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

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
facebook.com/perficient twitter.com/Perficientlinkedin.com/company/perficient

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. 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
vicky.green@perficient.com

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
eherbel@i-review.com

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. • 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. 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. 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. www.i-review.com
The medical review tool which
supports ongoing collaboration
with all members of the
development team

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. 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. 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. 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. Questions?

15. Thank You!
For more information, please contact:
vicky.green@perficient.com (U.S.)
rudolf.coetzee@perficient.com (U.K.)
LifeSciencesInfo@perficient.com
+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