Case processing AI is turning on the human pharmacovigilantes!July 11, 2029 Wednesday - 9:01 AM. The Tech-Com Human Resistance succeeds in destroying Skynet's defensive grid located in Colorado, USA. The Skynet mainframe is breached by Resistance soldiers, and Skynet is deactivated, finally ending the War of the Machines and returning domain of planet Earth to humankind.

Perhaps, because I grew up on Terminator movies, the year 2020 feels like the future to me. It was 2029 when Skynet collapsed and here we are only nine short years away! Using Terminator math, the case processing AI is already turning on the human pharmacovigilantes and throwing the world of drug safety into a fight for its very existence!

Luckily for all of us, the War of the PV Machines is the stuff of science fiction.  However, the conflict, or more specifically the friction that exists within pharmacovigilance is at the top of our minds here at Advera Health.

In our end-of-the-year planning meetings we reflected on our experiences since the company launched and came to the conclusion that any setbacks we’d experienced had been the result of the inherent friction that exists in the pharmacovigilance domain. Not surprisingly then, all of our successes have stemmed from when where we have been eliminated that friction.

Our lofty goals for the coming decade are to use our technology and innovation to further reduce friction in pharmacovigilance.  

We will focus on three key areas:


#1 - Balancing the market’s need (and desire) to evolve with day-to-day workloads in a regulated environment.

Ask any pharmacovigilance professional if they are interested in doing more to support their organization and the answer is, “Yes, if only I had the time”. In a regulated environment, there are many requirements that need to be fulfilled, documented, and enacted. Not only do you have to do the work (with tools that are either complicated and time consuming, not fit-for-purpose, or both), you have to document how you plan to do it, and then exactly how you actually did it. Not to mention the sea of interconnected documents that need to be updated if something changes! All of this leaves drug safety leaders between a rock and hard place; How can they evolve when they simply don’t have the time?

Our goal is to continue to create efficiencies through technology that help to reduce the workload and enable PV leaders to establish best practices early in an organization’s life cycle. We eliminate the evolution vs. workload friction inherent in pharmacovigilance through best-in-class user experience in Evidex and hassle-free implementations.


#2 - Aligning PV business users and IT departments.

Software is eating the world… and now it is finally eating pharmacovigilance. The consumerization of enterprise software is becoming prolific and business users are driving decisions that have previously been the sole domain of IT. Legacy vendors that have traditionally been “Enterprise IT friendly” are no longer the first choice. In the near term this creates a tug-of-war between business and IT that needs to be negotiated. The standoff creates long, friction-fueled buying cycles that many times end in a stalemate. Nobody wins.

Our goal is to continue to make pharmacovigilance software that end users actually want to use while ensuring that our Evidex platform meets the goals of IT. Nimble organizations like Advera are ideally equipped to create the partnerships that can bridge the gap between business and IT and eliminate this friction.


#3 - Enabling Drug Safety to be a revenue driver rather than simply a cost-center

Despite many advances, pharmacovigilance is still seen as a cost center, not fully understood by executives, and forced to fight for budget. For anyone that has doubts, take a look at this post on LinkedIn about one pharmacovigilance professional’s “PV Wish List”. Most of the discussion and comments supported #5 on her list- I wish Pharma (in general) had a higher respect & understanding for PV.

How can PV leaders contribute if they aren’t empowered to do so?

It is our goal to empower pharmacovigilance professionals with the right data, analytics, and software to make their jobs easier, align business needs with those of IT, and create an environment that enables drug safety to be commercially aligned business unit.

There is a lot of work to be done before 2029 comes to a close. And while Advera may not deactivate Skynet or end the War of Machines, we believe we have the right technology, people, and customer partners to help end the conflict that is holding pharmacovigilance back.

Topics: Pharmacovigilance Software

Jim Davis

Written by Jim Davis

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