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.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
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.
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