Module 12 Presentations

Key Definitions 1. Big Data o

High-volume, high-velocity and/or high-variety information assets that demand cost-effective, innovative forms of information processing that enable enhanced insight, decision making, and process automation o E.g. Electronic Health Records, Genomic Information, Real World Data (below), Patient Reported Outcomes, Published Study data, Scientific Literature, Pharmacovigilance data etc. and this refers to Clinical generated data only!

Source: https://itrexgroup.com/blog/bi g-data-in-pharma-definition-use-cases

The Organisation for Professionals in Regulatory Affairs