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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