- - - - - 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 0 1 1 11 0 1 1 11 11 101 0 10 101 01 0 1 0 1 0 0 1 0 10 10 10 1 01 0 10 0 0 0 0 1 0 1 1 1 1 1 0 1 1 0 0 0 0 0 1 Oracle Health Sciences Data Management Workbench (DMW) Lab Vendors Patients Real-Time Access to Complete Investigators Make Critical Decisions Quickly Cleaning Submission Prep Clinical Programming Statistical Data Management BioStats Safety Medical 0 0 0 0 1111 11 011 10 0 0 0 0 10 1 01 0 10 1 01 0 1 010 1101 Clinical Trial Sponsors are looking for innovative ways to optimize clinical data flow by: • Consolidating data sources • Enabling data review and cleaning • Generating standards-based, submission-ready data sets Advanced technology is enabling faster, easier, and more accurate clinical trial data collection and validation than ever before. Regulatory and Trustworthy Trial Data to Partners Monitoring Analysis and Reporting Programming DATA Operational Monitoring Control Data Safety Data Aggregation 1 CROs Data Standards Clinical Ops OPTIMIZE CLINICAL DATA MANAGEMENT = • Make global trial set-up and ADVANCE CLINICAL TRIAL OPERATIONS STREAMLINE CLINICAL TRIAL DEVELOPMENT ENRICH BIOSTATS • Build and reuse custom and • Perform analysis earlier. Spot • Deliver validated data to biostats implementation easy with reusable workfows. trends and anomalies. Take corrective action sooner. standardized data models to streamline cleansing and • Enable consistent, deep data cleansing with consolidation of data sources. • Increase quality while minimizing manual processes with automated workflows and • transformation Simplify integration with data providers, such as CROs and advanced data acquisition/ central labs. transformation/cleansing. faster and easier. • Develop biostatistical analyses with clean, structure-ready, delivered data. With advanced data processing, DMW quickly delivers high-quality data with actionable insights. DMW accelerates the speed and accuracy of clinical trial set-up, as well as clinical data acquisition, reconciliation, aggregation and analysis. DMW’s single solution environment enables better data integration and facilitates easy adoption of industry standards. DMW delivers the right data, to the right teams, in the right structures. It frees biostatisticians to focus on rapid knowledge exploration to drive more successful submissions. ORACLE HEALTH SCIENCES DATA MANAGEMENT WORKBENCH (DMW) The industry’s only, true, end to end, clinical data management solution for data cleansing, integration and analysis. For more information visit: http://www.oracle.com/us/products/applications/health sciences/data management workbench/index.htm Copyright © 2018, Oracle and/or its affliates. All rights reserved. Oracle and Java are registered trademarks of Oracle and/or its affliates. Other names may be trademarks of their respective owners. 22239 032318