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Clinical Trial Project Management

€24.00
Clinical Trial Project Management
one year full access code to all e-books of this bookshop: €100 ! contact us to get your code.

Clinical Trial Project Management

€24.00

by Ashok Kumar Peepliwal (Author) 

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.

  • Covers how to conduct clinical trials in detail
  • Present useful, basic, and advanced statistical tools
  • Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book
Year:
2024
Pages:
336
Language:
English
Format:
PDF
Size:
8 MB
ASIN:
B0CNGQ5PR4
ISBN-10:
0443136270, 0443136289
ISBN-13:
9780443136276, 978-0443136276, 978-0-443-13627-6, 9780443136283, 978-0443136283