Outsourcing in Clinical Drug Development

by Drucker; Roy

• ISBN13: 9781574911121
• ISBN10: 1574911120
• Edition: 1st
• Format: Hardcover
• Copyright: 2002-08-15
• Publisher: CRC Press

Summary

Outsourcing in Clinical Drug Development is your complete guide to the drug development outsourcing relationship. Editors Roy Drucker and Graham Hughes have assembled an expert group of specialists to help you explore the various services offered by outsourcing suppliers and to guide you through your outsourcing options. The book even includes a series of chapters devoted to helping you sort through the legal, ethical, financial, organizational, and practical issues involved in a wide range of outsourcing relationships. Whether you are just exploring the possibility of outsourcing or whether you are already involved in long-term strategic outsourcing partnerships, this book is an invaluable resource. Sponsor companies and CROs alike will appreciate the industry-wide analysis and practical, how-to advice, including helpful charts and checklists. Book jacket.

Table of Contents

Preface	ix
Suppliers to Healthcare R&D	1	(20)
Graham Hughes
Suppliers to Healthcare R&D	2	(2)
Types of Suppliers	4	(4)
Phase I Suppliers	8	(2)
Preclinical and Toxicology (PC&T) Suppliers	10	(3)
Pharmaceutical Development Suppliers	13	(1)
Clinical Pathology, Chemical Analysis, and Assay Suppliers	14	(2)
Postregistration (PR) Studies and Phase IV (PR Studies) Suppliers	16	(5)
The Sourcing Decision	21	(14)
Roy Drucker
Supplier Analysis by Sector	22	(3)
Benchmarking and Core Competences	25	(1)
Drivers to the Sourcing Choice	26	(3)
Organization for the Sourcing Decision	29	(1)
Evolving Pharmaceutical Sourcing Teams That Work Well	30	(1)
Critical Evaluation of the Pharmaceutical Purchasing Function	30	(1)
Create a Cohesive, Coherent, Decision-Making Structure	30	(1)
Nature of the Decision and Supplier Issues	31	(1)
Decision and Selection	31	(1)
Create Resonant Value Chains Reflecting Internal Versus Outsourced Options	32	(1)
Critical Appraisal of Contractual Basis	32	(1)
Conclusion	32	(3)
Supplier Identification, Evaluation, and Selection	35	(16)
Tim Wright
Establishing a Framework for Identifying, Selecting, and Evaluating CROs	36	(1)
Stage One: Identifying, Evaluating, and Selecting CROs for Individual Projects	36	(9)
Stage Two: Developing the Supplier Base	45	(3)
Stage Three: Developing Long-Term Partnerships	48	(2)
Conclusions	50	(1)
Financial and Organizational Outsourcing Considerations	51	(8)
Nadia Turner
Chris Keep
Financial Considerations	52	(4)
Organizational Considerations	56	(3)
Clinical Research Contracting---A Legal Perspective	59	(14)
Paul Ranson
General Legal Issues in Outsourcing	60	(1)
Preparation for Outsourcing and Contractual Structure	61	(2)
Precontractual Documentation	63	(2)
Common Terms in a Contract Research Agreement	65	(4)
Change Management	69	(1)
Employment Issues	70	(1)
Conclusions and the Future	71	(2)
Ethical Considerations in Outsourced Clinical Trials	73	(14)
Richard Ashcroft
Ethical Guidelines in Clinical Research	74	(1)
Ethical Principles	75	(1)
Ethical Values in Research	76	(2)
Applications to Outsourced Clinical Research	78	(5)
Conclusion	83	(4)
Avoiding and Managing Conflict in Outsourcing Clinical Research	87	(12)
Lucien Steru
The Conflict	88	(2)
Background Facilitating Conflicts	90	(2)
Talking About Money	92	(2)
Diagnostic and Preventive Behaviors in an Emerging Conflict	94	(3)
Corporate Prevention of Conflicts	97	(1)
Conclusion	98	(1)
The Role of Site Management Organizations	99	(22)
Rakesh Nath
Game Theory: SMOs and Their Interaction with Other Outsourcing Players	100	(13)
Relationships	113	(8)
Clinical Trial Supplies---The Vital Link	121	(16)
Patricia Lobo
What Do We Mean by Clinical Trial Supplies?	121	(1)
Outsourcing	122	(1)
Clinical Trial Supplies Activities	123	(5)
The Market for Outsourcing Clinical Trial Supplies Manufacturing and Packing	128	(1)
What Is a CTSO?	128	(1)
Growing the CTS Business	129	(3)
Pharmaceutical Companies' Opinion Survey	132	(2)
Forecasting CTS Business---The Challenge	134	(3)
Contracting Out Laboratory Analysis	137	(14)
Ann Speaight
Assessing a Laboratory	141	(6)
Costs and Contracts	147	(2)
Certification of Laboratories	149	(1)
Conclusion	150	(1)
Contracting Data Management and Statistical Services	151	(18)
Jacqui Spencer
The Pharmaceutical Companies' Viewpoint	153	(1)
History of Outsourcing Clinical Data Management	153	(2)
Types of CROs for Clinical Data Management	155	(4)
The Selection of CROs for Clinical Data Management	159	(5)
Future Trends: Information Technology	164	(2)
Conclusions	166	(3)
Global Clinical Trials: The Cultural Challenge	169	(16)
Madeline J. Ducate
Global Programs Versus Global Studies	170	(2)
Enrollment Considerations	172	(3)
Patient Follow-Up/Retention	175	(1)
Medical Practices and Healthcare Equipment	175	(3)
Investigational Fees	178	(1)
Central Randomization and Medical Hotlines	179	(2)
Central and Local Laboratories	181	(1)
Pharmacies	182	(1)
Importing Investigational Products	182	(1)
A Case Study	183	(2)
Outsourcing and the Use of Contract Quality Assurance	185	(12)
Nigel J. Dent
Consultancy Services	186	(3)
Consultants and Their Use by Companies	189	(1)
Choosing a Consultant	190	(1)
Pitfalls and Benefits of Using Consultants	191	(6)
Contracting Out Regulatory Projects to a Regulatory CRO	197	(16)
Gillian Gregory
John Glasby
Choosing a Regulatory CRO	198	(4)
Why Use a Regulatory CRO at All?	202	(1)
Evaluating Regulatory Consultants	203	(2)
Selecting the Regulatory Consultant	205	(3)
How to Judge a CRO	208	(1)
Tasks in the Regulatory Area	209	(1)
When the Project Is Running	209	(1)
Channels of Communication and Contracts	210	(1)
Conclusion	211	(2)
Trends in Pharmaceutical Development Outsourcing	213	(22)
Jeffrey S. Rudolph
Joseph S. Tempio
Background	214	(3)
Future Drivers	217	(4)
Outsourcing Industry---Maturation	221	(2)
Discovery---Outsourcing with a Twist and Flair!	223	(2)
Development---Coping with Quality and Quantity	225	(1)
External Environment Nonpharmaceutical Outsourcing/Best Practice	226	(4)
Central Sourcing Group/Chief Sourcing Officer	230	(2)
Conclusions	232	(3)
APPENDIX: AN OVERVIEW OF THE DRUG DEVELOPMENT PROCESS	235	(6)
Drug Discovery and Screening	235	(1)
Animal Studies	236	(1)
Clinical Development	237	(1)
Pharmaceutical Development	238	(1)
Time Frames and Costs	238	(3)
Contributors	241	(8)
Index	249