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Features of a World-Class Safety System

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A common goal of life sciences companies is to capture essential adverse event data efficiently. The use of automated systems to document and track this information is proving to be essential in the safety field.

Perficient’s Dr. Rodney Lemery, director of safety and pharmacovigilance, reviewed various features of Oracle’s Argus Safety solution that can assist you in your safety and pharmacovigilance practices.

Published in: Technology
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Features of a World-Class Safety System

  1. 1. Features of a World-Class Safety System Rodney Lemery, MPH, Ph.D., Director of Safety and Pharmacovigilance, Perficient facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient
  2. 2. 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. 3. 3 • 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
  4. 4. Business Process Management Customer Relationship Management Enterprise Performance Management Enterprise Information Solutions Enterprise Resource Planning Experience Design Portal / Collaboration Content Management Information Management Mobile BUSINESSSOLUTIONS 50+PARTNERS Safety / PV Clinical Data Management Electronic Data Capture Medical Coding Clinical Data Warehousing Clinical Data Analytics Clinical Trial Management Healthcare Data Warehousing Healthcare Analytics CLINICAL/HEALTHCAREIT Consulting Implementation Integration Migration Upgrade Managed Services Private Cloud Hosting Validation Study Setup Project Management Application Development Software Licensing Application Support Staff Augmentation Training SERVICES
  5. 5. 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 1/30/2015 5 • Ad Hoc Reports – Case Data Analysis – Case Line Listing • Periodic Reporting – ICH PSUR/PBRER – NDA Periodic
  6. 6. 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. 1/30/2015 6
  7. 7. Case Entry… 1/30/2015 7 Case Actions  New Red-flagged boxes indicate required fields
  8. 8. Case Entry… 1/30/2015 8 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
  9. 9. Case Entry… 1/30/2015 9 The General tab contains entry fields for the reporter information, case categorizations and initial & F/U records for the case
  10. 10. Case Entry… 1/30/2015 10 The Patient tab contains the demographic information on the patient of interest and allows for the recording of historical products, conditions or procedures
  11. 11. Case Entry… 1/30/2015 11 The Product tab allows for the capture of indications and the specifics around product administration
  12. 12. Case Entry… 1/30/2015 12 Multiple dosing regimens can be captured for complex products such as oncology products
  13. 13. Case Entry… 1/30/2015 13 The Event tab contains the details for the event of interest in the case
  14. 14. Case Entry… 1/30/2015 14 The system is loaded with a rudimentary, but effective, dictionary browser for both the MedDRA and WHO Drug dictionaries
  15. 15. Case Entry… 1/30/2015 15 A case may have more than one event and they may be sequenced in accordance with company rules
  16. 16. Case Entry… 1/30/2015 16 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
  17. 17. Case Entry… 1/30/2015 17 The Analysis tab contains the case level assessments, as well as the various comment and narrative fields required in global reporting
  18. 18. Case Entry… 1/30/2015 18 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
  19. 19. Case Entry… 1/30/2015 19 The Activities tab contains records of action items and contact records used within the case entry/management process
  20. 20. Case Entry… 1/30/2015 20 The Contacts section also facilitates the generation and sending of letter templates written in a template manner, similar to Auto- Narrative functionality in Argus
  21. 21. Case Entry… 1/30/2015 21 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
  22. 22. Case Entry… 1/30/2015 22 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)
  23. 23. Case Entry 1/30/2015 23 Once attached, the object is available for direct review within the case
  24. 24. Case Reporting… 1/30/2015 24 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
  25. 25. Case Reporting… 1/30/2015 25 Reports can be displayed while in the case entry form using the hyperlinks. Final reports are generated only after locking a case
  26. 26. Case Reporting… 1/30/2015 26 The Regulatory Reports can be managed from this screen by routing the report through a pre-defined workflow, once the final is generated
  27. 27. Case Reporting… 1/30/2015 27 Once approved, the report may be submitted and the submission date documented
  28. 28. Case Reporting 1/30/2015 28 The following ICSRs are capable of being produced and tracked within the system:
  29. 29. Case Management… 1/30/2015 29 Throughout the life of the case, the responsibilities can be shared with various case processors/managers using the routing and workflow features of Argus
  30. 30. Case Management… 1/30/2015 30 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
  31. 31. Case Management… 1/30/2015 31 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
  32. 32. Case Management… 1/30/2015 32 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
  33. 33. Case Management… 1/30/2015 33 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
  34. 34. Case Management… 1/30/2015 34 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…
  35. 35. Case Management… 1/30/2015 35 …visually as a timeline with filters
  36. 36. Case Management… 1/30/2015 36 Argus comes with a variety of pre-loaded dashboard reports to aid in case management
  37. 37. Case Management… 1/30/2015 37 List of Open Cases and where they are in the workflow
  38. 38. Case Management… 1/30/2015 38 Quick Signal Report shows a six-month comparison interval
  39. 39. Case Management… 1/30/2015 39 Expedited Reports display in an interactive form and allow easy review of reports and their statuses
  40. 40. Case Management… 1/30/2015 40 You can get a visual representation of where cases are in the workflow using the dashboard
  41. 41. Case Management 1/30/2015 41 Case Workload status and distribution can be displayed in the system or exported to Excel
  42. 42. Ad Hoc Reporting… 1/30/2015 42 Argus has a built-in ad hoc reporting tool that facilitates the generation of line listing and tabulation reports with relative ease
  43. 43. Ad Hoc Reporting… 1/30/2015 43 The CDA report allows for the selection of case entered data points to generate tabulated data
  44. 44. Ad Hoc Reporting… 1/30/2015 44 The reports can be displayed, memorized or transmitted to others. The data format of the report can be exported to Excel as well
  45. 45. Ad Hoc Reporting… 1/30/2015 45 The Charting option will display the information in various graphical formats
  46. 46. Ad Hoc Reporting… 1/30/2015 46 The Line Listing Report allows for the selection of case data to be displayed in linear form which facilitates tasks like reconciliation
  47. 47. Ad Hoc Reporting 1/30/2015 47 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!
  48. 48. Periodic Reporting… 1/30/2015 48 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
  49. 49. Periodic Reporting… 1/30/2015 49 The report allows for naming, categorization and selection of the agencies to which the information will be submitted
  50. 50. Periodic Reporting… 1/30/2015 50 Products can be selected and targeted if needed
  51. 51. Periodic Reporting… 1/30/2015 51 Options for inclusion criteria allow you to tightly focus on the data responsible for the report
  52. 52. Periodic Reporting… 1/30/2015 52 The system allows for the indication of AEs of Special Interest on the report
  53. 53. Periodic Reporting… 1/30/2015 53 A user can decide what additional fields of information should display on the listing sections of the report
  54. 54. Periodic Reporting… 1/30/2015 54 The report also allows for the grouping of the data by certain fields
  55. 55. Periodic Reporting… 1/30/2015 55 The PBRER tables are also included in the PSUR report, as well as a number of summary tabulations
  56. 56. Periodic Reporting… 1/30/2015 56 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
  57. 57. Periodic Reporting… 1/30/2015 57 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
  58. 58. Periodic Reporting 1/30/2015 58 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
  59. 59. Summary 1/30/2015 59 • 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
  60. 60. 1/30/2015 60
  61. 61. Thank You! For more information, please contact: Rodney.Lemery@perficient.com LifeSciencesInfo@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

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