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.

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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.

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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.

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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.

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December 26, 2018

Top 5 Blog Posts in 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.

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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! 

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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.

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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.

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November 2, 2018

Signal Prioritization and Assessment in GVP Module IX for Signal Management

After an initial review, a determination is made whether the signal is non-validated or that it is in fact a validated signal that needs prioritization and further assessment.

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October 19, 2018

Signal Validation in GVP Module IX for Signal Management

Signal validation is the process of confirming a new potentially causal association, or a new aspect of a known association, of a drug-event combination. When validating a signal, GVP IX recommends that the following elements should be considered:

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