Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs. In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.

1. HOW ORACLE ARGUS SAFETY 8.X SUPPORTS
PRODUCT SAFETY NEEDS

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ABOUT PERFICIENT
Perficient is the leading digital transformation
consulting firm serving Global 2000 and
enterprise customers.
With unparalleled information technology, management
consulting, and creative capabilities, Perficient and its
Perficient Digital agency deliver vision, execution, and
value with outstanding digital experience, business
optimization, and industry solutions.

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PERFICIENT PROFILE
Founded in 1997
Public, NASDAQ: PRFT
2015 revenue $473.6 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
Chattanooga, Chicago, Cincinnati, Columbus,
Dallas, Denver, Detroit, Fairfax, Houston,
Indianapolis, Lafayette, Milwaukee, Minneapolis,
New York City, Northern California, Oxford (UK),
Southern California,
St. Louis, Toronto
Global delivery centers in China and India
>2,800 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards

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AGENDA
• Case Entry
– Duplicate Search
– Various Data Points
– Generating Narratives
– Generating Letters
• Case Reporting
– Individual Case Safety Reporting
• MedWatch
• CIOMS-I
• E2B(R3)
– Submission Tracking
• Case Management
– Workflow
– Worklists
– Dashboards
• Ad Hoc Reports
– Case Data Analysis
– Case Line Listing
• Periodic Reporting
– ICH PSUR/PBRER
– NDA Periodic

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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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CASE ENTRY
Case Actions  New
Red flagged boxes indicate required fields

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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
CASE ENTRY

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A list of potential duplicate cases appear below so that you can fish through the
list opening those that you think are duplicate and either enter F/U or reject the
candidate and move to the next for review
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
CASE ENTRY

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GENERAL TAB
• The General Tab contains all of the general information in the case. Initial reporting
dates are captured in the Initial Received Date field.
• Follow-ups are dictated by the addition of follow-up records in the Follow-ups box.

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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
CASE ENTRY

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Medically Confirmed is now an explicit field on the screen
This is explicit to E2B(R3), so the health care professional fields in the reporter tabs still
need to be answered appropriately for E2B(R2) (if still in use)
CASE ENTRY

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The Product tab allows for the capture of indications and the specifics around
the product administration
CASE ENTRY

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Multiple dosing regimens can be captured for complex products such as
oncology products
CASE ENTRY

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The Event tab contains the details for the
event of interest in the case.
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
CASE ENTRY

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A case may have more than one event and
they may be sequenced in accordance with
company rules
CASE ENTRY

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The Event Assessment sub-tab contains location where the local labeledness,
the core listedness and the reporter and company causality records are stored
with respect to the suspect company product(s) and the events
CASE ENTRY

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The Analysis tab
contains the case level
assessments and the
various comment and
narrative fields required
in global reporting
CASE ENTRY

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It is possible to build a comprehensive narrative that will take the information
entered into the case an pull it into a paragraphical explanation of the case data
CASE ENTRY

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The Activities tab contains records of action items and contact records used
within the case entry/management process
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
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
CASE ENTRY

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Among other things, the
Additional Information tab
allows for the attachment of
source documentation to the
case and storage directly in
the database (it can also
integrate to Documentum)
CASE ENTRY

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Once attached, the object is available for direct review within the case
CASE ENTRY

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CASE REPORTING
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

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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
CASE REPORTING

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The Regulatory Reports can be managed from this screen through routing the report
through a pre-defined workflow, once the final is generated
CASE REPORTING

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Once Approved the report may be submitted and the submission date documented.
CASE REPORTING

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The following ICSRs are capable of being produced and tracked within the system:
CASE REPORTING

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Once the case is locked, the final (non-watermarked) reports are generated. In a global
database (Argus and Argus-J activated), the symbols next to the report name indicate if the
report is a global report or one specific to the local Japanese agency
This functionality allows the stabilization of the case data and finalization of all global
reports without negatively affecting the reporting obligations specific to Japan
CASE REPORTING

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The following is taken from the Oracle User Guide directly:
CASE REPORTING

