Pharmacovigilance & Safety Reporting

Mednet's Pharmacovigilance & Safety Reporting solution is an integrated module within the iMednet eClinical platform, purpose-built to streamline adverse event reporting and strengthen regulatory compliance across global clinical programs. Designed for pharmacovigilance and clinical teams at research sponsors and CRO partners, it enables accurate capture, management, and submission of adverse event cases while maintaining full alignment with international regulatory standards.

By combining automation, real-time oversight, and seamless system integration, the solution reduces operational complexity and enhances visibility and control across the entire safety lifecycle — helping organisations protect patients and maintain regulatory trust.

Regulatory-Compliant Case Reporting

• Built-in support for ICH E2B(R3) standards, positioning sponsors ahead of the 2026 enforcement deadline for structured electronic submissions in clinical trials.
• Direct submission gateways to major regulatory agencies including the FDA, EMA, CDE, MFDS, and PMDA.
• Reduces manual effort and increases submission accuracy through pre-configured regional regulatory requirements.

Workflow Automation and AI Assistance

• Native AI-assisted features recommend medical coding terms to accelerate case processing.
• Automated duplicate record prevention reduces data entry errors and manual workload.
• Simplified data entry workflows optimise overall case management efficiency.

Real-Time Tracking and Validation

• Real-time tracking of submissions and regulatory responses provides continuous operational visibility.
• Built-in validation controls ensure higher data quality throughout the case lifecycle.
• Duplication controls support consistent and reliable case management practices.

Proactive Safety Signal Detection

• Integrated signal detection module included at no additional cost.
• Automated algorithms support the identification, prioritisation, and validation of potential safety signals.
• Enables teams to detect emerging safety trends early and focus resources on the most critical issues.

Seamless Integration with Clinical Systems

• Direct integration with the broader iMednet eClinical platform eliminates redundant data entry.
• Enables a seamless flow of adverse event data from study capture through to regulatory submission.
• Reduces data silos and improves operational efficiency for safety reporting in clinical trials.

Cost Savings and Value

• Delivers up to 80% cost savings compared to traditional pharmacovigilance solutions.
• Maintains full compliance and data quality standards while reducing overall operational costs.

The Pharmacovigilance & Safety Reporting module is part of Mednet's comprehensive EDC-centric iMednet eClinical platform, which also includes native modules for randomisation and trial supply management, adjudication, ePRO, payments, DICOM imaging, eConsent, and more — supporting all study types and phases within a single integrated environment.