Pharmacovigilance & Safety Reporting
Streamline adverse event reporting and strengthen regulatory compliance with an integrated pharmacovigilance solution designed to support global clinical programs.
Our safety reporting capabilities enable pharmacovigilance and clinical teams to accurately capture, manage, and submit adverse event cases while maintaining full alignment with international regulatory standards. Through automation, real-time oversight, and seamless system integration, safety operations become more efficient, scalable, and audit-ready.
Accurate, timely safety reporting is critical to protecting patients and maintaining regulatory trust. This solution reduces operational complexity while enhancing visibility and control across the safety lifecycle.
Regulatory-compliant Case Reporting
With ICH E2B(R3) enforcement coming in 2026, sponsors must be ready for structured electronic submissions, even in clinical trials. Submit adverse event reports confidently with built-in support for ICH E2B standards and regional regulatory requirements. Direct gateways to agencies such as the FDA, EMA, CDE, MFDS, and PMDA reduce manual effort and increase submission accuracy.
Efficient Workflow Automation & AI Assistance
Workflows are optimized with native AI-assisted features that recommend medical coding terms, help prevent duplicate records, and simplify data entry – accelerating case processing and reducing manual workload.
Real-Time Tracking & Validation
Track submissions and regulatory responses in real time. Built-in validation and duplication controls ensure higher data quality and support consistent case management.
Proactive Safety Signal Detection
Identify emerging safety trends early with our integrated signal detection module, included at no additional cost. Automated algorithms support the identification, prioritization, and validation of potential signals, enabling teams to focus on what matters most.
Seamless Integration with Clinical Systems
Direct integration with the iMednet platform eliminates redundant data entry and enables a seamless flow of adverse event data from study capture to regulatory submission – reducing silos and improving operational efficiency for safety reporting in clinical trials.
Proven Cost-savings up to 80%
Schedule a demo to learn how our solution delivers up to 80% cost savings compared to traditional solutions – without compromising compliance or data quality.
A Complete Solution
Contact us for an introduction to Mednet's comprehensive EDC-centric eClinical platform with key native modules to support all study types and phases – such as randomization, trial supply management, adjudication, ePRO, payments, DICOM imaging, eConsent and more.