Pharmacovigilance guides
Practical, in-depth guides on drug safety operations — from ICSR case processing and E2B submission to signal detection, compliance, and software selection.
All guides
Cornerstone articles for PV teams, CROs, and small-to-mid pharma evaluating modern, affordable drug-safety software.
Affordable Pharmacovigilance Software for CROs and Small Pharma in India
Enterprise safety suites were built for large pharma with big IT teams. This guide explains how CROs and small-to-mid pharma — especially in India — can run a complete, compliant PV operation on a modern, affordable, cloud platform.
Oracle Argus Alternatives: Affordable PV Software Compared (2026)
Oracle Argus Safety dominates the pharmacovigilance market, but it is not the right fit for every team. This guide explains when to consider an alternative and what a modern, affordable replacement should offer.
What Is ICSR Case Processing? The Full Workflow Explained
An Individual Case Safety Report (ICSR) is the core unit of pharmacovigilance. This guide walks through the complete case-processing workflow — from multi-channel intake to regulatory submission — and shows where automation helps and where qualified people stay in control.
E2B(R2) vs E2B(R3): A Practical Guide for PV Teams
E2B is the ICH standard for exchanging Individual Case Safety Reports electronically. This guide explains the practical differences between the older E2B(R2) and the current E2B(R3), and what they mean for your submissions.
Signal Detection Methods Compared: PRR, ROR, BCPNN, and EBGM
Disproportionality analysis is the backbone of statistical signal detection. This guide compares the four methods you will meet most often — PRR, ROR, BCPNN/IC, and EBGM — in plain language, with their strengths and limitations.
Aggregate Reporting Explained: DSUR, PBRER/PSUR, and PADER
Beyond individual cases, pharmacovigilance requires periodic aggregate reports that summarise a product's safety over time. This guide explains the main report types — DSUR, PBRER/PSUR, and PADER — and what they involve.
Literature Monitoring in Pharmacovigilance: A Practical Guide
Regulators expect marketing authorisation holders to monitor the scientific literature for adverse events. This guide explains the literature monitoring workflow, the obligations behind it, and how AI-assisted screening helps.
21 CFR Part 11 Compliance in Pharmacovigilance Explained
21 CFR Part 11 is the FDA rule governing electronic records and electronic signatures. This guide explains what it means for a pharmacovigilance system, the controls it requires, and how it connects to validation and GAMP 5.