Max Application develops solutions for the pharmaceutical world and, in particular, manages the pharmacovigilance processes thanks to SafetyDrugs, its safety database.
SafetyDrugs supports the capture, management, reporting and analysis of adverse events from clinical trials and from post marketing surveillance, including cases from literature, of all medical products: from drugs to devices, from vaccines to cosmetics. SafetyDrugs 6 is compliant with ICSR ICH E2B (R3), EMA and FDA rules. It is available both On Premises and in SaaS modality on Oracle® Cloud Platform with disaster recovery protection.
The Signal Detection analysis is included in the Business Intelligence module and provides statistics that show the evidence of adverse events with disproportionally high statistical scores.
With SDConverter tool, SafetyDrugs is able to directly import the ADR(s) from PDF file provided by Italian National Authority "Rete Nazionale di FarmacoVigilanza”.
Max Application provides direct assistance through its internal assistance team.