Download or read book Outsourcing Clinical Research Projects written by David Bryde and published by Inst of Clinical Research. This book was released on 2007 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor.
Download or read book Outsourcing Clinical Development written by Jane Baguley and published by CRC Press. This book was released on 2016-05-13 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Putting Contract Research Organisations on the Radar written by SOMO Research and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is a trend for pharmaceutical companies to contract third parties to conduct their clinical trials in order to test their drugs. This trend is referred to as 'outsourcing', and the companies that carry out the work are called 'contract research organisations' (CROs). In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle-income countries. This trend is called 'offshoring'. It is widely agreed that the offshoring of clinical trials to these regions should be scrutinised from an ethical perspective because of the vulnerability of the trial population. What happens when offshoring is combined with outsourcing? Do additional ethical risks arise when clinical trials are contracted out? Virtually all pharmaceutical companies publicly declare that they test their drugs in accordance with the highest ethical guidelines, such as the Declaration of Helsinki. But how do pharmaceutical companies safeguard their commitments when they outsource clinical trial activities to CROs in poor regions? These are the central questions that are addressed in this report. The report is based on research conducted in India, Argentina, Brazil and Peru, and combined with interviews with pharmaceutical companies and clinical trial experts. The research experiences demonstrate that the pharmaceutical sector is generally not transparent, which hinders the definitive answering of the research questions. Nevertheless, the secondary and interview data collected in India, Argentina, Brazil and Peru provides some valuable insights into the way the CRO sector is developing in these countries. Furthermore, the report demonstrates that pharmaceutical companies have elaborate systems in place to manage their supply chain responsibility, although their functioning can not be independently verified. In addition, experts, authorities and clinical trial practitioners in the selected non-traditional trial regions still expressed grave concerns about the implementation of clinical trials in these countries.
Download or read book Contract Research and Development Organizations written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2011-08-04 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.
Download or read book Pharmaceutical Outsourcing Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!
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 Contract Research and Development Organizations Their History Selection and Utilization written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-07-17 with total page 515 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.
Download or read book Pharmaceutical Eclinical Trials Outsourcing written by MaryAnne F. Rizk and published by . This book was released on 2012 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book When Experiments Travel written by Adriana Petryna and published by Princeton University Press. This book was released on 2009-04-27 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.
Download or read book Clinical Trials in Latin America Where Ethics and Business Clash written by Nuria Homedes and published by Springer Science & Business Media. This book was released on 2013-11-29 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.
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 Controversies in Latin American Bioethics written by Eduardo Rivera-López and published by Springer. This book was released on 2019-06-19 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a first rate selection of academic articles on Latin American bioethics. It covers different issues, such as vulnerability, abortion, biomedical research with human subjects, environment, exploitation, commodification, reproductive medicine, among others. Latin American bioethics has been, to an important extent, parochial and unable to meet stringent international standards of rational philosophical discussion. The new generations of bioethicists are changing this situation, and this book demonstrates that change. All articles are written from the perspective of Latin American scholars from several disciplines such as philosophy and law. Working with the tools of analytical philosophy and jurisprudence, this book defends views with rational argument, and opening for pluralistic discussion.
Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH AND THE LAW The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including: standards and duty of care conflicts of interest establishing clinical trials informed consent research contracts the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
Download or read book Clinical Research written by Robert D. Toto and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publish clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, investigational new drug and device applications, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. The authors provide instruction on how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on collection, quality control, and analysis of data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature.
Download or read book A National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2010-07-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Download or read book Outsourcing Clinical Trials to India written by Heather Faulds and published by . This book was released on 2005 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trial Project Management written by Martin Robinson and published by Inst of Clinical Research. This book was released on 2008 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
