Clinical Trial Project Management

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 etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials.

General

Imprint:	Academic Press Inc
Country of origin:	United States
Release date:	November 2023
First published:	2024
Authors:	Ashok Kumar Peepliwal
Dimensions:	229 x 151mm (L x W)
Pages:	330
ISBN-13:	978-0-443-13627-6
Categories:	Books Promotions
LSN:	0-443-13627-0
Barcode:	9780443136276

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