Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs

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Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs

  1. 1. Copyright  BioPharm Systems, Inc. 2009. All rights reservedLeveragingOracles ClinicalDevelopment Analyticsto Boost Productivityand Reduce CostsMike GrossmanVP Clinical Warehousing andAnalytics
  2. 2. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and Answers
  3. 3. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and answers
  4. 4. Clinical Development Analytics• Clinical Development Analytics (CDA) is anextensible warehouse and reporting solution thatsupports Clinical Operations and Clinical DataManagement• CDA combines data from CTMS and EDC/CDMS• CDA incudes pre-packaged interactivedashboards and reports• CDA includes a data warehouse optimized forunderstanding the running of trials
  5. 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 DocumentManagement• 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
  6. 6. CDA Pre-Built Reports
  7. 7. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and answers
  8. 8. Study Site Start Up - Overview
  9. 9. Study Site Start Up – What’s In PlaceBefore Site Start Up?
  10. 10. Study Site Enrollment – How isEnrollment Going?
  11. 11. Study Enrollment -Too Many ScreenFailures?
  12. 12. What’s the Status of eCRF Entry andApproval?
  13. 13. Is My Data Clean?
  14. 14. What’s Going on With EarlyTerminations?
  15. 15. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and answers
  16. 16. How Do I Create A New Report?
  17. 17. Pick Your Data Points
  18. 18. Look at the Results and Save
  19. 19. Add Some Graphical Displays
  20. 20. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and answers
  21. 21. CDA’s Pre-Built Clinical WarehouseAd-hoc Analysis Interactive Dashboards Proactive Alerts MS OfficeIntegrationOracle BI Enterprise Edition PlusIntegrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMSCDA InformaticaSIL ETL CDA Clinical WarehouseSchemasCDA Staging TablesOracle Clinical Seibel ClinicalCDA InformaticaSDE ETLDuration of Open DiscrepanciesiPhoneIntegrationNote: SDE (Source Dependant Extract) / SIL (Source Independent Load)This Slide is from Oracle Corp.
  22. 22. Holistic Reference, Clinical IT ReferenceArchitectureOutcomesCommon DataModelProject levelConformed DataValue AddedStudy DataConformed StudyDataOperational TrialMetricsInboundDataSourcesMaster Meta DataAES & ComplaintsOutcomesExternal StudyDataLIMS/PKCentral LabsCDMS/ EDCCTMSStagingAreaAES & ComplaintsSource SpecificOutcomes DataShared Study andProject MetaDataStudy SpecificData StagingTrialsManagementWarehouseAreaSpecialized DataMarts forScientificExploration andMiningSpecialized DataMarts forScientificExploration andMiningSpecialized DataMarts forScientificExploration andMiningPatient SubSetting andSafetyWarehouseClinops DataMartsMeta Data Libraries, Version Control, Compliance Change MgtAd-Hoc Query Dashboards Structured Reports Analytical ToolsStrategicAnalysisRegulatoryReportingData MiningClinicalDevelopment Planning
  23. 23. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and Answers
  24. 24. OCDA Speed Time to Value and Lower Total Cost ofOwnership Compared with Traditional ToolsPre-built Data Warehouse design,adapts to enterprise dataBuild from Scratchwith Traditional ToolsOracle AnalyticsApplicationsMonthsBack-endETL andMappingData WarehouseDesignDefine Metrics& DashboardsBack-endETL andMappingData WarehouseDesignDefine Metrics& DashboardsTraining/Roll-outTraining/RolloutQuarters or YearsSources: Patricia Seybold Research, Gartner, Merrill Lynch, Oracle AnalysisPre-built business adapters forClinical ApplicationsRole-based dashboards andhundreds of pre-defined metricsEasy to use, easy to adapt• Faster deployment• Lower TCO• Assured business valueThis Slide is from Oracle Corp.
  25. 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 warehousessuch 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. Forexample, home grown CTMS for SC or Inform for OC• Supplement OBIEE with other reporting tools such asSpotfire
  26. 26. CDA Inside Siebel Clinical
  27. 27. BioPharm Services for Integration andAnalytics• 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. 28. Agenda• Oracle Clinical Development Analytics• Working with CDA and Clinical Operations andClinical Data Management• Creating new reports and dashboards• CDA Architecture• Extending CDA• Questions and Answers
  29. 29. Contact InformationIf you have additional questions please contact:United States: +1 877 654 0033United Kingdom: +44 (0) 1865 910200Email Address: info@biopharm.comWebsite: www.biopharm.com

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