Following the introduction of the new pharmacovigilance rules, more and more pharmaceutical companies are deciding to replace their old safety database with a native ICH R3 one. Whether it comes from an Excel spreadsheet or a software, the change always raises numerous questions. So we wanted to explain what to expect during the analysis of the new product.

Preliminary analysis

It is the first phase in which, after the initial contact, a teleconference is usually organized and the companies introduce each other. Max Application, the developer company of SafetyDrugs analyzes the contractual aspects related to the two types of service provided: SaaS or purchase. In the first case, the cloud structure and the location of the primary and disaster recovery datacentres are detailed and the questions concerning privacy and validation are clarified.


The second part of the teleconference is dedicated to the demo in order to show the main functionalities of the database. Not only those ones strictly related to the process of the case, but also those useful for comprehensive management of the pharmacovigilance activity: the To-do list helps to plan the activities of each team member, the Alert system sends internal messages and reminders, and the Tracking tool keeps track of follow-up requests, just to quote some examples.


Depending on the kind of customer, in addition to the basic module which manages ICSR from drug, both post-marketing and clinical trials, also the optional modules for the management of cases from devices, vaccines and cosmetics are presented. They can be added to the main database at any time.


In the presence of a company that manages a fairly high number of cases, it is also useful to consider the Business Intelligence module, which, through flexible tools and intuitive dashboards, allows to carry out in-depth analyses, including the signal detection.


Another topic normally dealt with is that one concerning the migration of cases contained in the old database to SafetyDrugs 6. Depending on the type of original R2 database, Excel or other software, the import modality to be adopted is discussed.


Then, the Quick Start Validation Kit is illustrated. It is a set of validation documents that Max Application provides to all customers.


To conclude the preliminary analysis a tailor-made commercial offer based on the needs that emerged during the teleconference is sent. Following the agreement between the parties, the official Contract will be drafted.