Your SlideShare is downloading. ×

Migrating from Oracle AERS to Argus Safety: Reasons for the Move

976
views

Published on

Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly …

Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness are unmatched.

Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.

Please join Perficient's Dr. Rodney Lemery, director of safety and pharmacovigilance, as he will:

Compare Argus Safety to AERS
Cover the options of effectively migrating to Argus Safety

Published in: Technology, Business

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
976
On Slideshare
0
From Embeds
0
Number of Embeds
9
Actions
Shares
0
Downloads
29
Comments
0
Likes
2
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. 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
  • 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. • 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
  • 4. BUSINESS SOLUTIONS Business Intelligence Business Process Management Customer Experience and CRM Enterprise Performance Management Enterprise Resource Planning Experience Design (XD) Management Consulting TECHNOLOGY SOLUTIONS Business Integration/SOA Cloud Services Commerce Content Management Custom Application Development Education Information Management Mobile Platforms Platform Integration Portal & Social Our Solutions Expertise
  • 5. Life SciencesPractices/Solutions Implementation Migration Integration Validation Consulting Upgrades Managed Services Application Development Private Cloud Hosting Application Support Sub-licensing Study Setup Services Deep Clinical and Pharmacovigilance Applications Expertise Clinical Trial Management Clinical Trial Planning and Budgeting Oracle ClearTrial CTMS Oracle Siebel CTMS / ASCEND Mobile CRA Clinical Data Management & Electronic Data Capture CDMS Oracle Clinical Electronic Data Capture Oracle Remote Data Capture Oracle InForm Medical Coding Oracle Thesaurus Management System Safety & Pharmacovigilance Adverse Event Reporting Oracle Argus Safety Suite Oracle AERS / EmpiricaTrace Axway Synchrony Gateway Signal Management Oracle Empirica Signal/Topics Medical Coding Oracle Thesaurus Management System Clinical Data Warehousing & Analytics Clinical Data Warehousing Oracle Life Sciences Data Hub Clinical Data Analytics Oracle Clinical Development Analytics JReview Data Review and Cleaning Oracle Data Management Workbench Clients
  • 6. Introduction Dr. Rodney Lemery Director of Safety and Pharmacovigilance Safety and Pharmacovigilance Life Sciences Business Unit rodney.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
  • 7. 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
  • 8. 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
  • 9. 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
  • 10. 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.
  • 11. 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
  • 12. Usability Improvements Between Argus and AERS Type ahead feature allows for rapid data entry
  • 13. Usability Improvements Between Argus and AERS Last accessed cases are available from a menu pick
  • 14. 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
  • 15. Usability Improvements Between Argus and AERS Medical event coding is arguably easier to perform via Argus interface….
  • 16. Usability Improvements Between Argus and AERS Drug coding is arguably easier to perform via Argus interface….
  • 17. Usability Improvements Between Argus and AERS Central event and drug coding interface is available for use without accessing the actual cases
  • 18. 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
  • 19. Usability Improvements Between Argus and AERS Attaching files to the case data is very easy in Argus compared to AERS 1 2 3
  • 20. 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
  • 21. Usability Improvements Between Argus and AERS This eliminates the cumbersome Portal technology of AERS.
  • 22. 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.
  • 23. Usability Improvements Between Argus and AERS The temporal view allows for visual confirmation of treatment emergent reactions.
  • 24. 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.
  • 25. Usability Improvements Between Argus and AERS There are even simplifications in the regulatory reporting tracking of the ICSR in Argus compared to AERS.
  • 26. Usability Improvements Between Argus and AERS
  • 27. 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.
  • 28. 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.
  • 29. Usability Improvements Between Argus and AERS A number of pre-built dashboards are available in Argus without the purchase of an additional reporting tool.
  • 30. Usability Improvements Between Argus and AERS Many of the dashboards are dynamic and allow drill-down.
  • 31. 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.
  • 32. 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.
  • 33. 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.
  • 34. 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.
  • 35. Usability Improvements Between Argus and AERS Split screen entry is allowed with English on one side and Japanese on the other.
  • 36. 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)
  • 37. Usability Improvements Between Argus and AERS
  • 38. 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
  • 39. 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.
  • 40. Administration and System Improvements Argus has simplified this process tremendously.
  • 41. Administration and System Improvements Codelist maintenance in AERS is cumbersome with different language types and other attributes.
  • 42. Administration and System Improvements The configuration of expedited reporting rules in AERS is limited.
  • 43. Administration and System Improvements Using the Advanced Condition aspect of Argus, the reporting rule configuration is impressive and expansive!
  • 44. Administration and System Improvements Periodic reporting is simplified in Argus from the build of the report through the tracking of its submission.
  • 45. 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.
  • 46. 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.
  • 47. 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.
  • 48. 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
  • 49. 6/13/2014 49
  • 50. www.facebook.com/perficient www.perficient.com www.twitter.com/perficient_LS Thank You! For more information, please contact: Rodney.Lemery@perficient.com LifeSciencesInfo@perficient.com (Sales) +44 (0) 1865 910200 (U.K. Sales) +1 877 654 0033 (U.S. Sales)

×