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.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Dr. Ashok Kumar Peepliwal holds a PhD in Pharmaceutical Sciences, Bachelor of Pharmacy, LLB, MBA (Human Resource Management). He has extensive experience in conducting clinical trials and project management: including regulatory dossier submission, protocol approvals, site selection, site initiation, site monitoring, and site close-out etc. He has more than 19 years of experience in the pharmaceutical industry (clinical research) and academics as well. Currently he is working as an associate professor at the School of Pharmaceutical Management, IIHMR University
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 46659256
Quantité disponible : Plus de 20 disponibles
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : New. N° de réf. du vendeur 46659256-n
Quantité disponible : Plus de 20 disponibles
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 46659256
Quantité disponible : Plus de 20 disponibles
Vendeur : moluna, Greven, Allemagne
Etat : 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. N° de réf. du vendeur 897996062
Quantité disponible : Plus de 20 disponibles
Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : New. N° de réf. du vendeur 46659256-n
Quantité disponible : Plus de 20 disponibles
Vendeur : Revaluation Books, Exeter, Royaume-Uni
Paperback. Etat : Brand New. 330 pages. 9.00x5.94x0.83 inches. In Stock. N° de réf. du vendeur x-0443136270
Quantité disponible : 2 disponible(s)
Vendeur : AHA-BUCH GmbH, Einbeck, Allemagne
Taschenbuch. Etat : 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. N° de réf. du vendeur 9780443136276
Quantité disponible : 2 disponible(s)