Historical Perspectives Integrating Clinical Operations Integrating Clinical Data Management Case Study Examples Conclusions and Parting Thoughts

1. Using Technology to Integrate Clinical
Data Management and Clinical Operations
William Gluck, PhD
VP, DATATRAK Clinical and Consulting Services
Presented to ACDM
March 18-19, 2013

2. Agenda
• Historical Perspectives
• Integrating Clinical Operations
• Integrating Clinical Data Management
• Case Study Examples
• Conclusions and Parting Thoughts
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3. Historical Perspectives
• Drug Development Process
– Paper-based processing
• Electronic Data Capture
– Interactive processing
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4. Historical Perspectives
• Age of technological advances
– Application of technology
to a process
– Integration of technology
as part of the process
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5. Confidential –

6. Clinical Operations: The Past!
• On-site monitoring was an isolated event and the only way
• Trial management done on paper
• Monitoring focus was on data checking
• 100% SDV was implied
• Monitored CRF “handoff” to CDM
………………Very paper and process intensive and slow
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7. Using Technology to Change Processes
• Need changes in processes of:
– Collection, monitoring, tracking, cleaning
• Real time data processing requires real time
interaction between Clinical Operations and CDM
• CRF design including protocol deviations and edit
checks require both Clinical Operations and CDM
• Query process is more real time and interactive
between Clinical Operations and CDM for
immediate changes
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8. Technology Influenced Process Change
• Real time monitoring
• Data can be reviewed off-site
• Continuous data flow from Clinical Operations to CDM (and
other functional groups)
• CRF design with Clinical Operations and CDM
– Includes protocol compliance
– Edit checks to reduce queries
– Database designed early requiring earlier data decisions
• Sequential processes become simultaneous
• Silo monitoring processes become integrated with CDM
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9. CTMS Further Enhances Efficiency
• Leverages technology in assembling, organizing, and
reviewing the study set-up process
• Provides up-to-date study metrics
• Facilitates payments
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10. FDA Draft Guidance
• Risk Based monitoring
• Centralized (off-site) monitoring is encouraged!
• Centralized monitoring suggested to replace on-site
monitoring when it can complete activities better or as well
as on-site
• Centralized monitoring (when appropriate) should improve
ability to ensure the quality and integrity of data
– Publications suggest that data anomalies may be more readily detected
• EDC applications can implement centralized monitoring
methods that enable decreased reliance on on-site monitoring
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11. Monitoring in the 21st Century
• Risk based monitoring
• Centralized monitoring
• Continual interaction with Site
• SDV% will vary
• Monitor spends more time on overall study management
• Continuous data flow to and from other functional areas
• Immediate query resolution with feedback decreases
monitoring time
• Continual interaction with CDM from CRF design
through monitoring to database lock
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12. Confidential –

13. Clinical Data Management
Process Driven
Technology Driven
Cross-Functionally Driven
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14. CDManagement
• Technology and EDC is not just a CDM tool
• Benefits extend to all functional areas
• Integration and Technology allow for companies to
put the MANAGEMENT back in Clinical Data
Management
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15. Technology as an Integration Tool
• Technology poses no functional constraints
– Forces process re-evaluation
• Workflow bring Clinical Operations
and CDM closer together
• Groups compliment and build
upon each other – seamlessly and
without formal handoffs
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16. A Case Study – Using EDC
• Company A had a small clinical operations group
with offices next to the CDM and rest of the
Biometrics Department
• Paper-based data collection – time from last patient
to database freeze/lock was approximately 4 weeks
for a ‘typical’ Phase II study
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17. A Case Study – Using EDC
• EDC decision made at Management-level
• Top-down implementation
• No process re-evaluations or changes
• Study protocol in a state of flux
• Costs for EDC builds over $300K and not in
production – EDC deemed a disaster
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18. A Case Study - EDC
• Same teams 2 years later – CDM pro-EDC but
Clinical Operations showing resistance to EDC
• Internal process evaluation/realignment
• Workflow changes implemented
• EDC application implemented across functional areas
with cross-functional involvement
• EDC
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19. Conclusions
• Use of technology is a great advancement but we
need to assimilate it into re-engineered processes
• To gain maximum benefit, we must approach
implementation of any technology through an
integrated approach
• Tools such as CTMS and using technology to
leverage risk-based monitoring approaches can
further optimize the overall process
• Technology, like an EDC application, can bring
together groups traditionally separated by process
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20. William Gluck, Ph.D.
VP, DATATRAK Clinical and Consulting Services
Datatrak International, Inc.
Phone: 919-651-0222
Cell: 919-522-9681
E-Mail: Bill.Gluck@datatrak.net
Confidential –