Table of Contents

PART 1: SETTING THE SCENE Introduction: Cutting the Gordian Knot Chapter 1: Aiming for Excellence PART 2: PLANNING: FROM CHAOS TO COSMOS Chapter 2: The Target Product Profile and Its Uses Chapter 3: Planning the Individual Clinical Trial PART 3: THE PRACTICABLE PROTOCOL Chapter 4. Distilling the Essence of the Protocol: The Protocol Synopsis Chapter 5. Redistillation: Eliminating Impurities By Carrying Out Protocol Chapter 6. The Optimal Blend: The approved Synopsis and the Final Protocol PART 4: THE SPONSOR, THE PHYSICIAN AND THE PATIENT; THE ETERNAL CLINICAL TRIAL TRIANGLE Chapter 7: Of Chickens and Eggs: The Sponsors' Dilemma Chapter 8: Clinician or Clinical Trialist: the Physicians' Dilemma Chapter 9: what About the Customer? the Patients' Dilemma PART 5: AND ANOTHER THING... Chapter 10: About Time: Making Meetings Matter Chapter 11: The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor

About the Author

Michael Tansey is the former Senior Vice President, Chief Medical Officer, and Head of Medical Development at Pharmacia Corporation. He currently provides clinical, regulatory, and process improvement advice to pharmaceutical and biotechnology companies.

Reviews

Featured in the Journal of Clinical Research Best Practices, and selected for The First Clinical Research Bookshelf: Essential reading for clinical research professionals.