Jumpstart your PV Operational Efficiency Improvement Initiatives through Oracle Pharmacovigilance Operational Analytics (OPVA)

I attended Oracle Open World (OOW) recently during the week of Oct 2nd. I got a sneak peek of the newly released Oracle Pharmacovigilance Operational Analytics tool. This tool is intended to provide a jumpstart to the efforts of Safety & Pharmacovigilance departments of MAHs and CROs in being able to monitor the operational performance of the organizations and identify the bottlenecks. The key point to note is that this tool provides only the Operational Analytics and doesn’t include the Scientific Analytics.

Some of the Key business benefits it will deliver include:

  • Insights into the case processing operations
  • Measure compliance and productivity across the organization
  • Provide ability to monitor the KPIs and metrics through dashboards in real time
  • Provide ability to drill down to identify the bottlenecks in the process
  • Improve productivity and save costs across the organization
  • Improve compliance and enable better patient safety

From IT Systems perspective:

  • Single repository of operational safety data
  • Star schemas that could be populated with data from internal and external sources
  • Predefined reports, KPIs, Metrics and Dashboards
  • Ability to customize and extend the dashboards and reports
  • Ability to view current as well as historical operational performance of organization and individuals
  • Out-of-the-box integration with Oracle’s Argus Safety
  • Built using Oracle BI (OBIEE) which gives ability to view dashboards on web as well as on mobile devices (iPhones and iPads)

Some of the key dashboards that are provided out-of-the-box:

  • Case processing history in terms of volumes, compliance and repetition
  • Case processing management in terms of volumes, compliance and workflow state SLA management
  • Personal user dashboards with individual’s case management and case history,

Some of the reports include:

  • Completed case volume overview and trends
  • Pending case volume overview and trends
  • Case version line listings
  • Individual case workload reports and line listings

OPVA is compatible with Argus Safety 6.0.2 and Argus Safety 7.0.

One of the key uses of OPVA for organizations that want to define additional metrics, KPIs, dashboards and reports is the start schema that is provided with the product. It comes with a set of predefined dimensions and facts that can be leveraged to speed up the process of developing the additional custom dashboards, KPIs, Metrics and Reports.

Dimensions provided by the OPVA schema are:

  • Period
  • Product
  • Study
  • List of Values
  • Users
  • User Group
  • Case Processing Site
  • Country
  • Enterprise (in a multi-tenant scenario more relevant for CROs)

The pre-built facts into the OPVA data mart are:

  • Case Version History
  • Case Routing History
  • Case Workflow History and
  • Pending Cases

I think this is a very good addition by Oracle to its stable of products and compliments the existing tools quite well. This is also a very good tool for customers wanting to jumpstart their efforts to measuring their safety operations (aka Case Processing), identifying the bottlenecks in terms of compliance and productivity and rein in costs through improvement plans to enhance these aspects.

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About Venu Mallarapu

I am currently working as Associate Director at Cognizant Technology Services in their Life Sciences division. I have over 15 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for about 9 years. I have worked with small to large pharma customers to address various business requirements in R&D, Sales and Marketing areas. IT Service Management is one of my other passions. I blog and write about technology frequently and have also presented at various conferences and workshops on wide variety of topics in technology.

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