At Amarex Clinical Research, we are redefining the future of pharmacovigilance (PV) and post-market surveillance (PMS) through the power of artificial intelligence (AI) and ISO 14971-aligned risk management. Our intelligent safety solutions are designed to help pharmaceutical, biologic, and medical device companies detect risks earlier, respond faster, and ensure global regulatory compliance—while reducing operational burden and improving ROI.

Why Choose Amarex for PV & PMS?

• Real-Time Signal Detection: Harness the power of machine learning and predictive analytics to identify emerging safety signals across electronic health records (EHRs), social media, and global safety databases—before they escalate into regulatory issues.
• Automated Case Processing: Streamline intake, triage, narrative generation, and medical coding with natural language processing (NLP) tools that reduce manual workload and improve consistency across safety reports.
• AI-Powered Literature Screening: Rapidly scan thousands of global publications and regulatory alerts to identify relevant safety data, ensuring no critical information is missed and compliance is maintained.
• Precision Risk Management: Use AI and real-world data to tailor risk mitigation strategies to specific patient populations. Our ISO 14971-aligned assessments and Health Hazard Analyses (HHAs) ensure defensible, audit-ready documentation.
• Global Regulatory Compliance: From ICSRs to PSURs and PBRERs, we ensure timely, accurate submissions to health authorities including the FDA, EMA, PMDA, and more—keeping you compliant across all markets.

What Sets Amarex Apart?

• Cost Savings: Reduce reliance on internal FTEs or consultants
• Speed to Resolution: Accelerate complaint handling and risk assessments
• Scalability: On-demand support during audits, recalls, or complaint spikes
• Regulatory Confidence: ISO 14971-compliant processes and documentation
• Strategic Focus: Free up your internal teams to focus on innovation and growth

Let’s Build a Safer, Smarter Future Together