Thanks to everyone on the great feedback we have received on this blog series focused on pharmacovigilance best practices for clinical and early post-approval biopharma companies. We've discussed discussed the importance of understanding reporting and submission to FDA, taking control of your pharmacovigilance software and creating a shared services model with your CRO.
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The idea of selecting, implementing, and deploying pharmacovigilance software is overwhelming for smaller companies. At larger pharma companies, teams of people, vendors, and consultants are dedicated to implement the software and keep it running. Smaller clinical and early post-approval stage biopharma companies have to make do with significantly fewer resources and they are understandably quick to look for outside help.
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Traditionally, safety related meta-analyses have been costly, taken significant time to produce and can often miss relevant studies. Further, there has been no efficient way to test the outcome of those studies prior to initiation. This has led to a lot of unnecessarily wasted resources.
Luckily, Advera Health with the help of machine learning, artificial intelligence, and data science is solving this problem for drug safety, epidemiology, and medical affairs departments of all sizes.
Last week we announced the launch of Clinical Meta-Analysis in Evidex capability and we have provided a walkthrough with screen shots is below. This new analytical tool provides the capability to perform meta-analyses of safety issues using a cloud-based software-as-a-service platform.
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It's been a busy week in the world of pharmacovigilance software. Major players are being acquired, new players are coming into the market, and there is more and more talk of the "next generation of PV" emerging.
First, this week it was the Wall Street Journal reporting that Nordic Capital has agreed to purchase a majority stake in ArisGlobal at a valuation of ~$700 million. On the heels of Medidata being acquired by Dassault Systemes, the WSJ opines that both deals are bets on the "...increasing adoption of software by the broader pharmaceutical industry".
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.
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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.
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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.
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