At Prime Services, patient safety is more than a requirement—it's our priority. Our Pharmacovigilance team ensures that every safety signal is captured, assessed, and communicated effectively, so your clinical trials stay compliant and trusted.
At Prime Services, patient safety is more than a requirement—it's our priority. Our Pharmacovigilance team ensures that every safety signal is captured, assessed, and communicated effectively, so your clinical trials stay compliant and trusted.
We gather safety data from multiple trusted sources—CRFs, EDC systems, spontaneous reports, literature, and even social media. Using validated safety databases, we ensure the security, accuracy, and traceability of every safety record in line with global regulations.
Our experts apply advanced techniques for signal detection, causality assessment, and benefit-risk evaluation. We deliver critical reports like PSURs, aggregate safety summaries, and signal management dossiers to ensure potential risks are identified and mitigated early.
From ICSRs and expedited reports to safety narratives, RMPs, and regulatory submissions, we manage every aspect of pharmacovigilance reporting. We maintain compliance with all major regulatory guidelines (e.g., ICH, EMA, FDA) and provide timely communication with sponsors, investigators, and authorities.
| End-to-End Safety Management | Real-Time Safety Monitoring Systems |
| Global Regulatory Compliance | Proven Expertise |
We safeguard patient health and uphold scientific integrity by proactively monitoring and managing drug/device safety.