The Argus Safety System provides features for entering, managing, and reporting individual case safety data. It allows for rapid case entry with required fields and duplicate searching. Cases can be routed through a workflow and assigned to users or groups. The system generates various regulatory reports including MedWatch, CIOMS-I, and E2b. It also offers ad hoc reporting capabilities and templates for periodic reports like PSUR and PBRER. Dashboards display case and report information to help organize safety teams.
Salesforce Miami User Group Event - 1st Quarter 2024
Features of a World-Class Safety System
1. Features of a World-Class Safety System
Rodney Lemery, MPH, Ph.D., Director of Safety and Pharmacovigilance, Perficient
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2. 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. 3
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue $373 million
• Major market locations:
• Allentown, Ann Arbor, Atlanta, Boston, Charlotte, Chicago,
Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,
Houston, Indianapolis, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK),
Philadelphia, Southern California, St. Louis, Toronto,
Washington, D.C.
• Global delivery centers in China and India
• >2,600 colleagues
• Dedicated solution practices
• ~90% repeat business rate
• Alliance partnerships with major technology vendors
• Multiple vendor/industry technology and growth awards
Perficient Profile
4. Business Process
Management
Customer Relationship
Management
Enterprise Performance
Management
Enterprise Information
Solutions
Enterprise Resource
Planning
Experience Design
Portal / Collaboration
Content Management
Information Management
Mobile
BUSINESSSOLUTIONS
50+PARTNERS
Safety / PV
Clinical Data Management
Electronic Data Capture
Medical Coding
Clinical Data Warehousing
Clinical Data Analytics
Clinical Trial Management
Healthcare Data
Warehousing
Healthcare Analytics
CLINICAL/HEALTHCAREIT
Consulting
Implementation
Integration
Migration
Upgrade
Managed Services
Private Cloud Hosting
Validation
Study Setup
Project Management
Application Development
Software Licensing
Application Support
Staff Augmentation
Training
SERVICES
5. Agenda
• Case Entry
– Duplicate Search
– Various Data Points
– Generating Narratives
– Generating Letters
• Case Reporting
– Individual Case Safety Reporting
(ICSR)
• MedWatch
• CIOMS-I
• E2b
– Submission Tracking
• Case Management
– Workflow
– Worklists
– Dashboards
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• Ad Hoc Reports
– Case Data Analysis
– Case Line Listing
• Periodic Reporting
– ICH PSUR/PBRER
– NDA Periodic
6. Argus Safety System
• Io was a mortal woman and
lover of Zeus.
• Zeus' wife, Hera, was terribly
jealous, and Zeus fearing for Io's
life, turned her into a heifer to
escape Hera's gaze.
• But Hera was smart, and
knowing of this deception,
requested Io the heifer as a
present.
• She then sent the heifer to her
dedicated servant Argus
Panoptes, the all-seeing giant,
who has been described as
having 100 hundred eyes on his
body which allowed him to keep
a vigilant watch on Io the Heifer.
