Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Systems


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Sponsors and CROs naturally rely on various clinical and safety systems from a multitude of software vendors. However, continuously accessing disparate sources for the reporting, analysis, and monitoring of data can be a treacherous undertaking, if you don't have a solution that connects to them right out of the box.

That's where JReview comes in. For almost two decades, life sciences companies, research organizations, in addition to the government, have relied on JReview for the comprehensive analysis and monitoring of clinical and pharmacovigilance data.

The analytics solution works with many Oracle Health Sciences applications, including Argus Safety, Oracle AERS, Oracle Clinical (OC), Remote Data Capture (RDC), Thesaurus Management System (TMS), InForm, Life Sciences Data Hub (LSH), and Clinical Development Center (CDC). JReview also works with non-Oracle solutions, such as ARISg, Medidata Rave, and SAS Drug Development.

In this slideshare, you will learn:

The features and benefits of JReview, including the new functionality in v10.0 (e.g., risk-based monitoring analytics reporting on the clinical data itself, etc.)

Benefits of using JReview for:
Reporting and query of your clinical data
Supplying internal and/or external users/sponsors information
Providing a secure way for your internal users and/or sponsor users to access the clinical data

Examples of how customers use JReview with OC/RDC

The implementation process and options

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Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Systems

  1. 1. Using JReview to Analyze Clinical and Pharmacovigilance Data in Disparate Systems Vicky Green, Business Development Director, Life Sciences, Perficient Eric Herbel, President, Integrated Clinical Systems
  2. 2. Agenda • Agenda • Introductions • Background of Perficient and our Life Sciences solutions • Background of JReview® hosted by Perficient • Why JReview? • What’s new in version 10? • Overview demonstration of JReview • Q&A
  3. 3. Introduction Experience with Clinical and Safety Applications since 1990 • 20+ years with Quintiles, INC Research, CSS Informatics, BioPharm Systems, Perficient • Responsible for business development across all life sciences applications and services • Responsible for working with hosting and support customers • Intimate knowledge of the interoperability of clinical and safety applications • Keen awareness of the clinical technology ecosystem, validation, and business operations within the life sciences industry Vicky Green Business Development Director Life Sciences Perficient 919-462-6395
  4. 4. Introduction Founded ICS in 1994 • 17 years with Hoechst Roussel Pharmaceuticals (now part of Sanofi) - Director, Medical Systems • Founded ICS – focus on developing software for clinical research, specifically clinical data review • Principal architect of Integrated Review™ and a developer of JReview® Eric Herbel President Integrated Clinical Systems 908-996-4600
  5. 5. Perficient is a leading information technology consulting firm serving clients throughout North America and Europe. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities. About Perficient
  6. 6. • Founded in 1997 • Public, NASDAQ: PRFT • 2013 revenue ~$373 million • Major market locations throughout North America Atlanta, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, New York City, Northern California, Philadelphia, Southern California, St. Louis, Toronto and Washington, D.C. • Global delivery centers in China, Europe and India • >2,100 colleagues • Dedicated solution practices • ~85% repeat business rate • Alliance partnerships with major technology vendors • Multiple vendor/industry technology and growth awards Perficient Profile
  7. 7. Life SciencesPractices/Solutions Implementation Migration Integration Validation Consulting Upgrades Managed Services Application Development Private Cloud Hosting Application Support Sub-licensing Study Setup Services Deep Clinical and Pharmacovigilance Applications Expertise Clinical Trial Management Clinical Trial Planning and Budgeting Oracle ClearTrial CTMS Oracle Siebel CTMS / ASCEND Mobile CRA Clinical Data Management & Electronic Data Capture CDMS Oracle Clinical Electronic Data Capture Oracle Remote Data Capture Oracle InForm Medidata Rave Medical Coding Oracle Thesaurus Management System Custom Application Safety & Pharmacovigilance Adverse Event Reporting Oracle Argus Safety Suite Oracle AERS / EmpiricaTrace Axway Synchrony Gateway Signal Management Oracle Empirica Signal/Topics Medical Coding Oracle Thesaurus Management System Custom Application Clinical Data Warehousing & Analytics Clinical Data Warehousing Oracle Life Sciences Data Hub Clinical Data Analytics Oracle Clinical Development Analytics JReview Data Review and Cleaning Oracle Data Management Workbench Clients
  8. 8. Private Cloud Hosting • JReview and related life sciences applications (e.g., Argus Safety, Oracle Clinical, Remote Data Capture, Thesaurus Management System, Clinical Development Analytics, Axway Synchrony Gateway, Empirica Signal and Topics, Life Sciences Data Hub, etc.) are managed, maintained, and supported in a state-of-the-art data center. • Eliminates the hassle, cost, and resources required to purchase and maintain your own equipment. • Provides experts to help support the systems/infrastructure and applications (e.g., help desk, functional support, technical support, etc.) • Allows customers to utilize their existing JReview licenses, add new perpetual licenses, or discuss purchasing licenses on a sub-licensing basis. Services Offered to Customers via Perficient/ICS Partnership • Implementation and validation • System administration (e.g., monitoring, performance, server maintenance, etc.) • Technical application/Oracle DBA support • Application support, including Tier 1 and Tier 2 functional • Disaster recovery – Standby mirror of production (optional, if required) • Training and/or consulting • JReview software licenses based on the module that fits your organization JReview® Hosted by Perficient
  9. 9. The medical review tool which supports ongoing collaboration with all members of the development team
  10. 10. JReview Unique Capabilities Developed from day 1 as a Clinical application • Understands ‘patient’, ‘baseline’, ‘endpoint’, etc. • Integrated with many clinical data sources • Dynamic multi-study pooling • Built-in ‘patient identification/drill down’ • Patient review tracking • Many clinical data specific graphics, tabulations, profiles, risk assessments, etc. including defining critical data • Built-in codelist/sas format awareness • SAS program /R script integration • Patient narratives • Risk-based monitoring and SDV
  11. 11. JReview – Clinical Data Sources Integrated with many clinical data sources – consistent UI • Data Management Systems: Oracle Clinical, Oracle Clintrial • EDC Systems: Medidata Rave, Oracle InForm (reporting database), DataLabs • Drug Safety Systems: Oracle Argus, ARISg, Oracle AERS • Data Warehouse Environments: Oracle LSH (JReview built-in LSH ‘connector’) Entimo EntimICE eClinical Solutions eGrex SAS Drug Development FDA – JANUS/CTR (new environment) • SAS environments – ‘pure SAS environment’ • Custom configured customer database environments • CTMS data via dblink, etc.
  12. 12. JReview - Major Strengths • Intuitive, easy-to-use • Clinical application • Comprehensive functionality for clinical researcher • Tightly integrated result displays • Excellent performance • Very low setup and administration via Data Dictionary awareness • Growing installed base – majority of Pharma & CROs includes DHHS (FDA, NIH, NCI especially) • Japanese localized version available since 1997 14 companies in Japan currently installed • Chinese localized version available now
  13. 13. JReview version 10 • Risk Based Monitoring Analysis Risk Indicators, Threshold Definitions within JReview Periodic Analyses • Risk-Based Monitoring Visualization Risk-Based Monitoring Data Browser Current State Visualization Historical Trends • Graphic Browser – New Graph Type Trellis Plots – Timeline Trellis by Patient or Patient Groups • Many Other Enhancements
  14. 14. Questions?
  15. 15. Thank You! For more information, please contact: (U.S.) (U.K.) +44 (0) 1865 910200 (U.K. Sales) +1 877 654 0033 (U.S. Sales)