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Plug and Play: Benefits of Out-
of-the-Box CDA for Siebel
Clinical
Parambir Singh
Vice President,
Clinical Trial Management Solutions
BioPharm Systems
Rohit Sharma
Principal Consultant
Clinical Data Warehousing and Analytics
BioPharm Systems

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Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice head 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
– 11+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel Clinical

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Welcome & Introductions (cont.)
Rohit Sharma
Principal Consultant in CDW&A practice
BioPharm Systems, Inc.
• 16 years of industry experience
– Understanding and developing clients' business process and data
warehousing needs
– Architecting a technical solution that can fit seamlessly into their IT
landscape
• Extensive Oracle LSH and CDA experience
– Worked at Oracle as the development manager for Oracle's Life
Sciences Data Hub (LSH) and Clinical Development Analytics (CDA)
– Multiple implementations and integrations of CDA/LSH

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Welcome & Introductions (cont.)
CTMS / CDW&A Practice Services
Implementations
Manage implementations of Siebel
Clinical, ClearTrial, LabPas, LSH, CDA,
and various accelerators.
Integrations
Build one- and two-way interfaces
between Siebel CTMS, LSH, CDA, and
other clinical and non-clinical systems.
Training
Develop and/or deliver standard and
custom training classes and materials.
Process Guidance
Provide insight, advice, and solutions
to specific clinical trial management,
data, warehousing, and analytics
issues.

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Agenda
• Industry Trends and Challenges
• What is CDA?
• CDA Out-of-the-Box Demo
• What are the benefits of using CDA
and SC together?
• CDA with Siebel CTMS Demo
• How can BioPharm Help
• Q&A

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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

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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

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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

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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.

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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.

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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

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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

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Live Demo – Clinical Development Analytics

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CDA and Siebel Clinical

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• 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
– Easily track Study, Region, and Site Progress
– Identify non-performing sites and better focus resources
Benefits of Using CDA with Siebel Clinical

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• 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.)

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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?

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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

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Live Demo – CDA within Siebel Clinical

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How BioPharm Can Help
• Services
– Demonstrations
– Analysis Workshops
– Business case development and cost analysis
– Requirements and design management
– Best practice analysis and recommendations
– Installation and configuration
– Pilots and proofs of concept
– Hosting
– Implementation
– Validation
– Training
– Extension development projects
• Products
– Access to or installation of a CDA sandbox environment
– ASCEND implementation with CDA

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Q&A

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Closing
Thank you for attending!
www.biopharm.com
info@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200