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Square Pharmaceutical in Bd

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A MANAGEMENT MODEL FOR A PHARMACEUTICAL CONTRACT RESEARCH ORGANIZATION
Submitted by

Yvonne Leonie Jacobs
In fulfillment of the requirements for the degree of Doctor of Philosophy in the Faculty of Economical Science Department of Business Management University of the Free State

Promoter: Prof J A A Lazenby

UNIVERSITY OF THE FREE STATE
31 May 2004

A MANAGEMENT MODEL FOR A PHARMACEUTICAL CONTRACT RESEARCH ORGANIZATION

ACKNOWLEDGEMENTS

It is good to have an end to journey towards, but it is the journey that matters in the end. (Ursula K. le Guin)

I want to thank my promoter Prof Kobus Lazenby for his valued support during this journey, guiding me from almost to utmost; Prof Gina Joubert for making a vision becomes reality; George Sabbagha for his linguistic input; and Linda Potgieter for friendship & advice; FARMOVS-PAREXEL for the opportunity to use the organization as a case study; Family and friends for encouragement; and above all to Him, who have never led me where His grace couldn’t keep me.

Page ii

A MANAGEMENT MODEL FOR A PHARMACEUTICAL CONTRACT RESEARCH ORGANIZATION

TABLE OF CONTENTS
TITLE PAGE ......................................................................................................................... i TABLE OF CONTENTS ................................................................................................... iii GLOSSARY OF ABBREVIATIONS AND DEFINITIONS ............................................. ix

1.

INTRODUCTORY CONCEPTS: REFLECTIONS ON CLINICAL RESEARCH AND DRUG DEVELOPMENT .......... 1

1.1 1.2

INTRODUCTORY: REFLECTIONS ON HISTORY ................................... 1 CONTRACT RESEARCH ORGANIZATIONS AS PART OF THE VALUE-CHAIN IN CLINICAL RESEARCH ....................................... 4

1.2.1 1.2.2 1.3 1.3.1 1.4 1.4.1 1.4.2 1.4.3 1.5 1.5.1 1.5.2 1.6

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