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There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics. Получить ссылку |
Terry's Trials and Triumphs
Автор: Oxley James Macdonald
Год издания:
Project Management in Clinical Trials
Автор: Alexey Levashov
Год издания:
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.
Staying the Course as a CIO. How to Overcome the Trials and Challenges of IT Leadership
Автор: Jonathan Mitchell
Год издания:
STAYING THE COURSE AS A CIO: HOW TO OVERCOME THE TRIALS AND CHALLENGES OF IT LEADERSHIP The shelf-life of a Chief Information Officer can be shockingly short. Few survive in post for more than a few years. More often each falls prey to insurmountable problems and their careers come to a sharp and ignominious end. In this book, a global CIO with over thirty years of experience in major corporations examines the main reasons why this happens. Readers will understand which types of issue can cause problems for an IT Leader and more importantly, they will learn strategies of how these problems can be minimized or even avoided. IT is often seen a technical backwater, but it is a discipline which has the capability to add massive value to an organisation whether it is in the private or the public sector – provided of course it has the right leadership doing the right things. Aspiring IT Leaders will need to deal with a common set of recurring trials and challenges. These include: · Overcoming the challenge of managing diverse and conflicting stakeholders · How to deal with large and complex projects · Making sense of software and how to handle the rapidly changing technology landscape · Knowing when to outsource and how to get the best out of an outsourcing partner · Harnessing the intellectual power of consultants to help you meet your goals · And last but not least, how to develop a set of strategies that are aligned with your corporate goals and then make sure your resources are properly targetted so that the IT function generates maximum positive impact for the enterprise. For IT professionals looking to fully integrate their function into the enterprise, 'Staying the Course as a CIO’ is a valuable source of practical advice, all based on real experience.
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