Short Literature Review on Pharmaceutical Regulatory Affairs with Significance of Artificial Intelligence, Machine Learning and Big Data for Clinical Trial Validation Process Automation

Abstract

Regulatory Affairs are umbrella activities for drug discovery, medical devices discovery and clinical trials throughout the world. There are diversified rules and regulations for the validation of criteria among them. However, as a post-covid-19 pandemic scenario, automation in the field of pharmaceutical is promoted worldwide. One of such upcoming research domain is artificial intelligence for process automation. Hence, this paper presents the empirical literature review where similar to pharmaceutical expert as a medical coder; there is a need of artificial intelligence strategy and big data storage facility provider with the knowledge of pharmaceutical domain. The validation of compliances processes in regulatory affairs is crucial and multidisciplinary research is necessary. This review presents the need of artificial intelligence, machine learning and big data analytics for fast and precise execution of validation process of clinical trial data.