Enriching the Value of Clinical Data with

Oracle Data Management Workbench

August 2017

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About Perficient

Perficient is the leading digital transformation

consulting firm serving Global 2000 and enterprise

customers throughout North America.

With unparalleled information technology, management consulting,

and creative capabilities, Perficient and its Perficient Digital agency

deliver vision, execution, and value with outstanding digital

experience, business optimization, and industry solutions.

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Perficient ProfileFounded in 1997

Public, NASDAQ: PRFT

2016 revenue $487 million

Major market locations:Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chicago,

Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,

Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,

New York City, Northern California, Oxford (UK), Southern

California, St. Louis, Toronto

Global delivery centers in China and India

~3,000 colleagues

Dedicated solution practices

~95% repeat business rate

Alliance partnerships with major technology vendors

Multiple vendor/industry technology and growth awards

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Prabha Ranganathan

Director, Clinical Data Warehousing and

Analytics, Perficient

Today’s Presenters

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Srinivas Karri

Director of Product Strategy, Oracle

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• Oracle Data Management Workbench Overview

• Data Management Use Cases

• Next Steps

• Q&A

Agenda

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Clinical Data ManagementMore than Electronic Data Capture

Copyright © 2017, Oracle and/or its affiliates. All rights reserved. |

Safe Harbor Statement

The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

8srinivas.karri@oracle.com

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Laboratory Data

ePro Data

mHealth/IoT

InForm EDC Bi-directional query resolution Aggregate Clean Transform

Clinical & Operational Analytics

Medical Review

Study DataTabulationModel Datasets

Oracle Data Management Workbench

Cloud Platform Service

srinivas.karri@oracle.com

EMR/EHR

End-to-End Data

Management

• Single platform for data

cleaning, reconciliation,

and transformations

across multiple source

systems

• Seamless integration

with InForm, TMS, and

external data sources

Accelerate Trial Timelines

• Automation workflow

reduces time from raw

data collection to data

ready for Biostatistics

• Re-usable template

library of data models,

transformations, and

validation checks

Improve Compliance

• Secure data access,

blinding & masking,

version control, and data

lineage traceability

• Faster access to clean

data for more interim

analyses

Biostats

Data Models

ACQUIRE ANALYSIS

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Data Models

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Manage Discrepancies

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Validation Checks

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Exporting, Reporting, Visualizing Data

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Study Setup - Reusability

DMW Approach

• Study Templates

• Library Data Models

• Copy Functionality

Data Models and Tables

Transformations

Validation Checks

Custom Listings

Business Use Case

• Standard setup at a Study

Grouping Level

• Multiple Standards

• Reuse Setup from One Standard

definition

Oncology Template

Study 87123 Study 83456 Study 57432 Study 87523

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Data Review and Cleaning

DMW Approach

• Flags and States

• Record level

• Subject visit level

• Transformations

• Filters

• Discrepancy Workflow

• Customized workflow

• Actions and tags

Business Use Case

• Review Data

• Familiar metadata across all studies

• Mark data issues for review and

data correction

• Mark reviewed data

• Set subject visit status

• Set data status

• Ability to review new/changed data

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Study – Review Progress Tracking

DMW Approach

• Flags and States

• Subject Visit

• Record

• Custom Programs

• Transformations

• Validation Checks

• Filters

Business Use Case

• What is clean

• What needs to be reviewed?

• Whose review is needed?

• Status of updates from external

sources

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Study – Milestone Readiness

DMW Approach

• Flags and States

• Transformations and VCs

• Study performance based on

historic data from similar studies

• Discrepancy workflow

• DataSources

Business Use Case

• Status of study

• Ready for a milestone

• Interim submission

• Study lock

• What is pending

• How long will it take to complete

the tasks to reach a milestone

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Where to Go from Here

Next steps

• For those not quite ready yet

– Collaborate on requirements

• For those interested in seeing more of DMW

– Schedule a demo

• Looking to harmonize your business processes?

– Schedule a call to discuss your situation

Competitive advantages & capabilities

• Architectural, technical, and best-practice guidance

for the implementation of DMW

• Gap assessments

• Development of utilities

• Extensive experience implementing and integrating

clinical and PV applications

• Expertise in project management and process

re-engineering

• Technology evaluation and implementation to

support the strategy

• Health checks

• Roadmap development

• 18+ years of helping organizations select, configure,

implement, integrate, and manage Oracle Health

Sciences applications

Questions?

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• “Improving the Clinical Data Review Process with

Oracle Data Management Workbench” | Download

• “How to Review, Cleanse, and Transform Clinical

Data in Oracle InForm” | View On Demand

• “How to Load Data More Quickly and Accurately into

Oracle's Life Sciences Data Hub” | View On Demand

Additional Resources• Perficient.com/SocialMedia

• Facebook.com/Perficient

• Twitter.com/Perficient_LS

• Blogs.perficient.com/LifeSciences