SafetyDrugs is a pharmacovigilance software that manages the adverse events from clinical trials and post-marketing surveillance related to drugs, vaccines, medical devices, cosmetics and food supplements.
The database manages the whole pharmacovigilance process: uploading, managing, reporting and analysis of adverse events.
It is powered by Oracle database.
It is compliant to EMA and FDA regulatory requirements and is aligned to the new rules ICH ICSR (R3).
Moreover, SafetyDrugs is supplemented by a Business Intelligence module, that extracts data from the database and allows to produce various situations: the Signal Detection, quantitative and qualitative Period Analysis, analysis of cases related to sales and customizable Line Listing .
Your company will be able to start working with SafetyDrugs in few days, thanks to its user-friendliness and to the standard parameterization provided.
In case you choose the Software as a Service (SaaS) model, the data and the programs are hosted in a Oracle Cloud platform based in Amsterdam, where the test and the production environment are already customized and configured.
After a quick training you are ready to insert your first case!