Data Warehouse Implementation

September, 2013
Mike Grossman
Vice President of Clinical Data Warehousing and Analytics BioPharm Systems

Oracle Health Sciences User group September 2013

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Welcome & Introductions

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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Agenda
Example types of Data Warehouses Why use LSH Techniques for creating Data Warehouses Challenges

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Example Types of Data Warehouses

Oracle Life Sciences Data Hub (LSH) can be used to prepare data for reporting, analysis, medical review, and data mining. One of the more complex tasks for successful cross-study reporting, analysis, medical review, and data mining systems is implementing a warehouse that will withstand the test of time. Types of warehouses:
Operational data for clinical operations and data management Exploratory analysis and predictive analytics Medical review Safety mining
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Operational Metrics Data Warehouse

Oracle Clinical Development Analytics (CDA) Dimensional Models proven Integration of CTMS, EDC, Project management, and financial systems Is this part of corporate enterprise warehouse strategy? Match merge of key entities Does it need formal validation and audit?

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Exploratory Analysis and Predictive Analytics

(Acquire, Transform, Enhance, Standardize) AE Study Data

Stage 1. Data Preparation

(Acquire, Transform, Enhance, Standardize)

Stage 2. Select & Explore

DM

EDC data and other study data

Ad hoc & Selection Components Std Analysis

Value Added Processing

Data Standardization

Outcomes

Stage 3. Analytics & Model Building

Analyze, Define and Train Model

Historic Dataset Files

Stage 4. Deployment & Reuse

Selection Components

Predictive Analysis Components

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Oracle Health Sciences User group September 2013

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Medical Review Data Warehouse

Sourced from EDC and other clinical trial data Automatically pooled study data Dimensional model for cross-study review Specialized data marts for patient profile Write back functionality for review status tracking Graphical review tool, typically Spotfire or Jreview Some sort of auditing is required to indicate What has changed since I last reviewed this subject ?

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Safety Mining Warehouse

Many Sources including
Safety System such as Argus FDA AERS database Clinical Trial data Healthcare records

Specific data marts needed for structured mining and signal management
Empirica Signal and Empirica Topics

Broad data model for exploratory mining

Oracle Health Sciences Translational Research Center Oracle Healthcare Data Warehouse Foundation
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Why Use LSH?

Version control, snapshots, and Auditing Multiple environments in a single application
Development, Test, Production

Security Data Blinding/Unblinding Life Cycle Management Reusability LSH APIS can automate complex tasks such as
Automatically adding studies to dimensional models Automatically generate longitudinal data marts from subject subsets
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Techniques for creating a Warehouse

Within LSH
Using Programs to pool, Conform, aggregate data Use generated pooling/conformation tools

External to LSH
Using data sourced from LSH and/or external sources Using Informatica external, store data mart in LSH Using PLSQL

Common tools
Data loads Pass-through views No coding using reusable components Automatic creation of target structures from source Familiar use of Oracle tables and views, SAS datasets, Text files Automated batch loads (scheduled or triggered by message)

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Example Data Warehouse Build Processes (show a few)

Conform data from multiple sources to a single format

Pool
Merge the data from multiple sources into a single structure format Evaluate data for audit, if audit is unavailable

Base Facts
Establish facts from pooled data using Audit data to establish SCD

Aggregate base facts to higher levels of aggregation

Conform

Audit

Aggregate

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Challenges in Warehousing Implementation

Auditing may not be available Appropriate expertise may not be available Multiple version of Standards/changing standards
For source data For target data mart

Big single corporate enterprise warehouse balances with special purpose warehouses Tracking the process around data review and signal management
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Q&A

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Contact Us
North America Sales Contacts: Rod Roderick, VP of Sales, Trial Management Solutions rroderick@biopharm.com +1 877 654 0033

Vicky Green, VP of Sales, Data Management Solutions vgreen@biopharm.com +1 877 654 0033

Europe/Middle East/Africa Sales Contact: Rudolf Coetzee, Director of Business Development rcoetzee@biopharm.com +44 (0) 1865 910200 General Inquiries: info@biopharm.com
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