Enterprise-grade drug safety, built for African regulatory realities.
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.
Core capabilities
A single system covering intake through submission — configured to reflect how your safety team already works.
ICSR intake, triage & coding
Case intake, triage, and MedDRA / WHO-DD coding in one workflow.
Narrative writing support
Structured tools to draft and standardize case narratives.
E2B(R3) electronic submissions
Direct electronic submission to regulatory gateways in E2B(R3) format.
Aggregate reporting
PSUR / PBRER / DSUR generation, built from your live case data.
Signal detection & validation
Ongoing signal detection with a structured validation workflow.
Executive dashboards
Real-time visibility into case status and compliance tracking.
WhatsApp intake
Capture spontaneous reports where reporters already are, with NDPR consent.
QMS / SOP integration
Reflects your existing safety governance rather than forcing a new one.
Built by the team that runs your safety operations
Platform and people, aligned
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.
African regulatory realities, from day one
Configured for African regulatory realities from the start, rather than adapted from a US/EU system after the fact.
Integrated across the lifecycle
Connected to MedNova's Regulatory Affairs and Clinical Development services, so safety data links directly to registration and trial-safety workflows.
Flexible deployment
From a fully managed service to a self-administered licensed instance for teams that want to run it in-house.