Project Management Of Clinical Trials
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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.
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.
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.
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 : 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
Product Based Planning
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Author : David James Bryde
language : en
Publisher:
Release Date : 2008
Product Based Planning written by David James Bryde and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
As the cost of clinical trials continues to rise organizations are looking at ways of managing this part of the drug development process as effectively and efficiently as possible. As a tactical response, many pharmaceutical companies outsource the management of clinical trials to clinical research organizations on a fixed-price contract basis. This paper presents an alternative approach based on the concept of Product-Based Planning. Key elements of the approach are the creation of a deliverables budget and the establishment of project management-related deliverables. The conceptual developments described in the paper are supported by a telephone survey of 10 UK practitioners. The survey confirms the prevalence and limitations of fixed-price contracts while highlighting a willingness to try a deliverable-based approach initially through small pilot studies. The key barrier to implementing a new approach is resistance from key stakeholders, such as finance departments, which can be addressed through selling of the business case.
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.
Project Management For Clinical Trials
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Author : Nancy J. Stark
language : en
Publisher:
Release Date : 1999-03
Project Management For Clinical Trials 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 1999-03 with categories.
Leadership Competencies Of A Clinical Trial Project Manager
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Author : John Petrera
language : en
Publisher: Fulton Books, Inc.
Release Date : 2024-06-17
Leadership Competencies Of A Clinical Trial Project Manager written by John Petrera and has been published by Fulton Books, Inc. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-17 with Business & Economics categories.
"Leadership competencies of a clinical trial project manager" is unique in that this qualitative inquiry research project not only explores the specific top leadership competencies of project managers involved in pharmaceutical clinical trials, but the concepts reviewed in this book are applicable broad spectrum to multiple professional fields. The proposed leadership framework combines elements of leadership competencies, project management competencies, personal competencies, and includes a review of the leadership types from the traits theory of leadership. The leadership concepts described are universal and can be applied to improve any leader's abilities. While this book focuses on clinical trial project managers, the concepts and best practices apply to all PMs within pharmaceuticals or in any other field. The derived PM competency framework is transferrable to PMs in numerous industries and may also provide applicable guidance to others, regardless of their profession. Ultimately, the expansion of the PM triangle is a useful concept that many will find interesting. Additionally, personal competencies can improve personal effectiveness, achievements, and actions. This project identified 5 themes to include (a) CTPM experience and knowledge, (b) leadership competencies, (c) leadership types (styles), (d) personal competencies, and (e) project management competency development (PMCD). The 5 themes identified are all critical to understanding the perspectives obtained from the study participants regarding leadership competencies to maximize efficiencies of research and development. The results of this study can (a) potentially assist new CTPMs, (b) provide a refresher for CTPMs seeking improvement, (c) provide support for project managers in general, and (d) may assist hiring managers in determining the leadership skills to seek. The results from this study may support the project, program, and portfolio managers from various industries to better understand the leadership competencies and the overall framework that support project management. At the same time, these 5 themes, interpreted in the broadest terms, may be helpful to you!