Product Safety and Pharmacovigilance
Protecting patients,
ensuring compliance
The Signal Detection Paradox:
Seeing What Matters, Ignoring the Noise
Patient safety is at the heart of every clinical trial and marketed therapy. At Rho, we take a proactive approach to pharmacovigilance, ensuring that safety monitoring is embedded seamlessly into trial execution and post-market surveillance. Our team combines scientific expertise, real-time data analysis, and global regulatory knowledge to safeguard patients and support regulatory success.
Why Rho?
Why Rho?
Integrated safety oversight
Pharmacovigilance is embedded into trial design, execution, and post-market monitoring.
Expert case management
Efficient processing and reporting of adverse events, serious adverse events, and safety signals.
Regulatory intelligence
Expertise in FDA, EMA, and global pharmacovigilance requirements.
Risk mitigation strategies
Identifying and addressing safety concerns early to prevent delays and ensure patient well-being.
Comprehensive pharmacovigilance support
We provide full-spectrum pharmacovigilance services to ensure regulatory compliance and patient safety:
Clinical trial safety management
End-to-end safety oversight, from protocol development to study closeout.
Post-marketing pharmacovigilance
Monitoring safety data and fulfilling global reporting obligations.
Signal detection and risk management
Identifying and responding to emerging safety concerns.
Aggregate reporting and regulatory submissions
Preparation of DSURs, PSURs, and PBRERs.
Safety database management
Secure, compliant data capture and reporting for regulatory authorities.
Related insights & resources
Ready to take a proactive approach to patient safety?
Ensuring safety isn’t just about meeting requirements—it’s about protecting people. Let’s build a safety strategy that strengthens your trial and regulatory success.
