Jim Davis

Jim Davis

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

Recent Posts

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.

Read More
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.

Read More
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! 

Read More
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.

Read More
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.

Read More
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.

Read More
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:

Read More
October 5, 2018

The Signal Detection Process in GVP Module IX for Signal Management

Advera Health has long embraced the fact that safety signals can arise from a wide variety of data sources. The authors of GVP IX agree. The module specifies that common datasets include spontaneous reporting (MAH’s own database, national databases such as FDA Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase), active surveillance, studies, and scientific literature. All of these data sources should be considered depending on characteristics of the product and based on clinical judgement.

Read More
September 21, 2018

An Introduction to GVP Module IX for Signal Management

Good Pharmacovigilance Practices (GVP) are a set of measures put into practice in 2012 to facilitate the performance of pharmacovigilance in the European Union (EU). GVP is broken out into several modules that govern different aspects of pharmacovigilance processes. GVP Module IX - Signal Management (GVP IX) provides general guidance and requirements on scientific and quality aspects of signal management.

The guidelines apply to Marketing Authorization Holders (MAH) for medicines authorized by the European Medicines Agency (EMA) and EU Member States. However, in the absence of formal regulation on the process of signal management by other health authorities, such as FDA, these guidelines have become the de facto global standard.

There are several aspects of the GVP IX process:

Read More
August 10, 2018

Are Social Media Data used in Pharmacovigilance Biased?

In addition to asking questions around the value and validity of using social media monitoring for pharmacovigilance, we also often get questions around our thoughts on whether social media data are inherently biased. When I brought this question to the Booz Allen Epidemico data team, they educated me on the three dimensions of bias that come from different drug safety datasets: Patient reported outcomes, seriousness, and completeness. The graphic below shows how those three dimensions differ across social media, clinical trials, spontaneous reports, and EHR records.

Read More