Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness are unmatched. Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions. Please join Perficient's Dr. Rodney Lemery, director of safety and pharmacovigilance, as he will: Compare Argus Safety to AERS Cover the options of effectively migrating to Argus Safety

1. Migrating from Oracle AERS to
Argus Safety: Reasons for the Move
Dr. Rodney Lemery, Director of Safety and Pharmacovigilance
Life Sciences Business Unit
facebook.com/perficient twitter.com/Perficient_LSlinkedin.com/company/perficient

2. 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

3. • Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
• Major market locations throughout North America
• Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland,
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

4. BUSINESS SOLUTIONS
Business Intelligence
Business Process Management
Customer Experience and CRM
Enterprise Performance Management
Enterprise Resource Planning
Experience Design (XD)
Management Consulting
TECHNOLOGY SOLUTIONS
Business Integration/SOA
Cloud Services
Commerce
Content Management
Custom Application Development
Education
Information Management
Mobile Platforms
Platform Integration
Portal & Social
Our Solutions Expertise

5. 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
Medical Coding
Oracle Thesaurus Management System
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
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

6. Introduction
Dr. Rodney Lemery
Director of Safety and Pharmacovigilance
Safety and Pharmacovigilance
Life Sciences Business Unit
rodney.lemery@perficient.com
• 13+ years with Perficient (via BioPharm
Systems)
• Leader of the team that implements, supports,
enhances and integrates various safety/PV
solutions
• Well over 75 safety system projects for
pharmaceutical, biotechnology and medical
device companies, in addition to clinical research
organizations (CROs) and academic
institutions (AROs) of all sizes

7. Agenda
• Benefits of Argus compared to AERS
– Usability
• Case management GUI
• Medical review
• Coding
• Report tracking
• Improved document management
– Documentum integration
– Attachments without the implementation of complex software (Oracle Portal)
• E2b support
• Dashboards
• Worklists
• Argus-J
• Unstructured case intake
– Administration
• User defined fields
• Expedited reporting rules
• Periodic report maintenance (off-loading to application server)
• Integrates to LDAP with no additional software

8. Usability Improvements
• Usability
– There are a number of items within the Argus application to which
one can argue more efficient case entry and management. The
following are a few we will look at in detail:
• Case management GUI
• Coding
• Improved document management
– Documentum integration
– Attachments without the implementation of complex software (Oracle
Portal)
• Expedited report tracking
• Medical review window
• E2b support
• Dashboards
• Worklists
• Argus-J

9. Usability Improvements Between
Argus and AERS
In general, the user interface responsible for case management is
perceived by many to be an easier system to navigate which may lead
to faster case management times. • Fewer tabs
• Fields more
structured in
organization

10. Usability Improvements Between
Argus and AERS
Keeping track of all the event/product assessments for a given case can
be cumbersome. An easy to read and acknowledge label evaluation is
important especially in global environments.

11. Usability Improvements Between
Argus and AERS
While these slides demonstrate
core labeling analysis, in a
global company local
labeling may be required.
– Argus allows this
assessment instantly by
clicking the (+) while
AERS is an additional
menu path

12. Usability Improvements Between
Argus and AERS
Type ahead feature allows
for rapid data entry

13. Usability Improvements Between
Argus and AERS
Last accessed cases are
available from a menu pick

14. Usability Improvements Between
Argus and AERS
• Additionally, you can have multiple Argus cases
open at the same time and toggle between them
– NOTE: This does not mean the case information for these multiple
cases are simultaneously visible, but that the cases can be jumped
between
– This is not available in AERS

15. Usability Improvements Between
Argus and AERS
Medical event coding is
arguably easier to perform
via Argus interface….

16. Usability Improvements Between
Argus and AERS
Drug coding is
arguably easier to
perform via Argus
interface….

17. Usability Improvements Between
Argus and AERS
Central event and drug coding interface is available for use
without accessing the actual cases

18. Usability Improvements Between
Argus and AERS
Out of the box, Argus is not integrated with a
complex dictionary management system (such
as TMS or DS Navigator)
– This results in far less complexity in dictionary
versioning and recoding efforts by IT and ultimately
may translate into a cost savings for the company

19. Usability Improvements Between
Argus and AERS
Attaching files to the case data is very easy in Argus
compared to AERS
1
2
3

20. Usability Improvements Between
Argus and AERS
Once attached the file is available from within the case
entry form
– NOTE: Argus also integrates easily with Documentum for
advanced document management capabilities

21. Usability Improvements Between
Argus and AERS
This eliminates the cumbersome Portal technology of AERS.

22. Usability Improvements Between
Argus and AERS
Similar to the coding review window, Argus provides a simplified
medical review window to assess the case and complete required
medical review.

23. Usability Improvements Between
Argus and AERS
The temporal view allows for visual confirmation of treatment
emergent reactions.

