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Anotace knihy

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. How to conduct clinical trials are described in detail are described in detail Useful basic and advanced statistical tools are included 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

Parametry knihy

Zařazení knihy Knihy v angličtině Economics, finance, business & management Industry & industrial studies Manufacturing industries

• Plný název: Clinical Trial Project Management
• Autor: Ashok Kumar Peepliwal
• Jazyk: Angličtina
• Vazba: Brožovaná
• Počet stran: 330
• EAN: 9780443136276
• ID: 43445353
• Rozměry: 229 × 152 mm
• Datum vydání: 01. January 2024

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