This presentation discusses the practical considerations of implementing and customizing Oracle Clinical Development Analytics (OCDA). It provides an overview of OCDA and its architecture, shows some example star schemas, and discusses challenges such as handling multiple Oracle Clinical instances, integrating additional data sources, and preserving customizations across releases.

1. Practical Considerations of
OCDA I Implementation and
l t ti d
Customization
November 6th, 2012
Mike Grossman
VP, Clinical Data Warehousing
and Analytics
BioPharm Systems
Oracle Health Sciences User group November 2012 PREVIOUS
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2. Agenda
• Oracle Clinical Development Analytics (OCDA)
• OCDA Architecture
A hit t
• Example Star Schemas
• OCDA Implementation Challenges
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3. Agenda
• Oracle Clinical Development Analytics (OCDA)
• OCDA Architecture
A hit t
• Example Star Schemas
• OCDA Implementation Challenges
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4. Oracle Clinical Development Analytics (OCDA)
• OCDA is an extensible warehouse and reporting solution
that supports Clinical Operations and Clinical Data
Management
• OCDA combines data from CTMS and EDC/CDMS
• OCDA includes pre-packaged interactive dashboards and
reports
• OCDA i l d a d t warehouse optimized f
includes data h ti i d for
understanding the running of trials
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5. Agenda
• Oracle Clinical Development Analytics (OCDA)
• OCDA Architecture
A hit t
• Example Star Schemas
• OCDA Implementation Challenges
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6. OCDA Architecture
Oracle BI Enterprise Edition Plus
Duration of Open Discrepancies
MS Office iPhone
Interactive Dashboards Proactive Alerts
Ad‐hoc Analysis Integration Integration
Integrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMS
CDA Informatica CDA Informatica
SDE ETL SIL ETL CDA Clinical Warehouse
CDA Staging Tables
Schemas
Oracle Clinical Seibel Clinical
Note: SDE (Source Dependant Extract) / SIL (Source Independent Load)
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7. Agenda
• Oracle Clinical Development Analytics (OCDA)
• OCDA Architecture
A hit t
• Example Star Schemas
• OCDA Implementation Challenges
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8. Example Star Schemas
Product
Study
g p y
Geography
•Study Team
Case Discrepancy
p y
Report
Report Site
Form Fact
Study‐Site
y
Party •Study‐Site
Team
Study
Subject
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9. Example Star Schemas
Product
Day Program
Geography
Study Site Study
Status Fact •Study Team
Study Site
Study
•Study Site Region
Team
Site
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10. Example Star Schemas
Product
Product
Day
Case
Report
R
Form
Study
Study
•Study Team
•Study Team
Study Site Program
Discrepancy
Party Fact Status Fact
Geography
Geography
Study
Study Region
Subject Study Site
Study‐Site
y y Site
Site
•Study Site
•Study‐Site
Team
Team
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11. Agenda
• Oracle Clinical Development Analytics (OCDA)
• OCDA Architecture
A hit t
• Example Star Schemas
• OCDA Implementation Challenges
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12. OCDA Implementation Challenges
• Multiple OC Instances
• S
Sources other than/in addition to OC and SC
th th /i dditi t d
• Preserving customizations across OCDA releases
– Various customizations to vanilla SC product
– Additional Operating Metrics not supported out-of-the-box by OCDA
• Duplicate Study, Site, Subject, etc data in OC and SC
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13. OCDA Implementation Challenges - Adding a new OC Source Instance
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14. OCDA Implementation Challenges - Adding a new OC Source Instance-Notes
• No new programming, only LSH configuration to define
new staging area for the new OC instance
• SDE logic same as shipped by Oracle
• Use of LSH View Object to pool data from the 2 OC
instances
• Assumption: no common study or other data among the
various sources
i
• Note: Control Table Logic needs to be modified to make
sure the additional pooling step does not break the
incremental load logic
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15. OCDA Implementation Challenges - Adding a new Source (RAVE)
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16. OCDA Implementation Challenges - Adding a new Source (RAVE)
• Each source entity must be conformed to the source
independent structure
• Very careful design and development needed for defining
new SDE’s for RAVE and conforming them to the structure
that OCDA Pooling area expects
• High effort
• A
Assumption: no common study or other d t among th
ti t d th data the
various sources
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17. OCDA Implementation Challenges – Preserving Customizations on Upgrade
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18. OCDA Implementation Challenges – Preserving Customizations on Upgrade
Advantages
• Clean separation of Oracle shipped OCDA code from
customized code
• All ETL and Table Instances point to the original Oracle shipped
definitions unless customized
• Central control table controlling incremental load for the entire
OCDA installation
• Upgrades are safe and clean: all Oracle-shipped upgrades are
applied t OCDA d
li d to OCDA_domain, th not impacting any production
i thus t i ti d ti
code. Automation can help compare differences between
Oracle-shipped code and Production code making the decision
to selectively accept the upgrades easier
y p pg
• Note: Control Table logic needs to be changed slightly to visually identify the various programs from different
domains and selectively wipe out incremental load data when doing a full load for a domain
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19. Merging OC and SC Dimensions
• OCDA has match-merge capability built in
– Winner Donor mapping table
Winner-Donor
– Winner-Donor may be populated with Oracle Healthcare Master
Person Index (OHMPI)
– Di
Dimension SILs populate winner i f
i SIL l t i information i Di
ti in Dimension records
i d
based on the input from mapping table
• Determine and design how to populate the mapping table
based on customer interviews
• Implement logic in the ETL flow to populate mapping table
before Dimension SIL runs
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20. Merging OC and SC Dimensions – Case Study from Actual Customer
Implementation
• Requirement to match and merge SC and OC Studies and
Study-Sites
y
• SC has been customized so that
– SC Protocol table holds either the matching OC Study name or Study
ID
– SC Site table holds either the matching OC Study-Site ID or Study-Site
code
– Users can manually override this mapping in a separate table
• Merge Program runs after the Study and Study-Site Pooling
Step and populates the mapping table with winner-donor
information
• Out-of-the-box OCDA SIL logic takes care of the rest
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21. Biography and Contact Us
• Michael Grossman, BioPharm Systems' vice president of clinical data warehousing and
analytics, is responsible for the design and implementation of clinical data warehousing
and analytics applications. Prior to joining the company, he was senior director of health
sciences strategy at Oracle for 10 years. One of his key accomplishments at Oracle was
the initiation and development of Oracle Life Sciences Data Hub. Michael's career began
at Hoffmann-La Roche, where he served as global head of clinical programming.
• North America S l C t t
N th A i Sales Contact:
Rod Roderick
rroderick@biopharm.com
+1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
Rudolf Coetzee
rcoetzee@biopharm.com
+44 (0) 1865 910200
( )
• General Inquiries:
info@biopharm.com
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