24. Usability Improvements Between
Argus and AERS
Finally, the medical review screen allows the review of attached
source documents and the display of the case data on any number of
individual case safety reports.

25. Usability Improvements Between
Argus and AERS
There are even simplifications in the regulatory reporting tracking of the
ICSR in Argus compared to AERS.

26. Usability Improvements Between
Argus and AERS

27. Usability Improvements Between
Argus and AERS
It has even been suggested that running reports is easier in Argus
compared to AERS.
– Report parameters are much more simplified in Argus.

28. Usability Improvements Between
Argus and AERS
Unlike AERS, the E2b report submission and tracking has its own
interface within the Argus application, making the review and
transmission of electronic data much easier to monitor.

29. Usability Improvements Between
Argus and AERS
A number of pre-built dashboards are available in Argus without the
purchase of an additional reporting tool.

30. Usability Improvements Between
Argus and AERS
Many of the dashboards are dynamic and allow drill-down.

31. Usability Improvements Between
Argus and AERS
Similarly, Argus allows the creation of ad hoc line listing, tabulation and
graphical reports without the purchase of additional reporting tools.

32. Usability Improvements Between
Argus and AERS
Another powerful difference between AERS and Argus is Argus’ ability
to tightly integrate to the configured workflow in order to appropriately
distribute the workload automatically.
• Worklist New visualizes all cases not yet assigned
to an individual or workflow group to which the
logged in user has access.

33. Usability Improvements Between
Argus and AERS
Another powerful difference between AERS and Argus is Argus’ ability
to tightly integrate to the configured workflow in order to appropriately
distribute the workload automatically.
• Worklist Open visualizes all cases assigned to an
individual or workflow group to which the logged in
user has access.

34. Usability Improvements Between
Argus and AERS
The closest similarity available in AERS are custom Inbox queries that
look at the workflow steps and privileges - a query which could be quite
complex and require advanced user assistance to build.

35. Usability Improvements Between
Argus and AERS
Split screen entry is allowed with
English on one side and Japanese
on the other.

36. Usability Improvements Between
Argus and AERS
• Japan Pharmaceutical Information Center (JAPIC )
• Releases datasets of cases of adverse event reports originating
within the literature for purchase
1. Load JAPIC data into Argus Safety
2. Manage as literature after loading (not as regular case
management)
3. Manage as literature/study reports. If determined to be
reportable to the authority, it will be moved to the normal
case reporting work-flow
4. Literature E2B (Including J Items)

37. Usability Improvements Between
Argus and AERS

38. Administration and System Improvements
• Administration
– Configuration of the Argus application is much easier and is
accomplished by the Argus Console GUI (very few exceptions).
• User defined fields
• Codelists
• Expedited reporting rules
• Periodic report maintenance (off-loading to application server)
• Integrates to LDAP with no additional software

39. Administration and System Improvements
• Adding user-defined fields in AERS can be a challenge, and while
you have a large amount of flexibility around the location of this data
point on the screen, it comes at a configuration cost.
• Argus has simplified this process tremendously.

40. Administration and System Improvements
Argus has simplified this process tremendously.

41. Administration and System Improvements
Codelist maintenance in AERS is cumbersome with different language
types and other attributes.

42. Administration and System Improvements
The configuration of expedited reporting rules in AERS is limited.

43. Administration and System Improvements
Using the Advanced Condition aspect of Argus, the reporting rule
configuration is impressive and expansive!

44. Administration and System Improvements
Periodic reporting is simplified in Argus from the build of the report
through the tracking of its submission.

45. Administration and System Improvements
• Tracking of generated reports and submitted ones are visible from the
same screen.
• This off loads the generation of the report to the server and improves
performance.

46. Administration and System Improvements
Another great feature of Argus compare to AERS is its native integration
to any LDAP system through configuration activities only without IT
intervention.

47. Summary
• In general, the user interface and administration/configuration
aspects of the Argus application provide a wonderful justification
for the cost incurred during a data migration.
– Usability improvements may save time in case management and
ultimately may result in higher regulatory reporting compliance
rates.
– Ad hoc reporting built into the system does not require additional
tools nor licenses and allows for rapid response to regulatory or
clinical questions.
– Configuration/administration ease allows end-users to manage
their own application with little input from IT users.

48. Additional Considerations
• License costs
• Total cost of ownership
– Server costs, supplemental software, etc.
• Data migration costs
• Software life expectancy
– According to Oracle, future enhancements and updates to the AERS
platform will be focused on the use of the system by regulatory authorities
and may not include functionality from the perspective of a bio-
pharmaceutical or medical device company
• Technology support limitations
– OS requirements or browsers requirements supplemental support of these
items

49. 6/13/2014 49

50. www.facebook.com/perficient
www.perficient.com
www.twitter.com/perficient_LS
Thank You!
For more information, please contact:
Rodney.Lemery@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+44 (0) 1865 910200 (U.K. Sales)
+1 877 654 0033 (U.S. Sales)