Principles and Practice of Pharmacovigilance & Clinical Data Management
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Description
In the rapidly evolving era of drug development, the integrity of clinical data and the safety of patients are paramount. Principles and Practice of Pharmacovigilance & Clinical Data Management serves as a bridge between academic knowledge and the practical skills required in the pharmaceutical and CRO (Contract Research Organization) industries.
This textbook is meticulously designed for students and faculty who aspire to master the twin pillars of clinical research. Unlike generic guides, this book offers a unified approach, explaining how Clinical Data Management (CDM) ensures data accuracy while Pharmacovigilance (PV) ensures drug safety, and how these two functions intertwine to bring safe medicines to market.
Readers will be guided through the entire lifecycle of a drug from the initial design of Case Report Forms (CRFs) to the post-marketing surveillance of adverse events. Featuring real-world case studies, industry-standard workflows (such as Oracle Argus and Medidata Rave simulations), and detailed explanations of global regulatory guidelines (ICH-GCP, FDA, EMA), this book is not just a study guide; it is a job-ready career roadmap
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