The selection and use of contract research organizations : a guide for the pharmaceutical and medical device industries

"Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your essential guide to choosing the best provider. A history of the CRO industry, audit checklists, and overviews of both the pharmaceutical and medical device development processes create a comprehensive overview of how to successfully select and manage a CRO for your project. The book also discusses:Guidance for selection, protocol and contract development, project management and monitoring of workCommon pitfalls and problems - how to avoid them, and how to solve them if they do occurHow to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and timely productionPrototype forms and templates for increasing coordination between multiple working groupsA series of appendices covering hundreds of prominent service providers worldwide, including contact informationOperative regulations and lawsIn addition to providing fundamental guidance on how to select and manage a CRO in the product development process, this reference also includes a set of eight databases that contain contact information for prominent service providers in North America, Europe, and Japan, and overviews of services they offer. It is a complete resource for professionals in biotechnology, and pharmaceutical and medical device development."--Provided by publisher

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your essential guide to choosing the best provider.

A history of the CRO industry, audit checklists, and overviews of both the pharmaceutical and medical device development processes create a comprehensive overview of how to successfully select and manage a CRO for your project. The book also discusses:

Guidance for selection, protocol and contract development, project management and monitoring of work

Common pitfalls and problems - how to avoid them, and how to solve them if they do occur

How to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining quality and timely production

Prototype forms and templates for increasing coordination between multiple working groups

A series of appendices covering hundreds of prominent service providers worldwide, including contact information

Operative regulations and laws

In addition to providing fundamental guidance on how to select and manage a CRO in the product development process, this reference also includes a set of eight databases that contain contact information for prominent service providers in North America, Europe, and Japan, and overviews of services they offer. It is a complete resource for professionals in biotechnology, and pharmaceutical and medical device development.

Book Cover......Page 1 Title......Page 4 Copyright......Page 5 Dedication......Page 6 Contents......Page 8 Preface......Page 10 CHAPTER 1 Introduction......Page 12 CHAPTER 2 The Pharmaceutical Development Process......Page 42 CHAPTER 3 The Medical Device Development Process......Page 56 CHAPTER 4 Functions and Types of CROs......Page 72 CHAPTER 5 Selection of CROs......Page 82 CHAPTER 6 Contracting,Pricing, and Cost of Works Performed by CROs......Page 104 CHAPTER 7 Monitoring Ongoing Studies and Work......Page 118 CHAPTER 8 Common Problems and their Solutions......Page 124 APPENDIX A Toxicology Labs......Page 132 APPENDIX B Miscellaneous Labs and Services......Page 140 APPENDIX C Analytical Labs......Page 146 APPENDIX D GMP Contract Facilities......Page 152 APPENDIX E Formulation......Page 158 APPENDIX F Dosage Forms......Page 162 APPENDIX G Clinical Testing......Page 166 APPENDIX H Regulatory Services......Page 176 APPENDIX I Contract Laboratory Audit Check List......Page 182 Index......Page 188 The research driven components of the global health care industry represent an enormous economic and societal force in the world, and are composed of an incredibly diverse set of component organizations. This book is a guide for personnel in the pharmaceutical and medical device industries. It will give you the peace of mind that you've thought through all the angles and made well-informed decisions.