New codes of practice and guidelines in the EU and US hold marketing authorization holders (MAH) to higher standards for the surveillance of adverse event (AE) and product quality complaint (PQC) data. While good pharmacovigilance (PV) and safety surveillance is a required practice, companies agree that having more and better insight into their data can provide a higher return on investment from their studies and products.
The challenge with all PV and safety surveillance, as we all know, is that it’s quite complicated. There’s a lot of data, and there are few technical solutions that make analyzing safety data simple.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
For this reason, our PV experts developed a system that addresses the industry’s needs and requirements. That’s also where our upcoming webinar comes into play.
Join Perficient’s Kari Blaho-Owens, Ph.D., Director of Pharmacovigilance and Safety, on February 6th, 2020 at 10-11 AM CT, for a demonstration of PV Hawk, a risk management tool that gives you quick access to aggregate data for the meaningful analysis of AE and PQC data — all in real time and across all of your safety surveillance practices and interested parties.
The system renders easy-to-use outputs that are intuitive for surveying your data for potential trends without spending time running complex database queries or chasing false positives.
During the webinar, you’ll learn how PV Hawk enables you to:
- Analyze AE data with drill-down capabilities and graphic representations that are easy to interpret
- Overlay company data with data from FDA AERS for trends and risk/benefit analysis
- Compare same-in-class drugs or drugs used for similar indications
- Analyze the impact of drug-drug and drug-disease interactions
If you are interested in learning more about real-time pharmacovigilance surveillance and our new software solution, please register for our upcoming webinar.