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E2B(R3)
Unlike the ICH E2B(R2) standard, the E2B(R3) standard is an HL7 formatted file for
electronic submission
Argus uses the same Interchange/ESM functionality to generate the E2B(R3) file as it does
for E2B(R2)
A considerable change has been introduced for importing E2B(R3) data into Argus. This
technical solution first translates the R3 data into an R2 format before using the same
Interchange/ESM functionality to import the E2B(R3) file as it does for E2B(R2)
NOTE: The use of both E2B(R2) and R3 simultaneously may mean some case entry work
instructions are required to maintain consistent data transmitted

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To facilitate data
migrations or complex
integrations or perhaps
even placeholders used in
letter templates, new
custom codelists can be
created and maintained
here.
E2B(R3)

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To accommodate value differences between R2 and R3, the flexible re-categorization area
has been used to map the values between new R3 fields and existing R2
E2B(R3)

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Once generated, the E2B report can be viewed from within the application using the E2B
viewer (XML, Decoded or HL7 view)
E2B(R3)

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eVAERS
Similar to E2B(R3), the CBER required eVAERS report is also available in Argus 8.0; uses
the XML viewer as described above

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In Argus 8.0.1 the introduction of the Electronic Medical Device Report (eMDR) in HL7
format has been introduced!
eMDR

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E2B REPORT DISTRIBUTION
The E2B(R2)/R3 and VAERS files are transmitted using the
standard E2B submission mechanism (WorklistBulk E2B
Transmit)

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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
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
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
CASE MANAGEMENT

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In general, all of the worklists allow for 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
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
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…
CASE MANAGEMENT

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…visually as a timeline with filters
CASE MANAGEMENT

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Argus comes with a variety of pre-loaded dashboard reports to aid in case management
CASE MANAGEMENT

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List of Open Cases and where they are in the workflow
CASE MANAGEMENT

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Quick Signal Report shows a six month comparison interval
CASE MANAGEMENT

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Expedited Reports display in an interactive form and allow easy review of reports and
their statuses
CASE MANAGEMENT

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You can get a visual representation of where cases are in the workflow using the
dashboard
CASE MANAGEMENT

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Case Workload status and distribution can be displayed in the system or exported to
Excel
CASE MANAGEMENT

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AD-HOC REPORTING
Argus has a built-in ad hoc reporting tool that facilitates the generation of line listing and
tabulation reports with relative ease

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The CDA report allows for the selection of case entered data points to generate tabulated
data
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
AD-HOC REPORTING

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The Charting option
will display the
information in various
graphical formats
AD-HOC REPORTING

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The Line Listing Report allows for the selection of case data to display in linear form
which facilitates tasks like reconciliation
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!
AD-HOC 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
PERIODIC REPORTING

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The report allows for naming, categorization and selection of the agencies to which the
information will be submitted
PERIODIC REPORTING

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Products can be selected and targeted if needed
PERIODIC REPORTING

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Options for inclusion criteria allow you to tightly focus on the data responsible for the
report
PERIODIC REPORTING

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The system
allows for the
indication of AEs
of Special Interest
on the report
PERIODIC REPORTING

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A user can decide what additional fields of information should display on the listing
sections of the report
PERIODIC REPORTING

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The report also allows for the grouping of the data by certain fields
PERIODIC REPORTING

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The PBRER tables are also included in the PSUR report as well as a number of summary
tabulations
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
PERIODIC REPORTING

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Once developed, the report can be drafted, reviewed and submitted through the interface
but the work of the drafting is the report is offset to the transactional server thus freeing
processing speed for the application server
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
PERIODIC REPORTING

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In Argus 8.0, the system is integrated to the BI Publisher aspect of Oracle OBIEE
Out of the box, three BI reports are given and available for full modification:
DSUR
PSUR
PMAR
BI PUBLISHER PERIODIC REPORTING

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The data models are fully available in the BI Publisher tool
BI PUBLISHER PERIODIC REPORTING

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The reports that make up the final DSUR report are all
available for viewing/modification as well
BI PUBLISHER PERIODIC REPORTING

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SUMMARY
• Argus provides a sleek interface allowing for the rapid entry, management and
reporting of individual case safety data.
• HL7 file reporting
– E2B(R3)
– eVAERS
– Argus 8.0.1 includes eMDR reports
• Integrated to BI Publisher
• 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

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QUESTIONS?

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THANK YOU