Download or read book 12 Essential Activities of Clinical Trial Project Management written by T. C. George, Dr. and published by CreateSpace. This book was released on 2014-11-01 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Project Management in Clinical Trials written by Alexey Levashov and published by Litres. This book was released on 2021-05-25 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Clinical Trial Project Management written by Ashok Kumar Peepliwal and published by Elsevier. This book was released on 2023-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Project Management of Clinical Trials written by Richard Chamberlain and published by Xlibris Corporation. This book was released on 2019-09-24 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book An Overview of Clinical Trial Operation written by Shibadas Biswal and published by . This book was released on 2017-12-19 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a must-read for students and professionals for a broad understanding of the entire process of clinical trial operation. In the second edition released in December 2017, we have added several new topics of interest taking the total count to 112. At the moment, a clinical trial is the most relevant method at our disposal to explore and establish safety/efficacy of a new medicine. It is the fundamental basis of clinical development programs of healthcare products. Clinical research has opened up several new career choices. Graduates in medicine, pharmacy, and other life sciences now have the option to work as investigators, scientists, project managers, data managers, monitors, study coordinators, regulatory affairs managers, and so on. Many of these positions have specialized and focused responsibilities in the industry setting. Considering the highly complex environment of clinical research, a broad overview is indispensable for effective collaboration.This book has been written for life science graduates aspiring to work in clinical research industry or clinical research professionals without considerable experience in trial operation. It would also be useful for professionals with focused responsibilities to broaden understanding of the entire gamut of trial operation. As fundamental approach is independent of nature of the investigational product (e.g. drug, device, vaccine or diagnostic agent), we are hopeful of its wider usefulness to the entire healthcare industry.The objective is to provide a broad outline of key activities, principles, roles, and responsibilities without getting into procedural details. Most organizations involved in clinical research have defined processes and procedures to carry out specific responsibilities relevant to their business. Hence, the discussion is purposefully limited to an overview to keep it concise yet informative. Discussion in each topic covers the background, operational overview, and usual challenges.Frequently used terminology has been introduced in the context of specific topics to induce familiarity. The book has been organized into several topics from the perspective of a project manager driving an entire trial. Organization of topics is according to the flow of trial operation from conception to the end. At the outset, the context of different trials according to phases of drug development has been introduced. Subsequent topics are on planning, setup, execution, and closeout in a sequential manner. Towards the end, the topics are on few general aspects of trial operation.This book has been written based on our practical experience, as well as regulatory guidance and other freely accessible literature. Good clinical practice (GCP) lays down the fundamental guiding principles for trial operation. Familiarity with any GCP guidance is highly recommended for the best outcome from this book.

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Download or read book Principles and Practice of Clinical Trial Medicine written by Richard Chin and published by Elsevier. This book was released on 2008-07-25 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Download or read book Monte Carlo Simulation for the Pharmaceutical Industry written by Mark Chang and published by CRC Press. This book was released on 2010-09-29 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and metho

Download or read book Documentation of Clinical Trial Monitoring written by Edyta Niebrzegowska and published by Troubador Publishing Ltd. This book was released on 2019-02-28 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.

Download or read book Project Management for the Pharmaceutical Industry written by Laura Brown and published by Gower Publishing, Ltd.. This book was released on 2011 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written firmly from the perspective of the pharmaceutical industry, Laura Brown and Tony Grundy offer a guide to the tools and techniques of project management. They cover both the technical and human aspects of project management to provide clinical research, drug development and quality assurance managers or directors with a must-have reference.

Download or read book Basic Methods Handbook for Clinical Orthopaedic Research written by Volker Musahl and published by Springer. This book was released on 2019-02-01 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to meet the needs of both novice and senior researchers in Orthopaedics by providing the essential, clinically relevant knowledge on research methodology that is sometimes overlooked during training. Readers will find a wealth of easy-to-understand information on all relevant aspects, from protocol design, the fundamentals of statistics, and the use of computer-based tools through to the performance of clinical studies with different levels of evidence, multicenter studies, systematic reviews, meta-analyses, and economic health care studies. A key feature is a series of typical case examples that will facilitate use of the volume as a handbook for most common research approaches and study types. Younger researchers will also appreciate the guidance on preparation of abstracts, poster and paper presentations, grant applications, and publications. The authors are internationally renowned orthopaedic surgeons with extensive research experience and the book is published in collaboration with ISAKOS.

Download or read book Case Studies in Innovative Clinical Trials written by Kristine Broglio and published by CRC Press. This book was released on 2023-11-27 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design. Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies. Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered. A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own.

Download or read book Anti tumor Activity of Cytotoxic Immune Cells Basic Research and Clinical Perspectives written by Malgorzata Firczuk and published by Frontiers Media SA. This book was released on 2024-05-24 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cytotoxic T lymphocytes (CTL) and natural killer (NK) cells are powerful effectors of antitumor immunity. CTL recognize tumor antigens presented by human leukocyte antigen (HLA) molecules with antigen-specific T cell receptors (TCR) and are the key effector cells of the adaptive immune response. In contrast, NK cells lack antigen-specific receptors and are regulated by the balance of signals from activating and inhibitory receptors. These two types of cells cooperate and complement each other in eliciting host immune response to cancer and mediating immune surveillance. Moreover, these cells play a crucial role in antitumor immunotherapy, including monoclonal antibodies (mAbs), bispecific T cell engagers (BiTe), as well as adoptive transfer of chimeric antigen receptor (CAR)-modified cytotoxic cells.

Download or read book Project Management for Drug Developers written by Joseph P. Stalder and published by CRC Press. This book was released on 2022-12-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Biomedical Index to PHS supported Research pt A Subject access A H written by and published by . This book was released on 1992 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt: