Safety Analytics – What does Oracle Argus Analytics bring to the table?

Many large Drug Safety organizations have initiatives to leverage the historical data available to them and measure the operational inefficiencies of their processes. In my opinion these initiatives are worth spending your dollar. With the increased scrutiny by regulators on patient safety, drastic increase of data sources and dwindling budgets, the more you know about how good or bad you are at managing your processes to handle safety cases is worth the investment.The challenge always is with deciding what do you want to measure beyond your typical KPIs that you’d get from standard reports made available by the drug safety system vendors. Also, how flexible is the tool in making it easy for your team to define additional KPIs, create dashboards/reports and combine historical data with current data to perform comparative analysis.

Oracle has quickly established themselves as a leader in the Drug Safety space through acquisition of Relsys and Phaseforward. They probably have 3x the customers compared to their nearest competitor for all of their three safety systems. While this creates confusion in the short term, Argus Safety is emerging as the strategic product that they would support and continue enhancements in the long run. One of the initiatives that has come to fruition around this tool is Argus Analytics (formerly Oracle Pharmacovigilance Analytics ot OPVA) which has been available as a general release for close to 2 years now. While it demands additional investment from sponsors, I think it is a good starting point for any sponsor or CRO trying to measure their operational efficiency, identify bottlenecks and improve their decision making process.

I will keep this post brief and not go into the details of each KPI/Dashboard that is available in Oracle Argus Analytics and give a list of dashboards available. Many of these are self explanatory. More information can be found in the user guide available online here: http://docs.oracle.com/cd/E35225_01/doc.11/e29106/toc.htm

Dashboard	Type	Filter	Pages (Tabs)
Case Processing History	Trailing	Enterprise ID	Case Processing Volume History
			Case Processing Compliance History
			Workflow State Repetition History
Case Processing Management	Current	Enterprise ID	Case Processing Volume Management
			Case Processing Compliance Management
			Workflow State Compliance Management
Personal User Dashboard	Trailing & Current	Enterprise ID	Personal User Case History
			Personal User Case Management
			Personal User Case Work History
			Personal User Expedited Report History
			Personal User Expedited Report Management
Expedited Report History			Expedited Submission Volume History
			Expedited Non-Submission Volume History
			Expedited Submission Compliance History
Expedited Report Management			Expedited Submission Volume Management
			Expedited Submission Compliance Management
			Expedited Failed/Pending ACK Volume Management
Case Work History			Case Modified History
			Case Unmodified History
			Case Read History
			Case Idle History

Hope this gives a high level idea about the various dashboards available in Argus Analytics.

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 2^nd. 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.