More and more pharmaceutical companies or providers of pharmacovigilance services are looking for a database that ensures compliance with the new ICH R3 regulations. In the evaluation phase, cost is a central element and in fact the most frequent question is: how much does SafetyDrugs cost?

There are many variables that affect the software economic impact in a company’s budget: a one-time start-up cost and a monthly fee.

1) Start-up

There are two types of contracts:

  • On-Premises, solution with installation at the client’s server
  • SaaS, Software as a Service, cloud solution with data centre installation.

In both cases the start-up includes:

  • Installation of test, production and eventual business intelligence environments on the server
  • Parameterization of the entire database
  • Configuration of the client on each location
  • Upload of MedDRA and WHO dictionaries
  • Supply of project technical documentation and results of functional tests.

Other items that contribute to the definition of the start-up cost:
Training. To acquire the concepts of database use, we recommend four days, two of which in the client’s offices and two via internet with a dedicated webinar.
Import of legacy data. The cost of import varies based on the quantity and quality of the data. It also depends on the original source: Excel sheet or database.
Support for validation. It is an optional service for an operational contribution in the functional testing phase in the customer’s environment.

2) Monthly fee

Big and small companies have different needs, the modularity of SafetyDrugs satisfies everyone. The architecture of the functions – and consequently the monthly fee – is mouldable on the various business realities.

The fee is the combination of three parameters:

  • Number of users. It means the quantity of physical users with personal access to the database. To comply with the regulations must be at least three, one for each phase of the case process: data entry, quality check and medical assessment. Two profiles can be configured for each user – administrator and operator – each with customized read and write privileges.
  • Number of sites. Quantity of separate and independent virtual spaces intended, for example, to branches or business units, to specific customers of a service company or to clinical studies of a Contract Research Organization (CRO).
  • Number of cases. The annual number of cases entered into the database determines an environment with more or less large memory space.
    Each of the parameters and the resulting fee can be reconsidered as needs change.

The basic module manages the entire pharmacovigilance cycle for drugs and clinical studies. Includes the Selective Import function for the massive acquisition of HL7 files with a relative triage mask prior to import.

Among the optional modules there are:

  • Devices with MedDev and MedWatch reports
  • Cosmetics
  • Vaccines
  • HL7-XML and XML-HL7 converters
  • Business Intelligence

The fee also includes the license to use the database, disaster recovery, maintenance assistance and all updates.


To determine the costs of configuring the safety database that best adheres to company quality processes, it is necessary to weigh each variable and balance the best cost/benefit ratio.
In Max Application, the developer company of SafetyDrugs, there is a person responsible for evaluating the ideal configuration model for the individual client. You can request a custom quotation by filling out the form below.