Clinical Trial Project Management - Softcover

Peepliwal

Softcover

ISBN 10: 0443136270 ISBN 13: 9780443136276

Verlag: Academic Press, 2023

Inhaltsangabe

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.

Über diesen Titel

Über die Autorin bzw. den Autor

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

Von der hinteren Coverseite

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.

Details zur Ausgabe

• Verlag: Academic Press
• Erscheinungsdatum: 2023
• Sprache: Englisch
• ISBN 10: 0443136270
• ISBN 13: 9780443136276
• Einband: Taschenbuch
• Anzahl der Seiten: 350
• Kontakt zum Hersteller: Academic Press; https://shop.elsevier.com/; ; 230 PARK AVENUE, SUITE 800; NY; NY; 10169; USA
• Verantwortliche Person: GPSR Kontakt; gpsr@libri.de; ; Friedensallee 273; Hamburg; 22763; Deutschland