Clinical Trials Risk Management

Martin Robinson, Simon Cook (Autoren)

Buch | Hardcover

232 Seiten

2005
Crc Press Inc (Verlag)
978-0-8493-3323-1 (ISBN)

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Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk Management explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations.

After building a foundation of basic principles, the authors lead you through specific methods for handling the risks characteristically encountered in clinical trials. Their combined years of experience in pharmaceutical research and development shine through the narrative, making the prose both lively and informative. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

After reading this book, you will know how to:

Prepare a Risk Assessment

Design an Impact-Probability Matrix

Compile a Risk Register

Run a Monte Carlo Simulation

Set up a Project Decision Tree

Plan preventative and contingency actions

The stand-alone chapters provide easy access to topics, while anecdotal and visual examples make them easy to remember. Martin Robinson and Simon Cook deliver a clear interpretation of complex information, thus saving you the time it would take to wade through a lengthier text, adopting a straightforward approach to examining clinical trials from a risk manager's perspective. A practical, readable guide, the book is filled with information that can be put to immediate use to improve current or planned clinical trials.

Martin Robinson, Simon Cook

Definitions and Concepts. Drug Safety and Pharmacovigilance. Types of Risk in Clinical Trials. Risk Identification. Threats and Opportunities. Planning Preventative Strategies. Backup Planning. Tracking Risks. Investigational Site Risk Management. Post Projection Evaluation.

Erscheint lt. Verlag	12.10.2005
Verlagsort	Bosa Roca
Sprache	englisch
Maße	156 x 234 mm
Gewicht	590 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pharmazie
	Naturwissenschaften ► Biologie
	Technik
	Wirtschaft ► Betriebswirtschaft / Management ► Unternehmensführung / Management
ISBN-10	0-8493-3323-7 / 0849333237
ISBN-13	978-0-8493-3323-1 / 9780849333231
Zustand	Neuware