ISBN: 9780443136276 - clinical trial project management (4 Ergebnisse)

Zustand: As New. Unread book in perfect condition.

Zustand: New. Covers how to conduct clinical trials in detailPresent useful, basic, and advanced statistical toolsProvides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to man.

Paperback. Zustand: Brand New. 330 pages. 9.00x5.94x0.83 inches. In Stock.

Taschenbuch. Zustand: Neu. Neuware - 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.…