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Software market for pharmacovigilance automation can be divided into global large players, medium-sized companies and small local solutions. Flex Databases conducted an in-depth study of market participants based on 60 parameters.


Let's consider the main distinctive features of PV solutions.

Large global companies are well-known to everyone – for instance, Oracle and, in our opinion, the most successful and most innovative competitor to Oracle – ArisGlobal.


What’s offered by global suppliers - market leaders? They will be distinguished by:

  • Reliability at high loads - thousands of cases.
  • The most advanced features, for example, social networks search, mobile application.
  • A very high price, only installation will cost from 40 000 to 150 000 € depending on the company, and then 20 000 - 70 000 € annual fees. A lot of additional payments.
  • The need for IT support / competence within the company-owner of the registration certificate.


Medium-sized, more modest vendors:

  • They have a necessary minimum of functionality, e.g., they could be lacking such functions as autocoding and duplicate search. Ennov company is a good example. At the same time, the necessary set of functions for entering, processing and reporting cases is always there.
  • They meet the requirements of international regulations, just like the global players.
  • The cost is already more tolerant and makes more sense with smaller amounts of cases than thousands per year. From 5 000 to 10 000 € for installation and setup, then 1 000 - 5 000 € monthly.


Small young vendors:

  • As a rule, international regulations are neglected due to the simplicity of functionality.
  • If you look closely, it becomes clear that the system is an ordinary tracker, not much different from Excel.
  • Absence of key functions: MedDRA browser, urgent reports, user notifications, search for duplicate cases, search (grouping, filtering) in the event grid.
  • About localization. It’s more likely to be there, as young vendors will be oriented to the domestic market at first, and then will move to the international market. At some level it gives them the opportunity to neglect certain regulations. A great example is the fields for collecting information not based on ICH.
  • About the cost of such solutions. Here the situation will strongly depend on the stage of product development. Of course, if a solution is not already in use by a number of famous companies, and they need to develop a client base and recommendations, the cost of such solutions can be very appealing. It should be clear that it will grow over time, and it is especially reasonable to approach the question of whether the registration certificate owner is ready to hold an experiment on the introduction of a system that is not popular on the market and has not been verified by time. As a result, insignificant savings in implementation of a new solution, rather than a solution from the middle segment, can result in large resource and reputation losses.


Flex Databases pharmacovigilance module is a unique solution that includes the deep functionality of global suppliers level at a reasonable cost and ease of use of medium-sized suppliers.

You can find out more about Flex Databases Pharmacovigilance system here or contact us for a demo.

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