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8. Case Entry…
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The [Search] button takes the information entered and queries the
entire database for previously entered and matching cases to allow
for the addition of F/U information
9. Case Entry…
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The General tab contains entry fields for the reporter
information, case categorizations and initial & F/U records for
the case
10. Case Entry…
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The Patient tab contains the demographic information on the patient
of interest and allows for the recording of historical products,
conditions or procedures
11. Case Entry…
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The Product tab allows for the capture of indications and the specifics
around product administration
14. Case Entry…
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The system is loaded with a
rudimentary, but effective,
dictionary browser for both
the MedDRA and WHO Drug
dictionaries
15. Case Entry…
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A case may have more than one
event and they may be sequenced
in accordance with company rules
16. Case Entry…
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The Event Assessment sub-tab contains location where the
local labeledness, core listedness, and the reporter and
company causality records are stored with respect to the
suspect company product(s) and the events
17. Case Entry…
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The Analysis tab
contains the case
level assessments,
as well as the
various comment
and narrative
fields required in
global reporting
18. Case Entry…
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It is possible to build a comprehensive narrative that will take the
information entered into the case and pull it into a paragraphical
explanation of the case data
19. Case Entry…
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The Activities tab contains records of action items and contact
records used within the case entry/management process
20. Case Entry…
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The Contacts section also facilitates the generation and sending of
letter templates written in a template manner, similar to Auto-
Narrative functionality in Argus
21. Case Entry…
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The Action Items section contains the ability to assign
tasks to other users or groups, so that activities are
fully tracked with a start date, due date and completion
date
22. Case Entry…
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Among other things,
the Additional
Information tab
allows for the
attachment of
source
documentation to
the case, as well as
the ability to store it
directly in the
database (it can also
integrate to
Documentum)
24. Case Reporting…
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The Regulatory Reporting tab contains the critical records,
documenting the global reporting needs for the case based on stored
and configurable reporting rules per license and country
25. Case Reporting…
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Reports can be displayed while in the case entry form using the
hyperlinks. Final reports are generated only after locking a case
26. Case Reporting…
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The Regulatory Reports can be managed from this screen by routing
the report through a pre-defined workflow, once the final is generated
29. Case Management…
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Throughout the life of the case, the responsibilities can be shared with
various case processors/managers using the routing and workflow
features of Argus
30. Case Management…
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You can pass the case through the workflow using
the forward and return buttons as needed…
Bookin
Case Processing
Review
Reporting
Archive/
Close
F/U
31. Case Management…
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Each pass to the next step places the case into a New
Case Worklist so that case processors/managers can
accept the cases into their Open Case Worklists
32. Case Management…
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In general, all of the worklists allow for the certain completion of
tasks using the sub-menu from the screen that is contextually
sensitive to the worklist being accessed
Worklist New and Open Worklist Action Worklist Reports
33. Case Management…
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The Coding Review screen summarizes all of the medical or drug
coding required in the case in a single screen to allow the coder to
perform all work without navigating through the case entry tabs
34. Case Management…
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The Medical Review screen summarizes all of the clinically
relevant data that is often used in the formal medical review
process. The data is displayed as entry points or…
42. Ad Hoc Reporting…
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Argus has a built-in ad hoc reporting tool that facilitates the
generation of line listing and tabulation reports with relative
ease
43. Ad Hoc Reporting…
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The CDA report allows for the selection of case entered data
points to generate tabulated data
44. Ad Hoc Reporting…
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The reports can be displayed, memorized or transmitted to
others. The data format of the report can be exported to Excel
as well
45. Ad Hoc Reporting…
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The Charting
option will
display the
information in
various
graphical
formats
46. Ad Hoc Reporting…
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The Line Listing Report allows for the selection of case data
to be displayed in linear form which facilitates tasks like
reconciliation
47. Ad Hoc Reporting
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Line listing reports
have a major
limitation though, in
the display of
multiple rows of
data even when the
logic of the report
wishes the data to
be eliminated from
the display.
For example, if my listing wants to display all serious events and a given case has
two events (1 serious and 1 non), then both rows display on the report even when I
try to restrict it.
However, even with this limitation, the ability to easily generate your own ad hoc
reports with little to no IT assistance is likely worth it!
48. Periodic Reporting…
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Argus allows for the generation of the listings
and tabulations required in several global
periodic reports
You can create “templates” and reuse them or
copy from an old report
49. Periodic Reporting…
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The report allows for naming, categorization and selection of the
agencies to which the information will be submitted
56. Periodic Reporting…
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Users can also create their own user-defined listings and
tabulations using the Case Listing and Case Data Analysis
reports from Argus and then include them in the periodic report
57. Periodic Reporting…
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Once developed, the report can be drafted, reviewed and submitted
through the interface, but the work/drafting of the report is offset to
the transactional server, thus freeing processing speed for the
application server
58. Periodic Reporting
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Once printed in FINAL mode, all cases included in the periodic report
receive a submission record in their case for clear inclusion in the
report and its tracking
59. Summary
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• Argus provides a sleek interface allowing for the rapid entry,
management and reporting of individual case safety data
• Argus provides interfaces for the generation of ad hoc
listings and tabulations with little IT support
• Periodic reports are relatively easy to build and track within
the system
• Dashboards allow for the comfortable display of case, report
and management information to help your safety team stay
organized