How to Review, Cleanse,

and Transform Clinical Data

in Oracle InFormDecember 2016

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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

2015 revenue $473.6 million

Major market locations:

Allentown, Atlanta, Ann Arbor, Boston, Charlotte,

Chattanooga, 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

Prabha RanganathanDirector, Clinical Data Warehousing

and Analytics

• 15+ Years in Life Sciences

• 20+ Years in IT

• MS in Computer Science

• MBA

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• Clinical Data Review Process

• DMW Demo For Data Review

• Flags and States

• Filters

• Transformations

• Discrepancy Workflow

Agenda

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• Roles and responsibilities

• Visualizations

• Data checks

• Standard data structures

• Comments and workflow

Overview of Data Review

Process

Clean Data for Reporting and Submission

Safety and Efficacy Review

Medical Monitor Review

Data Manager Review

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• Auditing and tracking

• Who reviewed data?

• When was data reviewed?

• What was reviewed?

• What is yet to be reviewed?

• Is review complete?

• Is data ready for milestone?

• New and change data

Challenges with Data

Review Process

Clean Data for Reporting and Submission

Safety and Efficacy Review

Medical Monitor Review

Data Manager Review

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• Format of review

• Trends

• Listings

• Prioritization of review

• Time sensitivity

• Combining data with other sources

• Planning and predicting review effort

Challenges with Data

Review Process

Clean Data for Reporting and Submission

Safety and Efficacy Review

Medical Monitor Review

Data Manager Review

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Data Management Workbench

InForm

Lab

Central

Labs

ReviewTransform

• Combine data from multiple sources

• Transform data to standard data structures

• Filter data

• Flags and states

• Comments and discrepancy workflow

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Data Management Workbench Demo

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QuestionsType your question into the chat box

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Follow Us Online

• Perficient.com/SocialMedia

• Facebook.com/Perficient

• Twitter.com/Perficient_LS

• Blogs.perficient.com/LifeSciences

Thank You