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Contract research and development or...

Gad, Shayne C.

Contract research and development organizationstheir history, selection, and utilization /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Contract research and development organizationsby Shayne C. Gad, Charles B. Spainhour, David G. Serota.
其他題名:	their history, selection, and utilization /
作者:	Gad, Shayne C.
其他作者:	Spainhour, Charles B.
出版者:	Cham :Springer International Publishing :2020.
面頁冊數:	xiii, 519 p. :ill., digital ;24 cm.
Contained By:	Springer Nature eBook
標題:	Research and development contracts.
電子資源:	https://doi.org/10.1007/978-3-030-43073-3
ISBN:	9783030430733$q(electronic bk.)

Contract research and development organizationstheir history, selection, and utilization /
Gad, Shayne C.

Contract research and development organizationstheir history, selection, and utilization /[electronic resource] :by Shayne C. Gad, Charles B. Spainhour, David G. Serota. - Cham :Springer International Publishing :2020. - xiii, 519 p. :ill., digital ;24 cm.

Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index.

ISBN: 9783030430733$q(electronic bk.)

Standard No.: 10.1007/978-3-030-43073-3doiSubjects--Topical Terms:

524205
Research and development contracts.

LC Class. No.: TS171.4 / .G337 2020

Dewey Class. No.: 658.57

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505 0 $a Introduction -- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart -- The Pharmaceutical Development Process & Testing Requirements -- The Medical Device Development Process & Testing Requirements -- Functions and Types of CROs -- Labs in China and India -- Selection of CROs -- Study Directors and PIs -- Nuts and Bolts of Study Performance SCG/CBS -- Electronic Reporting Requirements (SEND & eCTD) -- Study and Project Monitoring -- Contracting, Pricing, and Cost of Works Performed by CROs -- Consultants and their Role -- Building Relationships: Maximizing your return on Expectations with a CRO -- Common Problems and their Solutions -- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists -- K Specialized Services -- L Consultants Known to be In-Practice -- Index.
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