Life Sciences

How Argus Safety Enables Faster Case Management Times

The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and pharmacovigilance system that Perficient has been implementing for sponsors and CROs over the years, my colleagues and I will showcase some of its features (focused on users and administrators) in a handful of upcoming posts.

Oracle-Argus-Safety-Case-Entry

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As we all know, being able to perform case management activities quickly is ideal. One way Oracle has managed to enable faster case management times is through the Argus Safety user interface. The tabs and fields are kept to a minimum, and they are structured and organized in a way to make case entry efficient and familiar to those with a more clinical mindset.

The screenshot above shows the Case Entry sub-system in Argus Safety. You’ll notice that the design is fairly intuitive, doesn’t duplicate information, follows a typical electronic medical record entry style, and thus eliminates some typical entry confusion found in other systems.

Check back soon to see our next Argus Safety feature-focused post on event and product assessments. To read past posts in our Argus Safety features series, click here.

References:

FDA. (2014). FDA issues final rule on postmarketing safety report in electronic format.  Retrieved on November 24, 2014 from http://www.fda.gov/Drugs/DrugSafety/ucm400526.htm

About the Author

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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