Why chosing open source solutions for pharmacovigilance?


I was recently asked what are the benefits of picking up open source technology over licensed pharmacovigilance softwares. Of course, I had arguments ready but I thought the topic itself deserves a more elaborate answer and that answer might be worth sharing to a broader audience. 

What I'll describe below in terms of advantage is for open source solutions deployed in house and not for open source SaaS solutions.


Open source solutions means that the code is open for review. That means that the details of the algorithms are plain for example or that the data transformation steps are visible to any code reviewer. 

Many licensed pharmacovigilance softwares hide the details of their deduplication strategy or algorithm of signal detection pretexting that it is their industrial secret. The lack of details makes it de facto hard to validate by the customers which can be problematic in a GxP environment.

Controlling the roadmap

Open source solutions can be further developed by the customers based on their needs provided they have the right expertise (in language/infrastructure) in house or through external support. 

Licensed pharmacovigilance softwares have their own roadmap based on a prioritization system that maximizes future revenues and not the needs of a specific customer. For example, a customer requests could be considered as not worth going to software roadmap as it could not be appealing for new/other customers.

Virtually unlimited number of users

Open source solutions do not come with licenses and if the infrastructure is scaled up appropriately it could support as many users as needed. 

Licensed pharmacovigilance software company usually make the customer pay per number of users per year, meaning that if there are extra users it comes with extra cost. Sometimes, customer companies have to restrict the access to some licensed pharmacovigilance software to stay within the agreed budget.

Limited cost

As discussed before there won't be license costs but there could be some extra costs related to the development of the open source solutions. Except if an already developed open source solution is bought which makes the customer control even more tightly the cost of the whole solution.

Increase in expertise

Interacting with open source pharmacovigilance solutions makes the users more expert in their field. Indeed, the ability to control the roadmap, the ability to upgrade the solution, the ability to screen the code makes the users more adamant to suggest new developments, to make informed decisions about the methods used, etc.