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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
Vicky Green, Business Development Director, Life Sciences, PerficientEric Herbel, President, Integrated Clinical Systems
facebook.com/perficient twitter.com/Perficientlinkedin.com/company/perficient
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
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
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
PresidentIntegrated Clinical Systems
908-996-4600
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
• 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
Life SciencesP
ract
ices
/ S
olu
tio
ns
ImplementationMigration
Integration
ValidationConsultingUpgrades
Managed ServicesApplication Development
Private Cloud Hosting
Application SupportSub-licensingStudy Setup
Services
Deep Clinical and Pharmacovigilance Applications Expertise
Clinical TrialManagement
Clinical Trial Planning and BudgetingOracle ClearTrial
CTMSOracle Siebel CTMS / ASCEND
Mobile CRA
Clinical Data Management & Electronic Data Capture
CDMSOracle Clinical
Electronic Data CaptureOracle Remote Data Capture
Oracle InFormMedidata Rave
Medical CodingOracle Thesaurus Management System
Custom Application
Safety &Pharmacovigilance
Adverse Event ReportingOracle Argus Safety Suite
Oracle AERS / EmpiricaTraceAxway Synchrony Gateway
Signal ManagementOracle Empirica Signal/Topics
Medical CodingOracle Thesaurus Management System
Custom Application
Clinical DataWarehousing & Analytics
Clinical Data WarehousingOracle Life Sciences Data Hub
Clinical Data AnalyticsOracle Clinical Development Analytics
JReview
Data Review and CleaningOracle Data Management Workbench
Clients
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
www.i-review.com
The medical review tool which
supports ongoing collaboration
with all members of thedevelopment team
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
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.
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
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
Questions?
Thank You!
For more information, please contact:
[email protected] (U.S.)[email protected] (U.K.)
[email protected]+44 (0) 1865 910200 (U.K. Sales)
+1 877 654 0033 (U.S. Sales)
www.facebook.com/perficient
www.perficient.com
www.twitter.com/perficient_ls
