SafetyDrugs, the safety database.
Solid. Sturdy. Secure.
Solid. Sturdy. Secure.
SafetyDrugs is the pharmacovigilance software that allows you to collect, manage, transmit and analyze adverse events from clinical studies
and post marketing surveillance, including literature cases, of all products: from drugs to medical devices, from vaccines to cosmetics.
The web-based application runs on Oracle database, our technology partner and leader in Relational Data Base Management System (RDBMS).
What is it?
SafetyDrugs is the safety database that simplifies your pharmacovigilance activities: suitable for collecting, managing, transmitting and analyzing all adverse events.
Why?
SafetyDrugs is more than a simple database:
it is the tool that helps your work and its management. Supplied with features and tools for you and your team.
How much?
SafetyDrugs is profitable for everyone:
it suits any reality, saving unnecessary costs. Build your database fitted to
real business needs.
Last news
Personal data in ICSRs: compliance is a matter of system architecture
Managing personal data in ICSRs requires structured control of regulatory data flows. GDPR and GVP Module VI Addendum II make masking and data minimisation a system architecture issue.
EMA HTTP schema disabling: how to prevent issues in ICSR submissions
Disabling HTTP for EMA XML schemas impacts ICSR submission via Gateway and EVWEB. Here are the deadlines, technical impact, and compliance requirements.
Proposed amendment to the MDR: what changes for vigilance and surveillance
Technical analysis of the proposed MDR and IVDR amendment: what changes for vigilance, PMS, PSUR, cybersecurity, Eudamed and EMA.

























































