Tag Archive | Aggregate Reporting

Transition to Oracle Argus Safety – Key Considerations – Part 2

In my previous post titled “Transition to Oracle Argus Safety – Key Considerations – Part 1” I summarized the key considerations for Transition to Oracle Argus Safety. The Infographic included in the previous post, summarizes the considerations across the Business Process, Business Support and Application Support areas.

In this post, I will outline the considerations in Single Case Handling. This is one of the most resource intensive and critical functions of a safety organization. This is one function that cannot be interrupted, despite transition to a new tool/system, as it his many implications on the sponsor organization as well as on the patients.

  • Business Process Services:
    • Process Optimization: This is one of the aspects of the safety organization that will be impacted immediately. The business teams processing the cases would have reached their peak performance within the current environment.       Introducing Argus will impact the team as they have to learn new tool and also readjust to a process that most likely was reengineered
    • Case Receipt Automation: Many organizations would have automated the Case Intake process. The process of automation and any tools associated with it would have to be reengineered to leverage Argus’ Intake capabilities instead
    • QA, Metrics & Best Practices: The quality assurance of the single case processing, the performance metrics associated with it and the best practices established over the course of time will all be impacted and probably take a dip with the introduction of Argus. This has to do more with the change in itself rather than the functions/features/capabilities       of Argus tool
  • Business Support:
    • Access Management: The users need to be configured in the new system. Also, if any new users are being on boarded as part of consolidation then this will have to be accounted part as part of access management
    • Partner Support: The Safety organization will have established relationships with CRO partners. These partners need to be supported during the transition. This might also mean reengineering some of the Intake processes, tools and systems. If Argus Affiliate module is being leveraged for capturing AEs from the affiliates, this could add additional entity to the support organization from a configuration as well as help desk support perspective.
    • Report Distribution: The established channels of distribution of expedited reports to regulators will be impacted with the introduction of Argus. This might mean retesting any electronic E2B report submission channels. The review, approval and submission of reports may need to be configured using Argus and Argus Interchange modules.
  • Application Support:
    • Workflow Configuration: The Case Processing workflow need to be reconfigured. For large organizations this is usually a complex task as the automated routing of cases to the right groups/personnel is key to efficient processing. If a global consolidation is undertaken as part of the transition, this task would become even more complex.
    • E2B and Reconciliation: The established process and tools for collection and/or distribution of safety data/reports to/from partners should be reengineered with the inroduction of Argus. Also, the safety case reconsiliation that happens between the clinical and safety systems will be impacted and should be reengineered and automated to account for changes due to Argus
    • Distribution:  As mentioned in the Business Support, the reporting process will be reconfigured, which will necessitate a reengineering of distribution process.

In the next part, we will look at additional considerations from an Aggregate Reporting perspective.

Social Media, Literature Search, Sponsor Websites – A Safety Source Data Integration Approach

I haven been part of my fair share of discussions on Drug Safety and Social Media. In fact, I have even written a blog post about how these two are being forced into an “arranged marriage”, which could be a good thing :-). While processing data from social media is very complex and often unreliable, there is increased push to process it anyway. Understandably, Marketing teams are the first to adopt social media channels in pharmaceutical organizations, now the drug safety teams are being forced to act as these channels could end up generating adverse events and they are obligated to register, review and report.

As mentioned, processing of data from social media could be complex and may yield very few cases (0.2% according to a Nielsen’s Online survey of health-related social media content) the high level process is very similar to Literature Scanning. The later is something that is already being handled by organizations. I think that the Social Media content search and analysis can becoming an extension to this process. Now lets look at both the processes.

Literature Search:

Literature Search is used by BioPharmaceutical organizations to identify Adverse Events related to their medicinal products in medical and scientific journals published worldwide. This process was adopted as a result of multiple serious adverse events and the ensuing regulations and increased safety concerns. Many sponsor organizations have successfully built automated systems to speed up the overall process. These systems typically scan sources (Journals, Abstract Libraries and Reference Libraries) based on certain keywords, product names, Boolean expressions etc. and capture the mentions into a local database. These entries are then screened by trained professionals to either accept or reject them based on the required data elements to qualify as an adverse event. If additional details are required, the journals are purchased and reviewed to qualify the “hit” as an adverse event. Once identified, this becomes a case that will then be transferred manually or electronically (e.g. E2B) to an Adverse Event Management System and will follow the life cycle till it is reported as an expedited or periodic report to regulatory authorities.

Social Media:

This process can be very similar to Literature Search except that the source of data is much more diverse and also the data is far less structured. Depending on the source system, a manual or automated process can be adopted to monitor and record the “hits”. If the source system is a “blog” or “Twitter” or “Facebook”, a tool can be build to continuously poll certain blogs, tweets or Facebook pages to scan for keywords, products/brands etc. The resulting “hits” can be processed to filter and aggregate the “trends”. These trends can then be reviewed by trained professionals to make a decision on whether they qualify as “Safety Cases” that will then be processed per the AE case management process.

Enterprise Websites, Response Centers etc.:

The third variety that may be considered as source systems for safety cases are Brand Websites and other portals setup to increase the brand awareness or assist the patients to receive medicine faster or address any questions and concerns. This may even include response centers setup for patients, pharmacists and physicians to reach the sponsors for information and advice. Depending on the nature of inquiries, these could be potential sources of Adverse Events. This data, once screened and qualified, can also be fed into the AE Management System for subsequent review and reporting purposes.

Source Data Integration:

From a technology standpoint the architecture and design for aggregation and analysis of data may differ for each of the datasets. However, an integrated approach to collecting, aggregating, analyzing and reporting of Adverse Event data needs to adopted by the sponsor IT organizations. The diagram below depicts:

  1. Multiple Source Categories and Systems (Literature, Social Media, Enterprise Websites)
  2. Multiple Interfaces  (Manual, XML, Text, API, RSS, Web Services etc.)
  3. Simple, High Level process to screen, record, review and report the case
Literature Scanning, Social Media & Enterprise Websites  - Safety Source Data Integration

Social Media Safety Source Data Integration

(To Be Continued…)

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