Benefits of Out-of-the-Box-CDA for Siebel Clinical

1. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 1
Benefits of Out-of-the-Box CDA
for Siebel Clinical
[Session #]
[Date]
Parambir Singh
Vice President,
Clinical Trial Management Solutions
BioPharm Systems
Mike Grossman
Vice President,
Clinical Data Warehousing and Analytics
BioPharm Systems

2. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 2
Welcome & Introductions
Param Singh
Vice President, Clinical Trial Management Solutions
BioPharm Systems, Inc.
Mike Grossman
Vice President of
Clinical Data Warehousing and Analytics
psingh@biopharm.com | (210) 454-5192

3. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 3
Agenda
• Industry Trends and Challenges
• What is CDA?
• CDA Out-of-the-Box
• What are the benefits of using CDA
and SC together?
• Custom Reporting
• Live Demo
• Q&A

4. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 4
Industry Trends
• Significant Increase in Outsourcing of Trials
– Moving from one-off interactions to
partnership-based relationships
• Clinical trials are becoming increasingly complex
– More trials, more regulations, more regions, more resources
• Accurate forecasting and real time reporting
is more important than ever
– Need the ability to view and report on data in
different ways

5. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 5
Industry Trends
• Need to address cost pressures and proactively reduce
patient risks on increasingly complex clinical trials.
• Companies are moving to a more efficient and holistic
approach to decision support to get more value from data
collected
• This new approach reduces overall costs and makes data
available from numerous sources.
• As a result, organizations are able to make important
decisions faster based on more accurate data.

6. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 6
Reporting Challenges with Siebel Clinical
• Limited number of out-of-the-box reports
– Provides basic information in specific areas only
– Little flexibility for end user in data displayed
• Export capability nice, but requires additional manipulation
– Basic data dump
– Requires knowledgeable resource to display in logical or
graphic fashion
• New reports must be developed using BI Publisher or other
reporting tool
– May be time consuming, depending on the tool
– Requires design, development, validation and testing
– Requires experienced development resource

7. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 7
Oracle Health Sciences Clinical Development Analytics is a comprehensive
analytics solution that provides sponsors and CROs timely, fact-based insight
into clinical programs to make more informed business decisions, increase
R&D productivity, and develop drugs more effectively.
What is Clinical Development Analytics?
This slide courtesy Oracle
Copyright © 2012, Oracle and/or its affiliates. All rights reserved.

8. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 8
CDA Warehouse &
Analysis Engine
What is Clinical Development Analytics?
CDA Presentation
Engine &
Role-based
Dashboards
Such as OC / RDC, Siebel Clinical, and third party systems
Clinical Development
Users from Executives
to Sites
View progress at the
organizational,
regional, study or site
level
This slide courtesy Oracle
Copyright © 2012, Oracle and/or its affiliates. All rights reserved.

9. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 9
CDA – Out-of-the-Box Content
Contains over 150 pre-built reports and dashboards
• Trial Management
24 pre-packaged reports
–Covering Screening and Recruitment, Retention and Document
Management
–Primary Data Source is Siebel Clinical
• Data Management
26 pre-packaged reports
–Covering both EDC and Paper processes
–Primary Data Source is Oracle Clinical / Oracle Remote Data
Capture

10. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 10
CDA – Out-of-the-Box Content (cont.)
• Data warehouse optimized for clinical trials
– Contains over 1,000 business attributes
– Attributes cover performance management metrics and
associated descriptive terms about clinical trial progress
# Subjects Enrolled, Study Name, Site, # eCRFs Approved, etc…
• Pre-built business adapters for Clinical Applications

11. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 11
CDA and Siebel Clinical

12. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 12
• Helps sponsors and CROs make more informed
business decisions
– Review and manage all clinical programs across the
organization to make key business decisions early
• Provides instant access to study and project status
metrics
– Accelerates study progress with better visibility into data
– More easily track Study, Region and Site Progress
– Identify non-performing sites and better focus resources
Benefits of Using CDA with Siebel Clinical

13. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 13
• Improves Clinical Productivity and Effectiveness
– Increase effectiveness via more focused resource optimization
– Reduce costs via greater site visibility, minimizing unnecessary
travel expenses
– Improve overall study performance by identifying non-performing
sites earlier
– Manage site performance and focus resources on most critical
sites
Benefits of Using CDA with Siebel Clinical (cont.)

14. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 14
Additional Benefits for Study Team Members
• Clinical Monitor
– How is enrollment progressing?
– What are the most common reasons for screen failure?
• Study Manager
– Which documents are outstanding, preventing site readiness?
– Which sites are taking the longest to return documents?
– Which sites are the best and worst performers?
• Program Manager
– Which regions are recruiting the most sites?

15. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 15
Custom Reporting
• Reports and dashboards can be quickly customized and
extended to meet an organization’s unique requirements
– Pick data points
– Look at results and Save
– Add Graphical Displays

16. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 16
Live Demo – CDA and Siebel Clinical

17. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 17
Q&A

18. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 18
Closing
Thank you for attending!
www.biopharm.com
psingh@biopharm.com
mgrossman@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200
18

19. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 19
Presenter Bio
Param Singh
Vice President, Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice lead since 2007
– Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, enhances, and
integrates Oracle’s Siebel Clinical solution
• Extensive Siebel Clinical implementation experience
– 12+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel Clinical
psingh@biopharm.com | (210) 454-5192

20. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 20
Presenter Bio
Mike Grossman
Vice President of
Clinical Data Warehousing and Analytics
BioPharm Systems, Inc.
• CDW/CDA practice lead since 2010
– Expertise in managing data for all phases and styles of clinical trials
– Leads the team that implements, supports, enhances, and integrates
Oracle’s LSH and other data warehousing and analytic solutions
• Extensive Oracle Life Sciences Hub (LSH) experience
– 10 years of experience designing and developing Oracle Life Sciences
Hub at Oracle
– 27 years in the industry
– 5+ years of experiencing implementing LSH at client sites