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

50 %
50 %
Information about Using Oracle Health Sciences Data Management Workbench to Optimize the...
Technology

Published on March 10, 2014

Author: BioPharmSystems

Source: slideshare.net

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Add a comment

Related presentations

Related pages

Using Oracle's Data Management Workbench (DMW) with InForm ...

Learn how Oracle Health Sciences Data Management Workbench (DMW) can be used to optimize the management of clinical data from InForm and other ...
Read more

data management workbench | Resources: Clinical Trial ...

Tag Archives: data management workbench USING ORACLE DATA MANAGEMENT WORKBENCH TO OPTIMIZE THE MANAGEMENT OF CLINICAL DATA FROM INFORM AND OTHER SOURCES ...
Read more

Health Sciences - Biopharma/Medical Device Software | Oracle

... rely on Oracle Health Sciences Cloud to optimize ... and medical device companies are using cloud ... Health Sciences Data Management Workbench.
Read more

Oracle Introduces Oracle Health Sciences Data Management ...

Oracle Introduces Oracle Health Sciences Data Management Workbench to Aggregate, Reconcile and Transform Disparate Sources of Clinical Trial Data
Read more

Oracle Health Sciences Data Management Workbench User’s Guide

Oracle® Health Sciences Data Management Workbench User's Guide ... Integration with Oracle Health Sciences InForm ... Library Clinical Data Models ...
Read more

Oracle Health Sciences Data Management Workbench - Demo ...

Oracle Health Sciences Data Management Workbench ... Their Clinical Trials Using Oracle ... Oracle Health Sciences InForm Data ...
Read more

Oracle Announces Pfizer's Selection of Oracle Cloud for ...

By using Oracle Health Sciences InForm ... Oracle Health Sciences Data Management Workbench ... and Oracle Health Sciences Clinical ...
Read more

Introduction - docs.oracle.com

Oracle® Health Sciences Data Management ... Oracle Health Sciences Data Management Workbench (Oracle ... creates the InForm source clinical data model ...
Read more

HOW ST. JUDE MEDICAL MANAGES ORACLE CLINICAL STUDIES USING ...

... St. Jude has been actively using BioPharm’s Oracle Clinical accelerator for various ... Clinical Data, Clinical Data Management System, ...
Read more