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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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

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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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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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What is Clinical Development Analytics?

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.

This slide courtesy Oracle

Copyright 2012, Oracle and/or its affiliates. All rights reserved.

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What is Clinical Development Analytics?

CDA Presentation Engine & Role-based Dashboards

Clinical Development Users from Executives to Sites

CDA Warehouse & Analysis Engine

View progress at the organizational, regional, study or site level

Such as OC / RDC, Siebel Clinical, and third party systems

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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CDA and Siebel Clinical

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Benefits of Using CDA with Siebel Clinical

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

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Benefits of Using CDA with Siebel Clinical (cont.)

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

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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 organizations unique requirements
Pick data points Look at results and Save Add Graphical Displays

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Live Demo CDA and Siebel Clinical

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Q&A

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Closing Thank you for attending!

www.biopharm.com

psingh@biopharm.com mgrossman@biopharm.com +1 877-654-0033 +44 (0) 1865 910200

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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 Oracles 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
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psingh@biopharm.com | (210) 454-5192

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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 Oracles 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
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