Clinical Trial Project Management
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Project Management In Clinical Trials
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Author : Alexey Levashov
language : en
Publisher: Litres
Release Date : 2021-05-25
Project Management In Clinical Trials written by Alexey Levashov and has been published by Litres this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-05-25 with Business & Economics categories.
The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life and practical tips.
12 Essential Activities Of Clinical Trial Project Management
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Author : T. C. George, Dr.
language : en
Publisher: CreateSpace
Release Date : 2014-11-01
12 Essential Activities Of Clinical Trial Project Management written by T. C. George, Dr. and has been published by CreateSpace this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-01 with Medical categories.
The book includes 12 essential activities undertaken by a project manager which includes Project Milestones Planning and Forecasting, Cost Estimate and Financial Planning, Logistics Planning, Vendor Selection and Management, Creation of Trial Master file, Management of Regulatory Document Submission, Co-ordination of Individual Site Set-up Activities, Import Export Requirements for Clinical Trials, Organization of Investigator Training Meeting, Study Initiation, Conduct and Milestones Tracking, Audit(s) and Quality Assurance, Regulatory Inspection, Study Closeout: Trial Completion, Suspension, Termination.
Clinical Trial Project Management
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Author : Martin Robinson
language : en
Publisher: Inst of Clinical Research
Release Date : 2008
Clinical Trial Project Management written by Martin Robinson and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Clinical trials categories.
Clinical research projects are frequently complex and may have a large element of uncertainty both during their conduct and in their final outcome. This book sets out to give tools and techniques to plan, track and conrol projects in clinical research.
Project Management Of Clinical Trials
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Author : Richard Chamberlain
language : en
Publisher: Xlibris Corporation
Release Date : 2019-09-24
Project Management Of Clinical Trials written by Richard Chamberlain and has been published by Xlibris Corporation this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-24 with Medical categories.
Project Management of Clinical Trials describes how to apply project management principles to conduct clinical research studies. It describes the major deliverables from clinical research and then covers estimating dates, resources, and costs to produce those deliverables. Along with the book is a set of Excel spreadsheets that can be used to estimate the dates and costs to do different types of clinical trials.
Clinical Trial Project Management
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Author : Ashok Kumar Peepliwal
language : en
Publisher: Elsevier
Release Date : 2023-11-15
Clinical Trial Project Management written by Ashok Kumar Peepliwal and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-15 with Business & Economics categories.
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. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides 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
Project Management
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Author : Nancy J. Stark
language : en
Publisher:
Release Date : 2003
Project Management written by Nancy J. Stark and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Medical instruments and apparatus categories.
"Complex to implement and insidious in their propensity for cost overruns and schedule delays, poorly managed clinical trials may postpone marketing applications and result in expensive "lost opportunities". In this book the traditional skills of project management -- conception, planning, implementation, monitoring, and close-out -- are applied to clinical research to help assure smooth implementation and on-time completion."--Clinical Device Group website.
Project Management For Drug Developers
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Author : Joseph P. Stalder
language : en
Publisher: CRC Press
Release Date : 2022-12-29
Project Management For Drug Developers written by Joseph P. Stalder and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-29 with Medical categories.
Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.
Project Management For The Pharmaceutical Industry
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Author : Mr Tony Grundy
language : en
Publisher: Gower Publishing, Ltd.
Release Date : 2012-09-28
Project Management For The Pharmaceutical Industry written by Mr Tony Grundy and has been published by Gower Publishing, Ltd. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-28 with Business & Economics categories.
The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.
Clinical Studies Management
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Author : Simon Cook
language : en
Publisher: CRC Press
Release Date : 2004-01-15
Clinical Studies Management written by Simon Cook and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-01-15 with Medical categories.
What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies. The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change. If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.
Project Management For The Pharmaceutical Industry
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Author : Laura Brown
language : en
Publisher: Routledge
Release Date : 2016-04-08
Project Management For The Pharmaceutical Industry written by Laura Brown and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-08 with Business & Economics categories.
The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.