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.
Оглавление
Alexey Levashov. Project Management in Clinical Trials
List of Abbreviations
Introduction
Philosophy of project management in clinical trials
Project targets
Scope
Quality
Timelines
Cost
Building blocks of project management in clinical trials
Planning
Organizing. Patient recruitment
Enrollment boosting measures
Patient retention
Protocol Deviations
Adverse events
Data cleaning
Notes to File
Study team management
Self-organization
Motivating
Controlling
Connecting processes
Communication
Decision making
Leadership
Building project management in your organization
Risk management
Vendor management
Managerial emotional burning out
Different styles of management
Conclusion
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AE – Adverse Event
CRA – Clinical Research Associate
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And please add a high turnover rate to all these factors. As a result, such companies do not have what I call corporate memory. In the middle of a trial they do not know what key decisions have been made by them themselves or their predecessors and are very often prone to challenge them, which is not always a good idea in an ongoing trial.
They are constantly overloaded and distracted. It is hard for them to observe timelines for study-related documents like plans, budgets, and so on. One of the most frequent requests you can hear from them begins with the words “Could you please re-send?..” – an e-mail, a document, and so on.
