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

6. CDA Pre-Built Reports

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