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.