Clinical Trials Risk Management

Regular price €223.20
A01=Martin Robinson
A01=Simon Cook
ADME
advanced clinical risk assessment techniques
Animal Studies
Author_Martin Robinson
Author_Simon Cook
Category=KJMD
CFR
clinical trial methodology
CRF Page
critical
eq_bestseller
eq_business-finance-law
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
GMP Quality
Ich
impact probability matrix
IND Application
Influenza Study
Initiation Visit
investigator
Investigator Site
MAA
manager
Monte Carlo simulation
patient
Patient Recruitment
pharmacovigilance strategies
plan
Plasma Concentration
Post-project Evaluation
Potential Investigator
prevention
project
project decision tree
recruitment
register
Repeat Dose Toxicity Studies
Risk Assessment
Risk Management
Risk Prevention
Risk Prevention Plan
Risk Register
risk tracking systems
Site Selection
sites
Trial Timeline
Unacceptable Safety Profile
VSD

Product details

  • ISBN 9780849333231
  • Weight: 590g
  • Dimensions: 156 x 234mm
  • Publication Date: 12 Oct 2005
  • Publisher: Taylor & Francis Inc
  • Publication City/Country: US
  • Product Form: Hardback
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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.