Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs
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This presentation discusses Oracle Clinical Development Analytics (CDA), a clinical data warehouse and reporting solution. CDA combines data from clinical trial management systems and electronic data capture systems. It includes pre-built interactive dashboards and reports. The presentation covers how CDA can be used by clinical operations and data management, how to create new reports and dashboards, CDA's architecture, ways to extend CDA, and services provided by BioPharm to support CDA implementation and customization.
Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs
- 1. Copyright BioPharm Systems, Inc. 2009. All rights reserved Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs Mike Grossman VP Clinical Warehousing and Analytics
- 2. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and Answers
- 3. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and answers
- 4. Clinical Development Analytics • Clinical Development Analytics (CDA) is an extensible warehouse and reporting solution that supports Clinical Operations and Clinical Data Management • CDA combines data from CTMS and EDC/CDMS • CDA incudes pre-packaged interactive dashboards and reports • CDA includes a data warehouse optimized for understanding the running of trials
- 5. CDA Pre-Built Content • Clinical Data Management –Covering both EDC and Paper processes • 26 pre-packaged reports –Primary Data Source • Oracle Clinical / Oracle Remote Data Capture • Clinical Operations –Covering Screening and Recruitment, Retention and Document Management • 24 pre-packaged reports –Primary Data Source • Siebel Clinical • 369 pre-built measures & attributes –Operational metrics such as # eCRFs Approved, # Subjects Enrolled –Supporting attributes such as Study Name, Site Name
- 7. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and answers
- 8. Study Site Start Up - Overview
- 9. Study Site Start Up – What’s In Place Before Site Start Up?
- 10. Study Site Enrollment – How is Enrollment Going?
- 11. Study Enrollment -Too Many Screen Failures?
- 12. What’s the Status of eCRF Entry and Approval?
- 13. Is My Data Clean?
- 14. What’s Going on With Early Terminations?
- 15. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and answers
- 16. How Do I Create A New Report?
- 17. Pick Your Data Points
- 18. Look at the Results and Save
- 19. Add Some Graphical Displays
- 20. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and answers
- 21. CDA’s Pre-Built Clinical Warehouse Ad-hoc Analysis Interactive Dashboards Proactive Alerts MS Office Integration Oracle BI Enterprise Edition Plus Integrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMS CDA Informatica SIL ETL CDA Clinical Warehouse Schemas CDA Staging Tables Oracle Clinical Seibel Clinical CDA Informatica SDE ETL Duration of Open Discrepancies iPhone Integration Note: SDE (Source Dependant Extract) / SIL (Source Independent Load) This Slide is from Oracle Corp.
- 22. Holistic Reference, Clinical IT Reference Architecture Outcomes Common Data Model Project level Conformed Data Value Added Study Data Conformed Study Data Operational Trial Metrics Inbound Data Sources Master Meta Data AES & Complaints Outcomes External Study Data LIMS/PK Central Labs CDMS/ EDC CTMS Staging Area AES & Complaints Source Specific Outcomes Data Shared Study and Project Meta Data Study Specific Data Staging Trials Management Warehouse Area Specialized Data Marts for Scientific Exploration and Mining Specialized Data Marts for Scientific Exploration and Mining Specialized Data Marts for Scientific Exploration and Mining Patient Sub Setting and Safety Warehouse Clinops Data Marts Meta Data Libraries, Version Control, Compliance Change Mgt Ad-Hoc Query Dashboards Structured Reports Analytical Tools Strategic Analysis Regulatory Reporting Data Mining Clinical Developmen t Planning
- 23. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and Answers
- 24. OCDA Speed Time to Value and Lower Total Cost of Ownership Compared with Traditional Tools Pre-built Data Warehouse design, adapts to enterprise data Build from Scratch with Traditional Tools Oracle Analytics Applications Months Back-end ETL and Mapping Data Warehouse Design Define Metrics & Dashboards Back-end ETL and Mapping Data Warehouse Design Define Metrics & Dashboards Training/Roll-out Training/Rollout Quarters or Years Sources: Patricia Seybold Research, Gartner, Merrill Lynch, Oracle Analysis Pre-built business adapters for Clinical Applications Role-based dashboards and hundreds of pre-defined metrics Easy to use, easy to adapt • Faster deployment • Lower TCO • Assured business value This Slide is from Oracle Corp.
- 25. How Can CDA Be Extended? • Add to dimensions and facts, attributes, and measures • Use only Oracle Clinical or Siebel Clinical • Supplement with data from other systems and warehouses such as Oracle BAW or SAP • Supplement with external data (CRO, Sponsor, Partner) • Combine with other clinical content, such as subject data • Replace a source system with one or more solutions. For example, home grown CTMS for SC or Inform for OC • Supplement OBIEE with other reporting tools such as Spotfire
- 26. CDA Inside Siebel Clinical
- 27. BioPharm Services for Integration and Analytics • Business case development and cost analysis • Requirements and design management • Best practice analysis and recommendations • Installation and configuration • Oracle CDA and LSH pilots and proofs of concept • Hosting • Oracle CDA and LSH implementation • CDA and LSH validation • CDA and LSH training • CDA and LSH extension development
- 28. Agenda • Oracle Clinical Development Analytics • Working with CDA and Clinical Operations and Clinical Data Management • Creating new reports and dashboards • CDA Architecture • Extending CDA • Questions and Answers
- 29. Contact Information If you have additional questions please contact: United States: +1 877 654 0033 United Kingdom: +44 (0) 1865 910200 Email Address: info@biopharm.com Website: www.biopharm.com