2013 ohsug - benefits of out-of-the-box-cda for siebel clinical
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Benefits of Out-of-the-Box-CDA for Siebel ClinicalTRANSCRIPT
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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
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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
[email protected] | (210) 454-5192
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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
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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
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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.
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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
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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.
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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.
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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
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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
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Slide 11
CDA and Siebel Clinical
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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
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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.)
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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?
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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
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Slide 16
Live Demo – CDA and Siebel Clinical
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Slide 17
Q&A
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Slide 18
Closing
Thank you for attending!
www.biopharm.com
+1 877-654-0033
+44 (0) 1865 910200
18
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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
[email protected] | (210) 454-5192
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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