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.

Fear of change. Fear of making the wrong decision. And fear of how change and making the wrong decision may impact the company and the decision makers' careers.

This fear is well founded. Legacy vendors have over-complicated signal detection and management software.  They've enabled and encouraged a closed-loop ecosystem of “gold partner” consultants, integrators, and specialists that earn good money to keep things complicated. With year-long implementations, costly maintenance and upgrades, and underwhelming usability, it’s no wonder why so many companies delay the decision processes around the implementation of signal detection software for as long as possible.

To all of those struggling with these timing questions, I say the right time is now and the timing has never been better.

There are new options available that can scale as you scale, don’t require outlandish maintenance or professional services contracts, and still outperform with enterprise caliber functionality.  

At Advera Health our goal is to create a signal management system that is agile, flexible, and can serve both the largest of pharma and the smallest of biotech. Our technology is built around the concept of connecting disparate data sources and providing user experiences that allow even non-data scientists to elicit actionable intelligence from safety.  We're not just looking to help you fulfill regulatory duties, we want to give you the tools you need to be of greater service to your entire organization.

As you can see in the video below, we’ve built our Evidex platform to link internal ICSR databases, FAERS, VigiBase, and other real-word data within a validated, audit-ready environment so you can properly track and manage safety issues.

What comes next?  Simple - we will continue to innovate and refine the system of intelligence that supports the next generation of pharmacovigilance.

Topics: Pharmacovigiance 2.0, Signal Management, Pharmacovigilance Software

Jim Davis

Written by Jim Davis

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