| Date post: | 14-Jul-2015 |
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Technology |
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Features of a World-Class Safety System
Rodney Lemery, MPH, Ph.D., Director of Safety and Pharmacovigilance, Perficient
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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
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• 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
Business Process Management
Customer Relationship Management
Enterprise Performance Management
Enterprise Information Solutions
Enterprise Resource Planning
Experience Design
Portal / Collaboration
Content Management
Information Management
Mobile
BU
SINESS SO
LUTIO
NS
50
+ PAR
TNER
S
Safety / PV
Clinical Data Management
Electronic Data Capture
Medical Coding
Clinical Data Warehousing
Clinical Data Analytics
Clinical Trial Management
Healthcare Data Warehousing
Healthcare Analytics
CLIN
ICA
L / HEA
LTHC
AR
E IT
Consulting
Implementation
Integration
Migration
Upgrade
Managed Services
Private Cloud Hosting
Validation
Study Setup
Project Management
Application Development
Software Licensing
Application Support
Staff Augmentation
Training
SERV
ICES
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
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…
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Case Actions New
Red-flagged boxes indicate required fields
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
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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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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The Product tab allows for the capture of indications and the specifics around 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, 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, as well as 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 and 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, as well as the ability to store it 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 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
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
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
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 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
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 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
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
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
Ad Hoc Reporting…
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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 be displayed 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!
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
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/drafting of 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
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
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Thank You!
For more information, please contact:
[email protected]@perficient.com (Sales)
+1 919 462 6395 (U.S. Sales)+44 (0) 1865 910200 (U.K. Sales)
www.facebook.com/perficient
www.perficient.com
www.twitter.com/perficient_LS
