Life Sciences

Improving Pharmacovigilance Surveillance With Real-Time Tools

pharmacovigilance

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.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

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.

Get the Guide

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.

About the Author

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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