MedNova SafetyCore is our ICH E2B(R3)-compliant case management platform — the same system our pharmacovigilance team uses to run ICSR intake, aggregate reporting, and regulatory submissions for clients across Nigeria and West Africa, now available as a standalone platform for sponsors and Marketing Authorization Holders who want direct visibility into their own safety data.
Request a SafetyCore DemoA single system covering intake through submission — configured to reflect how your safety team already works.
Case intake, triage, and MedDRA / WHO-DD coding in one workflow.
Structured tools to draft and standardize case narratives.
Direct electronic submission to regulatory gateways in E2B(R3) format.
PSUR / PBRER / DSUR generation, built from your live case data.
Ongoing signal detection with a structured validation workflow.
Real-time visibility into case status and compliance tracking.
Reflects your existing safety governance rather than forcing a new one.
Built by the same team that runs your PV operations, so the platform and the people are already aligned rather than handed off between vendors.
Configured for African regulatory realities from the start, rather than adapted from a US/EU system after the fact.
Connected to MedNova's Regulatory Affairs and Clinical Development services, so safety data links directly to registration and trial-safety workflows instead of sitting in a separate silo.
From a fully managed service to a self-administered licensed instance for teams that want to run it in-house.
A walkthrough with MedNova's pharmacovigilance team, showing SafetyCore configured for your product types and markets.
MedNova sets up your tenant, migrates existing case data, and configures workflow rules, user roles, and submission gateways.
Your team goes live with training and documentation, backed by MedNova's existing QPPV retainer and support infrastructure.
Want the full picture first? See our Pharmacovigilance services instead.
Tell us who you are and what you need from your safety platform, and we’ll follow up with a demo time and next steps.