SafetyDrugs is the database that simplifies
your pharmacovigilance activities

With the safety database SafetyDrugs you can collect, manage, transmit and analyze ICSR(s) of adverse events from clinical studies and post-marketing surveillance, including literature cases, of all medicinal products: from drugs to medical devices, from vaccines to cosmetics.

The web-based application runs on Oracle database, our technological partner and leader in Relational Data Base Management System (RDBMS).

Developed in accordance with ICH E2B R3, compliant with GVP and GCP, it manages all EMA, MHRA and FDA requirements.


Safety database import/export ICSR
Import and export cases in R3 and R2 format

SafetyDrugs is developed to handle both. Through the appropriate tool, you can easily switch from one format to another.
Send ICSR(s) directly to the Regulatory Authority, to partners or colleagues, with the integrated message system or via the gateway. Monitor and keep track of all emails sent at any time.


Safety database SafetyDrugs storage
Keep your data in a secure database

SafetyDrugs is entirely based on Oracle technology, with which it offers data storage and access services on the cloud. Oracle data centers guarantee excellent security standards and the highest levels of quality. Furthermore, SafetyDrugs provides Disaster Recovery service on a secondary site to allow business continuity.


Safety database, analisi e report con SafetyDrugs
Generate all regulatory reports for pharmacovigilance analysis

CIOMS, Pregnancy form, PSUR (line listing, summary tabulation, work sharing), PBRER (cumulative Adr(s)), DSUR (line listing, summary tabulation), Standard MedDRA Queries (line listing, summary tabulation), MIR, MedWatch3500-A, Quality check report and other customizable listings for inspection purposes, reconciliation and monitoring of compliance.

Find out SafetyDrugs

Ask for a DEMO.
We will contact you back
to schedule a demo.

The presentation will last a couple of hours.
We will show you the main functionalities
and answer your question.

The tools for pharmacovigilance activities

SafetyDrugs, more info