Tag Archive | safety data warehouse

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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Social Media and Drug Safety, arranged marriage?

Social media is all about freedom of expression. safety and Pharmacovigilance is about patient safety and utmost confidentiality of patient information and not to mention the huge financial implications of misinformation. Having said that, life sciences organizations have recognized the need for proactively managing risk and having access to information related to patient safety, good or bad, before anybody else. In the light of this realization, there is tremendous pressure on heads of safety to formulate a social media strategy. While there is anxiety on their part as to the implications of such a strategy in terms of cost, productivity and compliance they are also grappling with not having the right guidance from the regulatory authorities.

Despite the challenges, there are some organizations that are making best use of social media while there are a few that got burned in the process. My interest in this subject is more from a technology perspective. What does this mean from an automation, integration and analysis stand point? As such organizations have recognized the need for safety data integration and analysis and started moving towards setting up safety data warehouses. The chatter on social media about adverse events from drug, device or vaccine use becomes another source to be scanned, filtered, reviewed and stored. Each of these activities pose a great challenge for technology implementation as well as effort required to setup the process and maintain it efficiently.

The key to successfully handling these challenges lies in finding answers to questions like:
1. Is our social media strategy in line with our organizational and regulatory policies?
2. What are the technology implications?
3. Is our IT team ready for this challenge?
4. Is the market mature enough to provide solutions and services to assist out IT and Business teams?
5. If not, which of the partners in our Ecosystem can help us develop the right solutions and provide services?

While these are some random thoughts and questions, it has to be seen how the market matures and rises to this challenge. The key is for the industry, as a whole, to figure out the use of social media in safety and Pharmacovigilance context and subsequently identify the right solutions that will provide the necessary support to make this a reality. As long as this doesn’t happen, the early movers will always be at a disadvantage and end up spending lot of effort and money while struggling to justify the return on this investment.

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