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Opis

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

Szczegóły książki

Kategoria Książki po angielsku Economics, finance, business & management Industry & industrial studies Manufacturing industries

• Pełny tytuł: Clinical Trial Project Management
• Autor: Ashok Kumar Peepliwal
• Język: Angielski
• Oprawa: Miękka
• Liczba stron: 330
• EAN: 9780443136276
• ID: 43445353
• Wymiary: 229 × 152 mm
• Data wydania: 01. January 2024

Ulubione w innej kategorii

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