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Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program


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Presentation discusses: …

Presentation discusses:
The Drug Development Process
The Drug Development Paradox
Regulations and Guidelines
Standards - CDISC
Leveraging Technology
Resource Management

Published in: Technology, Business
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  • 1. Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program Presented to DIA-Japan: 31 January 2014 William Gluck, Ph.D.
  • 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, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of Confidential – 2
  • 3. Agenda 1. The Drug Development Process 2. The Drug Development Paradox 3. Regulations and Guidelines 4. Standards – CDISC 5. Leveraging Technology 6. Resource Management Confidential – 3
  • 4. Overview – The Drug Development Process Confidential – 4
  • 5. The Clinical Trial Paradox Leverage technology and process to conduct trials faster and obtain quicker approvals With speed and more interaction comes a greater risk of error Confidential – 5
  • 6. Combined Human Interaction and Speed in the Clinical Trial Process… Potential for Error = Increased Risk Downstream Data Quality at Risk Over time, seemingly insignificant errors accumulate, significantly Discovery increasing risk 10 years Confidential – 6 Clinical Pre-Clinical 3.5 years 6.5 years
  • 7. How can we reduce the time needed to conduct studies and also reduce risk?  Regulations & Guidelines  Standards - CDISC  Leveraging Technology  Resource Management Confidential – 7
  • 8. Regulations and Guidelines Help to Accelerate Drug Development and Reduce Risk ICH FDA GCP Standardized Data and Process Confidential – 8
  • 9. Standards CDISC CDASH Confidential – 9 ODM STDM AdAM SHARE
  • 10. Leveraging Technology
  • 11. The Integrated Approach EDC Randomization Central Database Coding Data must be moved in order to create the central database – increases risk of errors Confidential –11
  • 12. The Unified Approach Central Database EDC Coding Randomizatio n Reduces risk 12 Confidential –
  • 13. Resource Management
  • 14. Key Roles and Responsibilities Clinical R&D Leadership Clinical Study Team CRA/Site Quality Manager Data Management 14 Confidential – • Overall support and guidance • Develop Study-specific/Development Plan • Centrally monitor quality across all sites – identify emerging issues • Coordinate/track and follow-up • Data Management Plan – Targeted & Aligned • EDC configuration as a key enabler • Global Data and System Management
  • 15. Inter-Relationships • Clinical R&D • Clinical Study Team Regulations Resources • CRA Standards Technology • CDM Using the Unified Platform – Everything in one place 15 Confidential –
  • 16. Utilizing All Resources Standards Technology Resources Central Data Repository 16 Confidential –
  • 17. Real Life Example: Value of the Central Repository and Unified Platform ► Drug A: Generation of the ISS and ISE • Different vendors, databases, standards • Time duration: 10 months to generate ► Drug B: Generation of the ISS and ISE • • • • 17 Confidential – Different CRO vendors for Phase I Single vendor, single platform database for Phase II and Phase III studies Standards enforced (but not CDISC) Time duration: 4 months to generate
  • 18. Summary How can we reduce the time needed to conduct studies and also reduce risk? • Leverage Regulations and Standards • Leverage Technology – Reduce Movement by • 18 Confidential – using a Unified Platform Leverage Resources – Adjust Roles to Maximize Effectiveness
  • 19. William Gluck, Ph.D. VP, DATATRAK Clinical Knowledge DATATRAK Phone: 440-443-0082 x114 E-Mail: 19 Confidential –
  • 20. from Concept to Cure with D ATATRAK ONE ® ™ DATAT R A K International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free