Clinical Trial Project Management (Paperback) (ISBN-13: 9780443136276)

Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.

Author: Ashok Kumar Peepliwal
ISBN-10: 0443136270
ISBN-13: 9780443136276
Publisher: Academic Press
Language: English
Published: 11/14/2023
Pages: 350
Format: Paperback
Weight: 1.80lbs
Size: 11.00h x 8.50w x 0.73d