Clinical Safety & Pharmacovigilance

At POPAMED, we prioritize the safety and well-being of patients by providing robust Clinical Safety and Pharmacovigilance services. As a full-service Contract Research Organization (CRO), we partner with sponsors to ensure that all safety-related activities adhere to global regulatory requirements while fostering confidence in your clinical research outcomes.

Our Clinical Safety & Pharmacovigilance Services

Adverse Event Monitoring and Management
We provide comprehensive monitoring, reporting, and management of adverse events (AEs) and serious adverse events (SAEs) to safeguard participants’ safety and ensure timely regulatory reporting.

Risk Assessment and Mitigation
Our experts conduct risk assessments throughout the trial lifecycle, implementing proactive measures to address potential safety concerns.

Safety Data Management
Utilizing advanced systems, we collect, analyze, and manage safety data to provide accurate, real-time insights that inform decision-making.

Periodic Safety Reporting
We prepare detailed safety reports, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs), ensuring compliance with regulatory timelines and standards.

Signal Detection and Risk Evaluation
Our pharmacovigilance specialists identify and evaluate safety signals to maintain the highest standards of participant safety.

Regulatory Compliance
POPAMED’s team ensures that all pharmacovigilance activities comply with local and international regulations, including ICH guidelines, FDA requirements, and EMA standards.

Post-Marketing Surveillance
Beyond clinical trials, we support post-approval safety monitoring to ensure the long-term safety of marketed products.

Why Choose POPAMED for Pharmacovigilance?

With a deep understanding of clinical safety and pharmacovigilance, POPAMED delivers tailored solutions that integrate seamlessly into your trial processes. Our commitment to quality and regulatory excellence ensures participant safety while enabling sponsors to bring safer, more effective therapies to market.