The Selection and Use of Contract Research Organizations
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:
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.
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CHAPTER 2 The Pharmaceutical Development Process
CHAPTER 3 The Medical Device Development Process
CHAPTER 4 Functions and Types of CROs
CHAPTER 5 Selection of CROs
CHAPTER 6 ContractingPricing and Cost of Works Performed by CROs
CHAPTER 7 Monitoring Ongoing Studies and Work
CHAPTER 8 Common Problems and their Solutions
APPENDIX C Analytical Labs
APPENDIX D GMP Contract Facilities
APPENDIX E Formulation
APPENDIX F Dosage Forms
APPENDIX G Clinical Testing
APPENDIX H Regulatory Services
APPENDIX I Contract Laboratory Audit Check List
APPENDIX A Toxicology Labs
APPENDIX B Miscellaneous Labs and Services
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activities Additional Services analysis Analytical animal Audit billion biocompatibility biocompatibility testing Canada Cangene Corp Charles River Laboratories chemical client Clinical Research clinical trials complete conﬁdentiality contract laboratory contractor cost Covance CROs deﬁned deﬁnition difﬁcult documentation dosage form drug evaluation facility ﬁnal report ﬁnding ﬁrst formulation development identiﬁcation industry inspection lab notebooks Manufacture medical device Method validation Midwest Research Institute monitoring nonclinical notebook Ontario operations outsource organization outsourcing package PAREXEL performed Pharma pharmaceutical development pharmacokinetics Phase potential problem procedures Programming project management protocol QA/QC raw data regulated regulatory Research Institute safety samples scientiﬁc signature signiﬁcant SOPs speciﬁc sponsor stability standards storage study director study record sufﬁcient Technologies tion toxicity Toxicology Vendor Location Phone Website X X X X X X X