The SaaS model has become so commonplace that even Salesforce itself had to clarify back in 2015 that “No Software” really meant, “No legacy software, just cloud software.” SaaS and software are now synonymous, in all but a few cases. Pharmacovigilance software is one of those few cases. While the software itself is no longer shipped via a CD-ROM, and it’s been well documented that the major players like Oracle are making its shift to the cloud, existing on-premise installations still dominate the market and even new cloud-based options are still just remote servers, with similar software installation.
Why has pharmacovigilance software lagged behind?
First and foremost, the world of pharmacovigilance is one of extensive regulations that up until recently have seemed to be always changing. A significant repository of standard operating procedures and required process documentation paperwork is necessary to pass any regulatory inquiry or audit. Both IT and business have had to focus on making sure what was in place was compliant.
Second, pharmacovigilance has historically been seen as a cost center within an organization, existing solely to fulfill the obligations that were required of them. Thus, a legacy system of record was all that was seen as necessary. Enough to capture ICSRs, do the minimally required aggregate signal detection to be included in periodic reports, and record actions taken in the process of managing that signal.
Very recently however, a shift has begun to occur. The last of the Good Pharmacovigilance Practices (GVP) requirements have gone into effect. Big data has gone mainstream. And forced by demands by their customers, pharmaceutical companies are being asked to generate insight as it pertains to safety.
The last point is, in my view, the most important. In order to generate insight, appropriate tools need to be in place that are accessible to more than just a select few power users, in a select few resource capable companies. Data mining in 2019 should not require the end-user to be a data scientist.
At Advera Health we are focused on easy-to-use data and analytics. We believe that by empowering end-users at all levels of pharmacovigilance to take advantage of disparate data sources through a modern user experience, we can help advance the science of pharmacovigilance at a rapid pace.
Want to learn more? See our "no download necessary" white paper, Pharmacovigilance Software in 2019.