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Using Technology to Integrate Clinical Data Management and Clinical Operations


Historical Perspectives …

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

Published in Technology
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  • 1. Using Technology to Integrate ClinicalData 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 ThoughtsConfidential –
  • 3. Historical Perspectives • Drug Development Process – Paper-based processing • Electronic Data Capture – Interactive processingConfidential –
  • 4. Historical Perspectives • Age of technological advances – Application of technology to a process – Integration of technology as part of the processConfidential –
  • 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 slowConfidential –
  • 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 changesConfidential –
  • 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 CDMConfidential –
  • 9. CTMS Further Enhances Efficiency • Leverages technology in assembling, organizing, and reviewing the study set-up process • Provides up-to-date study metrics • Facilitates paymentsConfidential –
  • 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 FDA Draft Guidance • Risk Based monitoring • Centralized (off-site) monitoring is encouraged!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 monitoringConfidential –
  • 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 lockConfidential –
  • 12. Confidential –
  • 13. Clinical Data Management Process Driven Technology Driven Cross-Functionally DrivenConfidential –
  • 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 ManagementConfidential –
  • 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 handoffsConfidential –
  • 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 studyConfidential –
  • 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 disasterConfidential –
  • 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 • EDCConfidential –
  • 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 processConfidential –
  • 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.netConfidential –