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
|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.
Wikipedia defines Predictive Analytics, as “Predictive analytics encompasses a variety of statistical techniques from modeling, machine learning, data mining and game theory that analyze current and historical facts to make predictions about future events.” While not all of the techniques stated above are required, a lot of data mining and statistical analysis need to be performed on historical data before one can predict the future trends and outcomes. The accuracy of the prediction depends on the variables and assumptions considered and will be the key to making accurate predictions of risks and opportunities.
Case in point, the volume of cases that come in for a product safety case processing organization varies depending on many factors. The variance could be due to factors like Seasonality of Adverse Events, A news item discussing potential side effects of a product, A blog post by a physician or some influential group or organization so on and so forth. With the ever increasing cost pressures on life sciences organizations, it is very difficult to plan for peak volumes while there will be additional unused capacity during the troughs. This is the kind of situation where any organization can use some predictability so they can plan the capacity within a reasonable deviation thus normalizing the peaks and troughs.
Imagine an business intelligence solution that can mine the historical case volumes and the corresponding capacity in conjunction with the process efficiency and be able to predict the future capacity requirements. Add the ability to evaluate some ‘What if” scenarios where one can change variable like case volumes and be able to predict the capacity requirements. While this may sound like a “Holy Grail”, it is possible with some of the sophisticated tools available. A screenshot of one such solution below:
Do you have a need for such solution in your organization? Have you built a predictive analytics solution for other purposes? Please share your feedback and inputs.
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:
- List of Values
- User Group
- Case Processing Site
- 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.