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.
In addition to "simply" replicating meta-analysis studies, signal detection, validation, and assessment procedures become more efficient by combining the outputs with data from spontaneous reporting databases like the FDA Adverse Event Reporting System (FAERS), the Uppsala Monitoring Centre's VigiBase, or a client's internal global safety database in a single platform. This further frees up time and resources for insight driven pharmacovigilance analytics.
In order to showcase the capabilities, let's walk through as simple example of finding a benchmark rate... READ MORE.
Not only is the blog post in the top 5, but our Clinical Meta-Analysis tool is one of our clients' most-used new features that we launched in 2019. I've yet to see anything else like this in the market.
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.
For certain aspects of pharmacovigilance, outsourcing makes sense. Outside technology consultants and CROs play a vital role in helping an organization grow. But when it comes to access to vital data, the division of labor, and the ability to maintain proper oversight on drug safety operations, even smaller biopharma companies need to consider “in-sourcing”.
The following best practices will help to understand regulatory requirements, what elements should be kept in house, and how to best work with CROs.
Best Practice #1: Understand what is reportable and know how reports are submitted to FDA.
The simplicity that software brings to pharmacovigilance creates a shared services model that empowers the sponsor to maintain proper oversight of drug safety while enabling the CRO to implement the same model at scale. Next generation, cloud-based SaaS signal management platforms exist to manage both clinical and post-marketing safety case reports in a GVP IX compliant way that can fit into any budget, in any size company.
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:
AI is hard. AI in a regulated environment is harder. READ MORE.
Real-world data (RWD) for pharmacovigilance is coming of age. READ MORE
Stakeholders are ready for new pharmacovigilance software. READ MORE.
The market for pharmacovigilance software is evolving quickly. What the 2019 DIA-PVRMS conference proved to me was that industry leaders are more willing than ever to look past legacy systems and focus resources on building a system of intelligence that will drive pharmacovigilance workflow for years to come. Can't wait to see what the 2020 DIA-PVRMS meeting has in store for us!
Since Salesforce ushered in the age of software-as-a-service (SaaS) 19 years ago, the market for software has changed dramatically, as have the products that companies have brought to market.
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? READ MORE.
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. We saw a lot of gains in 2019 in this regard, but are very excited to see what 2020 will bring!
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.
The popularity of this post shows that we as an industry are champing at the bit to see our historically stodgy drug safety world shaken up. Will we see any material changes in 2020?