The Essential Guide to Clinical Research and Pharma Industry

The Essential Guide to Clinical Research and Pharma Industry
Author: Poorva Jain
Publisher: Independently Published
Total Pages: 0
Release: 2024-01-19
Genre: Study Aids
ISBN:

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Unlock your potential in the world of drug discovery with this comprehensive handbook. Demystify complex concepts, explore key departments, and land your dream job in the dynamic pharmaceutical industry. Tired of jargon and confusing acronyms? This guide cuts through the clutter, explaining clinical research and pharma processes in clear, concise language. Dive into departments like Clinical Data Management, Clinical Research Associate, Clinical Research Coordinator, Medical Writing, Regulatory Affairs, and Clinical Operations, understanding how they work together to transform molecules into life-saving drugs. Real-world examples and vivid analogies bring science to life, making even the most technical aspects easy to grasp. More than just theory, this book is your career compass: Explore diverse job options: From Clinical Research Associates to Medical Coders, discover a variety of rewarding roles within the industry. Master the skills you need: Each department breakdown highlights essential qualifications and expertise, ensuring you're prepared for every step. Ace your interviews: Objective knowledge assessments and practical tips boost your confidence and help you shine in front of hiring managers. Whether you're a fresh graduate, a career changer, or simply curious about the inner workings of the pharma world, this book is your essential guide. Become a superhero in the fight for better health, one informative page at a time.

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
Author: JoAnn Pfeiffer
Publisher: CRC Press
Total Pages: 292
Release: 2017-05-18
Genre: Mathematics
ISBN: 1315299771

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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

The Comprehensive Guide To Clinical Research

The Comprehensive Guide To Clinical Research
Author: Chris Sauber
Publisher: Independently Published
Total Pages: 218
Release: 2019-04-21
Genre:
ISBN: 9781090349521

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Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

A Guide to Clinical Drug Research

A Guide to Clinical Drug Research
Author: A. Cohen
Publisher: Springer Science & Business Media
Total Pages: 205
Release: 2013-04-17
Genre: Medical
ISBN: 940158463X

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A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
Author: J. Rick Turner
Publisher:
Total Pages: 114
Release: 2011-09-01
Genre: Clinical trials
ISBN: 9780615507675

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Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
Author: Allan Hackshaw
Publisher: John Wiley & Sons
Total Pages: 184
Release: 2011-09-07
Genre: Medical
ISBN: 1444356666

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Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Handbook of Clinical Research

Handbook of Clinical Research
Author: Julia Lloyd
Publisher:
Total Pages: 491
Release: 1994
Genre: Clinical trials
ISBN: 9780443050046

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A comprehensive and practical guide covering the multidisciplinary aspects of clinical drug research. There are multi-author contributions from both scientists and clinicians from pharmaceutical and medical professions, giving practical information and informed comment on benefits and pitfalls.

Valuing Pharmaceutical Companies

Valuing Pharmaceutical Companies
Author: Karen Beynon
Publisher: Woodhead Publishing
Total Pages: 188
Release: 2000-06-19
Genre: Business & Economics
ISBN: 9781855734586

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The pharmaceutical sector offers some of the most exciting financial and business opportunities today. This essential and practical guide gives you all the tools you need to assess such opportunities. The second edition of the respected Pharmaceutical Equities, it has been thoroughly revised and updated to reflect the changes, especially in life sciences, since the first edition. The book is international in outlook, and explains the rules of the game not just for wise investing, but also for understanding how this uniquely complex and highly regulated business works. The authors explain: HOW to evaluate the technology and research and development, as well as the sales potential of ensuing products WHAT key issues will affect and influence companies in the next few years HOW to balance potential high returns on breakthrough products against accompanying risks The book begins with a look at the global pharmaceutical industry, from its history to the structure of present day companies. The second part explores how to analyse and value pharmaceutical and biotechnology companies. The final part deals with trading itself and looks at share price movement and the main equity markets throughout the world. Both practical and comprehensive, this handbook will be essential reading for investors, analysers and corporate planners - and is the ONLY book which will show you how to actually value pharmaceutical companies.

The Investigator's Guide to Clinical Research

The Investigator's Guide to Clinical Research
Author: David Ginsberg
Publisher:
Total Pages: 324
Release: 2002
Genre: Medical
ISBN:

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The Investigator's Guide to Clinical Research is a step-by-step manual filled with tips, instructions and insights for investigators - novice and experienced - and health professionals involved in conducting clinical research. Along with updated sections, charts and statistics, the 3rd edition includes a detailed look at investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. A new appendix includes valuable lists of company contacts and additional resources. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include...An overview of the clinical development process; A review of regulatory requirements; How to set up and manage a research center; How to effectively and efficiently conduct clinical trials and How to identify and secure clinical grant opportunities.

Outsourcing Clinical Development

Outsourcing Clinical Development
Author: Jane Baguley
Publisher: CRC Press
Total Pages: 193
Release: 2016-05-13
Genre: Social Science
ISBN: 1317084586

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The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.