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.Read More
We work with biopharma companies across the size spectrum. When small and medium sized companies with marketed products first approach us, many of them have not implemented a software solution for signal management. Why? Many feel their case volumes are not high enough. Others believe they don’t have the right in-house resources. Still others have “a great spreadsheet that works just fine”. All of these excuses, err, reasons boil down to one thing: FEAR.Read More
We founded Advera with the goal of designing a pharmacovigilance platform that provided a modern user interface and next generation data and analytics. The FDA Adverse Event Reporting System (FAERS) was the first dataset we integrated into our Evidex platform. In those early days, we strived to create an optimal FAERS experience, which meant finding a way to quickly ingest, standardize, and de-duplicate the very messy raw FAERS data.Read More
Every year I use the DIA Pharmacovigilance and Risk Management Strategies Conference (DIA-PVRMS) as a barometer to help better understand where the pharmacovigilance and drug safety industry is at and where it is heading in the coming year.
Now that the 2019 session is behind us, I thought I’d summarize my thoughts.Read More
I recently wrote an article for PharmExec called Pharmacovigilance Software is Having its “Salesforce” Moment. It discusses how the market for pharmacovigilance software is starting to catch up to other verticals through disruption by technological innovation. I argue that the barriers that were in place such as drug safety’s role as a cost center and the difficulty of accessing data are breaking down. And the result is that there are now choices in the pharmacovigilance software market that weren’t available just a few years ago.
After re-reading the article, I think there is an important, key point that got lost and could use further definition. The concept of the evolution of software from a “system of record”, to a “system of engagement”, to a “system of intelligence”, and why that evolution is so important.Read More