Oracle Argus Safety 8.1.1 was officially released today, so I thought I would share a question that came up recently from a hosting customer. The customer asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that companies should understand.
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.
All companies that currently report safety data to regulatory agencies or partners using E2B will be required to adopt the new E2B(R3) format beginning in 2019. If you will be receiving cases from the European Medicines Agency (EMA) via the new EudraVigilance website, you will only be able to download these reports in R3 format. If you don’t upgrade to 8.1.1, you will need to use a backwards and forwards conversion (BFC) tool, which can transform the R3 file into an R2 file that you will then be able to import into Argus.
The Uppsala Monitoring Centre (UMC) will be releasing WHODrug B3/C3, the new version of the dictionary, which will increase the length of two fields: CMCLAS and CMDECOD. This will help future-proof the dictionary. According to the UMC, the new version will be available alongside the current B2/C2 version until September 2018, at which point the new version will be the only option. While you will be able to load the new dictionaries into 8.1.1, Oracle said it will not be creating a patch for older versions.
If you are interested in upgrading to Argus Safety 8.1.1 and/or exploring our cloud hosting capabilities, I’d be happy to speak to you about it. Feel free to send me an email at firstname.lastname@example.org.