How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

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When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster. During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.

Technology

How to Review, Cleanse,
and Transform Clinical Data
in Oracle InForm
December 2016

2
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.

Prabha Ranganathan
Director, Clinical Data Warehousing
and Analytics
• 15+ Years in Life Sciences
• 20+ Years in IT
• MS in Computer Science
• MBA

5
• Clinical Data Review Process
• DMW Demo For Data Review
• Flags and States
• Filters
• Transformations
• Discrepancy Workflow
Agenda

6
• 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

7
• 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

8
• 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

9
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

Questions
Type your question into the chat box

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How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

1. How to Review, Cleanse, and Transform Clinical Data in Oracle InForm December 2016

2. 2 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.

3. 3 Perficient Profile Founded 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

4. Prabha Ranganathan Director, Clinical Data Warehousing and Analytics • 15+ Years in Life Sciences • 20+ Years in IT • MS in Computer Science • MBA

5. 5 • Clinical Data Review Process • DMW Demo For Data Review • Flags and States • Filters • Transformations • Discrepancy Workflow Agenda

6. 6 • 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

7. 7 • 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

8. 8 • 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

9. 9 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

10. 10 Data Management Workbench Demo

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26. Questions Type your question into the chat box

27. 27 • Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance | Register January 12, 2017 • Cultivating Pharma-Patient Relationships in the Digital Era | Register January 26, 2017 Follow Us Online • Perficient.com/SocialMedia • Facebook.com/Perficient • Twitter.com/Perficient_LS • Blogs.perficient.com/LifeSciences

28. Thank You

How to Review, Cleanse, and Transform Clinical Data in Oracle InForm

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