When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application.
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.
The four basic kinds of periodic reports in Argus Safety share a very similar configuration interface that allow you to perform the following tasks:
- Set general information on the report
- Select the product being reported
- Select the cases required for inclusion in the period
- Identify AE of special interests
- Include user-defined line listings/tabulations
- Identify or manipulate the required summary tabulations
- Establish security
In prior versions of Argus Safety (pre-7.0.2), periodic reports were submitted directly from the system, although it often caused performance issues while waiting for large periodic reports to complete. Post-7.0.2, periodic reports are submitted in the background, on the report server, thus mitigating the performance problems previously experienced. One of the benefits of the newer versions of Argus Safety is that there are no system performance issues when generating and submitting very large reports.
To read past posts in our Argus Safety features series, click here.