinical Trails at the DIA's 23rd Annual EuroMeeting on March 30, 2011 in Geneva, Switzerland


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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
      Chris Wilke
      Chief Technology Officer
      DATATRAK
      23rd Annual
      EuroMeeting
      28-30 March 2011
      Geneva, Switzerland
    • 2. 2
      Disclaimer
      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.
       
      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.
    • 3. Agenda
      Review typical challenges
      Investigate an innovative approach
      Discuss case studies
      3
    • 4. Life Sciences Product Development
      Rewarding + Invigorating + Satisfying
      4
    • 5. Life Sciences Product Development
      Challenging + Costly
      5
    • 6. Our Challenge
      Efficiency
      Cost
      6
    • 7. Laden with Integrated Silos
      7
    • 8. Redundant Processes
      8
    • 9. Lost Time
      Inhibit Decisions
      9
    • 10. Separate Data
      10
    • 11. Separate Data Challenges
      Poor visibility
      Elongated timelines
      Lack of accountability
      Data invisible until process end
      11
    • 12. Is there a better way?
      12
    • 13. Yes. We can leverage our EDC investment.
      13
    • 14. EDC can unlock this…
      14
    • 15. Unified Data
      15
    • 16. Benefits
      Data are visible during trial
      Direct export to analysis set
      Visibility of data management
      16
    • 17. IBM wrote a paper on it.
      17
    • 18. The FDA has draft guidance on it.
      18
    • 19. Case Study 1
      Phase III Double-Blind Dose-Escalation
      19
    • 20. Dose Escalation Challenges
      20
      4 different drugs
      Complex escalation criteria for each drug
      Kit-based supply
      Unevenly scheduled visits (16 kit types)
      Investigator decision
    • 21. Which 16 kits do we ship?
      How many of each kit?
      And when?
      21
    • 22. Optimal Supply Chain Factors
      22
    • 23. Data Required to Optimize
      EDC
      Patient demographics
      Patient visit vitals
      Central Lab
      Key lab values
      Randomization
      Treatment assignment
      Drug Supply
      Drug inventory
      23
    • 24. Optimized Solution
      Delay shipments based on visit schedule
      Delay shipments based on escalation
      Shipment size based on site enrolment
      Escalation options restricted to protocol
      Combine shipments to reduce costs
      All events triggered by eCRF input
      24
    • 25. Case Study 2
      Phase II Double-Blind
      25
    • 26. Challenges
      26
      4-year study
      Controlled substance drug
      Cost to ship was very high
      Multiple dose levels
      Initial supply lasts 120 days
    • 27. Data Required to Optimize
      EDC
      Number of active patients
      Patient demographics
      Randomization
      Multiple patient doses
      Patient dose level
      EDC Visit Schedule
      Number of visits in next 120 days
      Drug Supply
      Site inventory levels
      27
    • 28. Optimized Solution
      System performs 120-day Inventory Evaluation
      Number of enrolled patients
      Multiple patient doses
      Number of visits in the next 120 days
      Site inventory levels
      System determines how many additional vials are required for each site over the next 120-day period
      28
    • 29. Summary
      Traditional data collection works
      Unified data is a growing trend
      Unified data unlocks optimization
      29
    • 30. Questions?
      chris.wilke@datatrak.net
      30