The RxView Blog

August 1, 2019

How to Replicate a Clinical Meta-Analysis Study in Evidex

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.

June 20, 2019

Busy News Week for Pharmacovigilance Software

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".

June 13, 2019

Why Has Pharmacovigilance Software Lagged Behind Other Industries?

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.

May 23, 2019

When is the Right Time to implement Signal Management Software for Pharmacovigilance?

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.

May 16, 2019

FAERS Data Optimization & Deduplication in Evidex Gets Even Faster

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.

February 8, 2019

3 Thoughts on the 2019 DIA-PVRMS Conference

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.

December 26, 2018

#5: 2018- The Year of Next Gen Drug Safety and Pharmacovigilance 2.0

Overview:

We have a tradition in the RxView blog of starting each new year by asking if the year ahead will be “The Year of Drug Safety” or “The Year of Healthcare Technology”. We typically lay out a few thoughts on why the year ahead has the potential to be a big year.

November 30, 2018

Videos - The Evolution of Pharmacovigilance Software

We recently created two video's that help to explain the evolution of pharmacovigilance software and the value this evolution creates for an organization. See our Pharmacovigilance Software Overview for more information or schedule a personal demo of Evidex!

November 23, 2018

The Evolution of Pharmacovigilance Software

I recently wrote an article for PharmExec called Pharmacovigilance Software is Having its “Salesforce” Moment. It discusses how the market for pharmacovigilance software is starting to catch up to other verticals through disruption by technological innovation. I argue that the barriers that were in place such as drug safety’s role as a cost center and the difficulty of accessing data are breaking down. And the result is that there are now choices in the pharmacovigilance software market that weren’t available just a few years ago.

After re-reading the article, I think there is an important, key point that got lost and could use further definition. The concept of the evolution of software from a “system of record”, to a “system of engagement”, to a “system of intelligence”, and why that evolution is so important.

November 16, 2018

Quality Requirements in GVP Module IX for Signal Management

Over the course of the last blog posts, the requirements of the four stages of the GVP Module IX Signal Management (GVP IX) process were discussed in great detail, along with specific ways in which Evidex Signal Management can help an organization to efficiently meet GVP IX requirements in a single, user-friendly, easy to implement platform built on a foundation of safety data and analytics.