Abstract

Maroju Manasa Priya*, Viswakanth Makutam, Shaikh Mohmed Adnan Mohmed Javid, Mohammad Safwan R. S., Morziul Haque, Tanwir Ahamad, Alapati Sathya Sai Guptha, Kohale Dhiraj Arvind, Anannya Mathew and Dr. Srinivasarao Varagani

ABSTRACT

Ensuring the accuracy, consistency, and regulatory compliance of trial data is made possible through the crucial process of clinical data management (CDM). The setup, conduct, and closeout phases—the three main stages of the CDM process—are all covered in detail in this review. Protocol evaluation, data management planning, and system validation are all part of the initial deployment process. To preserve data integrity during the conduct phase, data collection, cleaning, and monitoring are crucial. Final data validation, analysis, reporting, and archiving are all part of the closeout step. The review also emphasizes the important role that Pharm.D. professionals play in CDM, highlighting their knowledge of clinical practice, pharmacology, and regulatory compliance. Pharm.D. experts support each stage by navigating difficult regulatory regulations, guaranteeing patient safety, and offering insights into drug-related data. Pharm.D. experts are becoming more and more important in utilizing technological breakthroughs like blockchain and artificial intelligence to improve data management processes as CDM continues to change. This evaluation emphasizes how crucial it is to include Pharm.D. specialists in the CDM process in order to promote advancements and guarantee the effective conduct of clinical trials.