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

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Introduction

Dr. Rodney Lemery

Director of Safety and PharmacovigilanceSafety and Pharmacovigilance

Life Sciences Business Unitrodney.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

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

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.

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

Usability Improvements Between Argus and AERS

Type ahead feature allows for rapid data entry

Usability Improvements Between Argus and AERS

Last accessed cases are available from a menu pick

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

Usability Improvements Between Argus and AERS

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

Usability Improvements Between Argus and AERS

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

Usability Improvements Between Argus and AERS

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

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

Usability Improvements Between Argus and AERS

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

1

2

3

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

Usability Improvements Between Argus and AERS

This eliminates the cumbersome Portal technology of AERS.

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.

Usability Improvements Between Argus and AERS

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

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.

Usability Improvements Between Argus and AERS

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

Usability Improvements Between Argus and AERS

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.

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.

Usability Improvements Between Argus and AERS

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

Usability Improvements Between Argus and AERS

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

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.

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.

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.

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.

Usability Improvements Between Argus and AERS

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

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)

Usability Improvements Between Argus and AERS

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

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.

Administration and System Improvements

Argus has simplified this process tremendously.

Administration and System Improvements

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

Administration and System Improvements

The configuration of expedited reporting rules in AERS is limited.

Administration and System Improvements

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

Administration and System Improvements

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

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.

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.

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

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Thank You!

For more information, please contact:

Rodney.Lemery@perficient.comLifeSciencesInfo@perficient.com (Sales)

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