fda1-1.jpgWow, it’s the end of February. I’m sure I’m not the only one who feels that the first two months of 2018 have flown by. Advera Health’s engineering, product, and analyst teams have been hard at work. Evidex’s back-end data architecture has been enhanced to keep up with our growing library of datasets and to ensure the analytics layered on all of the data are efficient and fast to meet client demands.

The front-end user interface continues to evolve as well, with a flurry of new releases in the past few months that add new statistical calculations such as EBGM and IC, the ability to analyze the details of individual clinical trials, and new modules to support Booz Allen’s Epidemico social media data and the Uppsala Monitoring Centre’s VigiBase global safety data.

Our very popular Evidex Alerts, which track safety related label changes, communications, and clinical trial results have also been upgraded based on all of the new functionality that we’ve rolled out. The alerts now feature custom analyses such as unique combinations of relevant MedDRA Preferred Terms (PT’s), Standardized MedDRA Queries (SMQ’s), as well as complex AND / OR searches with multiple drugs. This allows our analyst team to provide a deeper level of insight for our clients, while highlighting all of the different ways Evidex can drive value in pharmacovigilance processes.

On the commercial side of our business we have been very active as well. Along with our Chief Product Officer Bob Kyle, I attended the DIA Pharmacovigilance and Risk Management Strategies conference in January. Our management and product specialist team has been hard at work meeting with current and prospective clients, expanding our partnerships, and most importantly, gathering feedback on Evidex and market trends.

One interesting insight that has taken us by surprise is the general discontent by pharmaceutical pharmacovigilance departments with the turnaround speed and quality of the FDA Adverse Event Reporting System (FAERS) data they are receiving. We’ve advocated for years for FDA to speed up their release of the data files, but it isn’t the FDA’s delay that is causing the angst. The problem is the extended time their current vendors are taking to download, clean, standardize, and load those data into their software platforms. This is a process that should be core to high quality product experience and customer satisfaction.

At our company’s founding, our focus was on this very problem. Our mission was to make FAERS data more accessible through optimization and more actionable through a modern user interface and next generation analytics. Although the scope of our offering has grown to using multiple, disparate datasets for pharmacovigilance signal detection, validation, and evaluation, our commitment to fast, high quality FAERS data remains.

We proudly state on our web site that our turnaround time from FDA file posting to inclusion in Evidex is 7-10 days.

By stating that publicly we are setting up the expectation of accountability and a highly functional partnership with our clients.

Q4 2017 FAERS data is expected to be available soon, which creates the perfect opportunity to test our resolve. Sign up here to be alerted when the data are posted by FDA. Once the data is optimized and loaded into Evidex we’ll send you a screen shot of the top AEs for the drug of your choice.

Request FAERS Updates

If you have any questions on our process, Evidex, or anything else, feel free to contact me directly at jim (at) adverahealth.com.

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.