Articles tagged with “pharmacovigilance”

Learn how AI and machine learning analyze Real-World Data (RWD) to generate Real-World Evidence (RWE). Explore key applications, benefits, and challenges.

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. This guide explains CCDS and how Vault Signal accelerates

A guide to Reference Safety Information (RSI) in clinical trials. Learn the regulatory framework, common pitfalls, and how to avoid SUSAR reporting errors.

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

Learn how MedDRA and WHODrug standardize coding for adverse events and medications in clinical trials. This guide covers their structure, use, and best practice

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. This guide clarifies definitions, causality, and expedited reporting timel

An educational guide to leading pharmacovigilance service providers. Learn about the PV outsourcing market, regulatory drivers, and compare top drug safety CROs

An in-depth analysis of pharmaceutical compliance software for GxP and QMS. Learn key features for 21 CFR Part 11 and compare top vendors like Veeva & MasterCon

Learn about the modern pharmacovigilance tech landscape. This guide explains key systems, AI/ML for signal detection, PV automation, and data standards for drug

Get a detailed guide to Oracle Life Sciences solutions. Learn about key products for clinical trials (Clinical One) and pharmacovigilance (Argus Safety).

Learn about synthetic data in pharmaceutical research. This guide covers acceptance criteria like fidelity, utility, and privacy for clinical and pharmacovigila

This article provides a technical overview of pharmacovigilance software, detailing core functions, regulatory compliance, and a comparison of leading platforms.

An overview of AI agents in pharmacovigilance (PV), detailing their application in processing safety data and managing the increasing volume of ICSRs.

Learn about the FDA Adverse Event Reporting System (FAERS), a database for post-marketing drug safety surveillance and detecting new adverse event signals.

An overview of AI in pharmacovigilance, detailing its use in signal detection, case processing automation, and managing regulatory & ethical considerations.

Explore real-world case studies of how pharmaceutical companies are leveraging big data, AI, and cloud computing across the drug lifecycle - from discovery to marketing - with measurable outcomes and lessons learned.

Comprehensive analysis of big data technologies used in pharmaceutical industry, including Hadoop, Spark, cloud data warehouses, NoSQL databases, and specialized genomics platforms, with detailed comparisons and implementation examples.

Comprehensive overview of Oracle's role in the pharmaceutical industry, covering their Health Sciences solutions, cloud infrastructure, compliance features, and case studies of successful implementations at major pharma companies.

A comprehensive overview of the most influential open-source software tools transforming pharmaceutical research, development, and manufacturing, from cheminformatics to clinical data management and regulatory compliance.