Signal management is one of the most audited pharmacovigilance processes. It also generates one of the highest findings from audits. The ability of Marketing Authorisation Holders (MAHs) to make a robust signal management system that is fully audit/inspection ready sometimes falls short of expectations. Happily, technology can be used to make the process more scientific and rigorous.
Technology in the signal management process can be divided into two categories. The first one is the front end i.e. what platform (.Net/JAVA) is being used to develop the system. The second is the back end i.e. what programs/software (R, Python, SAS) are used to process the data. In this blog, we will focus on the second category and discuss how R specifically can help improve the signal management process.
Dec 12, 2017 7:33:00 AM