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Public Authorities and Safety

SUGAM Portal: Complete Guide to CDSCO’s Online Regulatory System

This article provides a complete overview of the SUGAM portal, its purpose, major applications, key features, and its importance in India’s clinical ecosystem.

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ICSR Management

SAR vs SAE in Pharmacovigilance: Definitions, Differences, & Key Concepts

This article explains the definitions, highlights the critical differences between SAR and SAE, and explores the key concepts in pharmacovigilance.

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Techs & Tools

Enhancing Pharmacovigilance with NLP and Text Mining

This article provides an overview of NLP applications in pharmacovigilance, including literature review, data extraction, AE identification, and annotations.

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Exploring Adverse Events

FDA FAERS Analysis: Rising Trends in Serious Adverse Events Reports

This blog features: Introduction In this article we discuss about the trends of adverse event reporting which are…

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ICSR Management

Country Attribution in ICSRs: Rules, Challenges, & Best Practices

A quick guide to country attribution in ICSRs and their role in ensuring accurate, compliant safety reporting.

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Literature Screening

Open-Source Literature Review: A Practical Guide

A practical guide to open-source literature review, highlighting free tools and workflows to streamline research from search to systematic review.

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Talk About Quality

IDMP Standards Explained: Importance and Benefits for Clinical Projects

This article explores the importance of IDMP standards in clinical projects and highlights the key benefits they bring to data consistency, regulatory compliance, and global information exchange.

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Drug safety and pharmacovigilance

What are IME listings?

This article provides an overview of Important Medical Event (IME) listings, their development, and their role in pharmacovigilance.

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