migrating from oracle aers to argus safety: reasons for the move

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

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

• 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

BUSINESS SOLUTIONSBusiness IntelligenceBusiness Process ManagementCustomer Experience and CRMEnterprise Performance ManagementEnterprise Resource PlanningExperience Design (XD)Management Consulting

TECHNOLOGY SOLUTIONSBusiness Integration/SOACloud ServicesCommerceContent ManagementCustom Application DevelopmentEducationInformation ManagementMobile PlatformsPlatform IntegrationPortal & Social

Our Solutions Expertise

Life SciencesP

ract

ices

/ S

olu

tio

ns

ImplementationMigration

Integration

ValidationConsultingUpgrades

Managed ServicesApplication Development

Private Cloud Hosting

Application SupportSub-licensingStudy Setup

Services

Deep Clinical and Pharmacovigilance Applications Expertise

Clinical TrialManagement

Clinical Trial Planning and BudgetingOracle ClearTrial

CTMSOracle Siebel CTMS / ASCEND

Mobile CRA

Clinical Data Management & Electronic Data Capture

CDMSOracle Clinical

Electronic Data CaptureOracle Remote Data Capture

Oracle InForm

Medical CodingOracle Thesaurus Management System

Safety &Pharmacovigilance

Adverse Event ReportingOracle Argus Safety Suite

Oracle AERS / EmpiricaTraceAxway Synchrony Gateway

Signal ManagementOracle Empirica Signal/Topics

Medical CodingOracle Thesaurus Management System

Clinical DataWarehousing & Analytics

Clinical Data WarehousingOracle Life Sciences Data Hub

Clinical Data AnalyticsOracle Clinical Development Analytics

JReview

Data Review and CleaningOracle Data Management Workbench

Clients

Introduction

Dr. Rodney Lemery

Director of Safety and PharmacovigilanceSafety and Pharmacovigilance

Life Sciences Business [email protected]

• 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

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

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

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


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.


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


Type ahead feature allows for rapid data entry


Last accessed cases are available from a menu pick


• 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


Medical event coding is arguably easier to perform via Argus interface….


Drug coding is arguably easier to perform via Argus interface….


Central event and drug coding interface is available for use without accessing the actual cases


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


Attaching files to the case data is very easy in Argus compared to AERS

1

2

3


Once attached the file is available from within the case entry form

– NOTE: Argus also integrates easily with Documentum for advanced document management capabilities


This eliminates the cumbersome Portal technology of AERS.


Similar to the coding review window, Argus provides a simplified medical review window to assess the case and complete required medical review.


The temporal view allows for visual confirmation of treatment emergent reactions.


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.


There are even simplifications in the regulatory reporting tracking of the ICSR in Argus compared to AERS.


It has even been suggested that running reports is easier in Argus compared to AERS.

– Report parameters are much more simplified in Argus.


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.


A number of pre-built dashboards are available in Argus without the purchase of an additional reporting tool.


Many of the dashboards are dynamic and allow drill-down.


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


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.


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.


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.


Split screen entry is allowed with English on one side and Japanese on the other.


• 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)

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


• 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.


Argus has simplified this process tremendously.


Codelist maintenance in AERS is cumbersome with different language types and other attributes.


The configuration of expedited reporting rules in AERS is limited.


Using the Advanced Condition aspect of Argus, the reporting rule configuration is impressive and expansive!


Periodic reporting is simplified in Argus from the build of the report through the tracking of its submission.


• 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.


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

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.

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

04/10/2023 49

www.facebook.com/perficient

www.perficient.com

www.twitter.com/perficient_LS

Thank You!

For more information, please contact:

[email protected]@perficient.com (Sales)

+44 (0) 1865 910200 (U.K. Sales)+1 877 654 0033 (U.S. Sales)

migrating from oracle aers to argus safety: reasons for the move

Technology

argus application

faster case management

pharmacovigilance safety

usability improvements

business processes

aers type

rapid data entry

new business opportunities