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Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources

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Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources

  1. 1. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 1 Using DMW to Optimize the Management of Clinical Data from InForm and Other Sources January 30, 2014 Mike Grossman VP, Clinical Data Warehousing & Analytics BioPharm Systems
  2. 2. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 2 Welcome & Introductions Mike Grossman VP of Clinical Data Warehousing and Analytics BioPharm Systems • 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 Oracle’s Life Sciences Data Hub (LSH) and other data warehousing and analytics solutions • Extensive LSH experience – 10 years of experience designing and developing LSH at Oracle – 27 years in the industry – 5+ years of experiencing implementing LSH at client sites
  3. 3. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 3 Agenda • Overview – Industry challenges – Drivers and goals • Setting up studies – Setting up a study – Creating data models – Transforming data – Creating validation checks • Managing study data – Reviewing data – Creating discrepancies – Managing discrepancies – Exporting data • Conclusions and Q&A
  4. 4. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 4 Overview – Industry Challenges • Complex data validation – Without burdening the data capture process • Data cleaning and reconciliation – Inconsistencies across data from multiple sources – How to raise discrepancies and where to send them • Medical review to flag inconsistencies in the data • Data transformation and standardization – Separate sources must be conformed, aggregated, and compared – Maintain data lineage
  5. 5. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 5 Overview – Drivers • Increased productivity and efficiency by – Reducing manual processing – Promoting reusability with templates of standard objects and rules • Increased outsourcing and collaboration, both internal and external • Need for connected processes – Changing regulatory environment – Separate and complex data sources
  6. 6. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 6 Overview – Goals • Single version of truth for cleaning, transformation, and analysis • Open architecture to support the right visualization and analysis tools for the job • Scalable, to support large data volumes • Extensible, to integrate with enterprise applications and architecture
  7. 7. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 7 DMW Overview
  8. 8. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 8 Setting Up a Study • A study includes – One or more clinical data models – Mappings and transformation programs, to read data from one clinical model and write it to the next model – Edit check programs, to validate the data in a clinical data model and raise discrepancies – Custom listings, created to aid the review of clinical data
  9. 9. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 9 Setting Up a Study
  10. 10. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 10 Creating Data Models
  11. 11. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 11 Creating Data Models – Adding Central Lab Data
  12. 12. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 12 Creating Data Models – Adding InForm Data
  13. 13. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 13 Transforming Data • Clinical data may have – Many sources – Many formats • For reviewing data, design a review model that lets data managers and other downstream users access all data • Transform the data by mapping multiple sources to the single review model • Perform additional transformations, as required, for other users
  14. 14. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 14 Transforming Data InForm Views Central Lab 1 Central Lab 2 Source Format Data Models Review Format Data Model Analysis Data Model SDTM Export
  15. 15. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 15 Transforming Data
  16. 16. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 16 Creating Validation Checks
  17. 17. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 17 Reviewing Data • Some features that support efficient data review include – Using searches and filtering the data – Using custom listings – Showing data flags (custom and InForm) – Showing and navigating to discrepancies – Tracing data lineage – Exporting the data to an Excel or CSV file
  18. 18. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 18 Reviewing Data – Custom Listings • Add columns from one or more sources • Reorder and sort the columns • Add selection criteria • Review the results • Save the custom listing
  19. 19. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 19 Reviewing Data – InForm
  20. 20. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 20 Creating Discrepancies • Select one or more records on which to create a discrepancy • Add the text message • Choose a category and state • Save the new discrepancy
  21. 21. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 21 Managing Discrepancies • From the discrepancies listings you can – Filter the data – Set the discrepancy state (Close Discrepancy, Needs DM Review, etc.) – Take action, such as adding a comment, on one or more discrepancies
  22. 22. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 22 Managing Discrepancies You can review • The details of each discrepancy • Its full InForm record • Its complete history
  23. 23. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 23 Exporting Data • Export to Excel – Data from any model – Discrepancies • Export to CSV – Sort and filter the data – All displayed records are included in the export
  24. 24. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 24 Exporting to Excel
  25. 25. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 25 Exporting Lab Data to CSV
  26. 26. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 26 Q&A
  27. 27. PREVIOUS NEXTPREVIOUS NEXT Using Oracle Health Sciences Data Management Workbench to Optimize the Management of Clinical Data from InForm and Other Sources, January 2014 Slide 27 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) 7810 373045 • General Inquiries: – info@biopharm.com

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