plug & play: benefits of out-of-the-box clinical development analytics (cda) for siebel clinical

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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