Leveraging Oracle's Clinical Development Analytics to Boost Productivity and Reduce Costs

Copyright BioPharm Systems, Inc. 2009. All rights reserved

Leveraging

Oracle's Clinical

Development Analytics

to Boost Productivity

and Reduce Costs

Mike Grossman VP Clinical Warehousing and

Analytics

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and Answers

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and answers

Clinical Development Analytics

• Clinical Development Analytics (CDA) is an

extensible warehouse and reporting solution that

supports Clinical Operations and Clinical Data

Management

• CDA combines data from CTMS and EDC/CDMS

• CDA incudes pre-packaged interactive

dashboards and reports

• CDA includes a data warehouse optimized for

understanding the running of trials

CDA Pre-Built Content

• Clinical Data Management

– Covering both EDC and Paper processes

• 26 pre-packaged reports

– Primary Data Source

• Oracle Clinical / Oracle Remote Data Capture

• Clinical Operations

– Covering Screening and Recruitment, Retention and Document

Management

• 24 pre-packaged reports

– Primary Data Source

• Siebel Clinical

• 369 pre-built measures & attributes

– Operational metrics such as # eCRFs Approved, # Subjects Enrolled

– Supporting attributes such as Study Name, Site Name

CDA Pre-Built Reports

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and answers

Study Site Start Up - Overview

Study Site Start Up – What’s In Place Before Site Start Up?

Study Site Enrollment – How is Enrollment Going?

Study Enrollment -Too Many Screen Failures?

What’s the Status of eCRF Entry and Approval?

Is My Data Clean?

What’s Going on With Early Terminations?

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and answers

How Do I Create A New Report?

Pick Your Data Points

Look at the Results and Save

Add Some Graphical Displays

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and answers

CDA’s Pre-Built Clinical Warehouse

Ad-hoc Analysis Interactive Dashboards Proactive Alerts MS Office Integration

Oracle BI Enterprise Edition Plus

Integrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMS CDA Informatica

SIL ETL CDA Clinical Warehouse

Schemas CDA Staging Tables

Oracle Clinical Seibel Clinical

CDA Informatica

SDE ETL

Duration of Open Discrepancies

iPhone Integration

Note: SDE (Source Dependant Extract) / SIL (Source Independent Load)

This Slide is from Oracle Corp.

Holistic Reference, Clinical IT Reference Architecture

Outcomes

Common Data

Model

Project level

Conformed Data

Value Added

Study Data

Conformed Study

Data

Operational Trial

Metrics

Inbound

Data

Sources

Master Meta Data

AES & Complaints

Outcomes

External Study

Data

LIMS/PK

Central Labs

CDMS/ EDC

CTMS

Staging

Area

AES & Complaints

Source Specific

Outcomes Data

Shared Study and

Project Meta

Data

Study Specific

Data Staging

Trials

Management

Warehouse

Area

Specialized Data

Marts for

Scientific

Exploration and

Mining

Specialized Data

Marts for

Scientific

Exploration and

Mining

Specialized Data

Marts for

Scientific

Exploration and

Mining

Patient Sub

Setting and

Safety

Warehouse

Clinops Data

Marts

Meta Data Libraries, Version Control, Compliance Change Mgt

Ad-Hoc Query Dashboards Structured Reports Analytical Tools

Strategic

Analysis

Regulatory

Reporting

Data Mining

Clinical

Developmen

t Planning

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and Answers

OCDA Speed Time to Value and Lower Total Cost of Ownership Compared with Traditional Tools

Pre-built Data Warehouse design, adapts to enterprise data

Build from Scratch with Traditional Tools

Oracle Analytics Applications

Months

Back-end

ETL and

Mapping

Data Warehouse Design

Define Metrics

& Dashboards

Back-end ETL and Mapping

Data Warehouse Design

Define Metrics & Dashboards

Training/Roll-out

Training/Rollout

Quarters or Years

Sources: Patricia Seybold Research, Gartner, Merrill Lynch, Oracle Analysis

Pre-built business adapters for Clinical Applications

Role-based dashboards and hundreds of pre-defined metrics

Easy to use, easy to adapt

• Faster deployment

• Lower TCO

• Assured business value

This Slide is from Oracle Corp.

How Can CDA Be Extended?

• Add to dimensions and facts, attributes, and measures

• Use only Oracle Clinical or Siebel Clinical

• Supplement with data from other systems and warehouses

such as Oracle BAW or SAP

• Supplement with external data (CRO, Sponsor, Partner)

• Combine with other clinical content, such as subject data

• Replace a source system with one or more solutions. For

example, home grown CTMS for SC or Inform for OC

• Supplement OBIEE with other reporting tools such as

Spotfire

CDA Inside Siebel Clinical

BioPharm Services for Integration and Analytics

• Business case development and cost analysis

• Requirements and design management

• Best practice analysis and recommendations

• Installation and configuration

• Oracle CDA and LSH pilots and proofs of concept

• Hosting

• Oracle CDA and LSH implementation

• CDA and LSH validation

• CDA and LSH training

• CDA and LSH extension development

Agenda

• Oracle Clinical Development Analytics

• Working with CDA and Clinical Operations and

Clinical Data Management

• Creating new reports and dashboards

• CDA Architecture

• Extending CDA

• Questions and Answers

Contact Information

If you have additional questions please contact:

United States: +1 877 654 0033

United Kingdom: +44 (0) 1865 910200

Email Address: info@biopharm.com

Website: www.biopharm.com