Pharmacovigilance Software: When Biotechs Need a Database
Analyze when biotechs need pharmacovigilance software. Covers FDA safety database requirements, compliance risks, and solution options for clinical trials.
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Articles tagged with “adverse-event-reporting”
AE vs SAE vs SUSAR: Key Differences in Safety Reporting
Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. Updated for 2026 with ICH E6(R3), EU CTR 536/2014 CTIS, FDA Dec 2025 guidances, and ICH E2B(R3) mandate. Covers definitions, causality, and expedited reporting timelines.
Top Pharmacovigilance Providers: A Market & Vendor Guide
An educational guide to leading pharmacovigilance service providers (updated April 2026). Learn about the PV outsourcing market, regulatory drivers including FDA AEMS and EU AI Act, and compare top drug safety CROs including Fortrea, IQVIA, ICON, and more
An Overview of Pharmacovigilance (PV) Software Systems
Updated for 2026, this article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, agentic AI developments, and a comparison of leading platforms including Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, and more.
AI Agents in Pharmacovigilance: A Technical Overview
An overview of AI agents in pharmacovigilance (PV), covering agentic AI, generative AI, and ML applications in safety data processing, ICSR management, and signal detection, with updates on the CIOMS WG XIV final report, FDA's Elsa tool, and EU AI Act requirements.
The FDA Adverse Event Reporting System (FAERS) Explained
Learn about the FDA Adverse Event Reporting System (FAERS), now updated in real time with over 31 million reports, for post-marketing drug safety surveillance, signal detection, and AI-enhanced pharmacovigilance.