Using Technology to Integrate Clinical Data Management and Clinical Operations
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The document discusses the integration of technology in clinical data management (CDM) and clinical operations, highlighting the transition from paper-based processes to electronic data capture (EDC) for improved efficiency. It emphasizes the importance of real-time data interaction and centralized monitoring to enhance trial management, reduce query resolution time, and ensure data integrity. Case studies illustrate the challenges and successes of implementing EDC, stressing the necessity for an integrated approach to fully leverage technological advancements in clinical research.
Using Technology to Integrate Clinical Data Management and Clinical Operations
- 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 Confidential –
- 3. Historical Perspectives • Drug Development Process – Paper-based processing • Electronic Data Capture – Interactive processing Confidential –
- 4. Historical Perspectives • Age of technological advances – Application of technology to a process – Integration of technology as part of the process 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 12. Confidential –
- 13. Clinical Data Management Process Driven Technology Driven Cross-Functionally Driven Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 Confidential –
- 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 –