Global Clinical Trials Playbook

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Produk Detail:

  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Pages : 320 pages
  • ISBN : 0124158609
  • Rating : 5/5 from 1 reviews
CLICK HERE TO GET THIS BOOKGlobal Clinical Trials Playbook

Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher : Academic Press
  • Release : 12 June 2012
GET THIS BOOKGlobal Clinical Trials Playbook

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety

Global clinical trials playbook : management and implementation when resources are limited

Global clinical trials playbook : management and implementation when resources are limited
  • Author : Menghis Bairu,Richard Yoonsik Chin
  • Publisher : Unknown Publisher
  • Release : 27 February 2021
GET THIS BOOKGlobal clinical trials playbook : management and implementation when resources are limited

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release : 06 May 2011
GET THIS BOOKGlobal Clinical Trials

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher : Academic Press
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
  • Author : Delva Shamley,Brenda Wright
  • Publisher : Academic Press
  • Release : 07 June 2017
GET THIS BOOKA Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care
  • Author : Abdul Kader Mohiuddin
  • Publisher : Universal-Publishers
  • Release : 27 February 2021
GET THIS BOOKThe Role of the Pharmacist in Patient Care

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
  • Author : Richard Chin,Bruce Y Lee
  • Publisher : Elsevier
  • Release : 25 July 2008
GET THIS BOOKPrinciples and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting

Bad Science

Bad Science
  • Author : Ben Goldacre
  • Publisher : McClelland & Stewart
  • Release : 12 October 2010
GET THIS BOOKBad Science

The informative and witty expose of the "bad science" we are all subjected to, called "one of the essential reads of the year" by New Scientist. We are obsessed with our health. And yet — from the media's "world-expert microbiologist" with a mail-order Ph.D. in his garden shed laboratory, and via multiple health scares and miracle cures — we are constantly bombarded with inaccurate, contradictory, and sometimes even misleading information. Until now. Ben Goldacre masterfully dismantles the questionable science behind some

Cytokine Storm Syndrome

Cytokine Storm Syndrome
  • Author : Randy Q. Cron,Edward M. Behrens
  • Publisher : Springer Nature
  • Release : 09 September 2019
GET THIS BOOKCytokine Storm Syndrome

Cytokine Storm Syndromes, including HLH and MAS, are frequently fatal disorders, particularly if not recognized early and treated during presentation. The genetics of Cytokine Storm Syndromes are being defined with many of the risk alleles giving rise to mutations in the perforin-mediated cytolytic pathway used by CD8 cytotoxic T cells and natural killer cells. These are being studied using murine models. Up to 10% of the general population may carry risk alleles for developing Cytokine Storm Syndromes, and Cytokine Storm Syndromes

The Importance of Pharmacovigilance

The Importance of Pharmacovigilance
  • Author : World Health Organization
  • Publisher : Unknown Publisher
  • Release : 01 January 2002
GET THIS BOOKThe Importance of Pharmacovigilance

The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

The Online Advertising Playbook

The Online Advertising Playbook
  • Author : Joe Plummer,Stephen D. Rappaport,Taddy Hall,Robert Barocci
  • Publisher : John Wiley & Sons
  • Release : 20 July 2007
GET THIS BOOKThe Online Advertising Playbook

Praise for The Online Advertising Playbook "Finally, someone has documented all we know about online advertising and how to do it right. As much as this confirms that online advertising really works, we know that marketers don't always get it right. The ARF's The Online Advertising Playbook provides critical insight on what sticks and what doesn't in online advertising and marketing." —Greg Stuart, CEO and President, Interactive Advertising Bureau and coauthor of What Sticks "The Online Advertising Playbook's principles, case

Data and Safety Monitoring Committees in Clinical Trials

Data and Safety Monitoring Committees in Clinical Trials
  • Author : Jay Herson
  • Publisher : CRC Press
  • Release : 19 December 2016
GET THIS BOOKData and Safety Monitoring Committees in Clinical Trials

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a

Adaptive and Flexible Clinical Trials

Adaptive and Flexible Clinical Trials
  • Author : Richard Chin
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKAdaptive and Flexible Clinical Trials

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher : Government Printing Office
  • Release : 01 April 2014
GET THIS BOOKRegistries for Evaluating Patient Outcomes

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database