The World Health Organization defines pharmacovigilance as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Notably, Pharmacovigilance scope requires structured processes, controlled documentation, and continuous oversight, which directly aligns with quality management systems.  It is essential to understand how pharmacovigilance operates within quality […]

QMS creates a controlled quality environment where clinical research activities remain aligned with regulatory standards, organisational procedures, and audit requirements throughout the study lifecycle. This guide explains how QMS (particularly eQMS) operates within clinical research, how it connects with daily study execution, and how it ensures compliance, traceability, and audit readiness across the study lifecycle.

Document and Quality Management refers to the structured, systematic processes involved in handling, tracking, and ensuring the quality of research data, documentation, and operations throughout the study lifecycle.  Notably, data management in clinical research goes beyond merely storing documents or managing tasks. In fact, it requires an integrated approach that ensures every element of the