PharmaVOICE Blog Post

Automating Safety Case Processing: The Options

Posted By: Dan Limbach
August 10, 2020

With more companies responding to growing caseloads by using automation to streamline elements of the pharmacovigilance/multivigilance process, it’s useful for safety professionals to understand the different options available, as well as how automation today can eventually allow the development of “touchless” case processing.

We’ve written an e-book that provides a comprehensive overview of automation in case processing. This blog post and its two companions offer brief summaries of the key sections of this e-book, which you can download for free.

Before starting implementation, it’s helpful to review the three main types of automation safety teams can use. Each of these has attributes that make it best-suited to particular aspects of case processing, from handling repetitive and static tasks all the way to analyzing large volumes of data from diverse sources to identify potential safety issues.

Two of these approaches are well-suited to reducing the resources allocated to time-consuming parts of safety case processing; the third, AI, has additional uses and we’ll look at that in the next blog post.

The first approach is rule-based automation (RBA), which uses fixed algorithms to allow computers to relieve people of routine tasks, ones where human judgement or specialized expertise isn’t required (for example, steps like narrative generation or archiving). Rule-based systems are already in widespread use at many companies, because they are fairly straightforward to implement and because they are, optimally, built into the case management system, e.g. Argus.

The second, related, approach is robotic process automation (RPA), in which companies program a third-party “bot” to perform those repetitive tasks. This approach is typically used when the underlying case management system lacks built-in RBA capabilities. Because RPA is “bolted on”, it may require additional licensing and validation that make its implementation more complicated.

To learn more about RBA and RPA, as well as the use of AI in case automation, download this new e-book THE NEXT DOMINO: Automation, AI, and touchless safety case processing.

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About the Blog Poster: Dan Limbach

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