LEADER 04925nam 22006135 450 001 9910416106103321 005 20220408093110.0 010 $a3-030-43073-1 024 7 $a10.1007/978-3-030-43073-3 035 $a(CKB)4100000011354712 035 $a(DE-He213)978-3-030-43073-3 035 $a(MiAaPQ)EBC6273753 035 $a(PPN)259391670 035 $a(EXLCZ)994100000011354712 100 $a20200717d2020 u| 0 101 0 $aeng 135 $aurnn#008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aContract Research and Development Organizations-Their History, Selection, and Utilization /$fby Shayne C. Gad, Charles B. Spainhour, David G. Serota 205 $a1st ed. 2020. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2020. 215 $a1 online resource (XIII, 519 p. 19 illus., 1 illus. in color.) 300 $aIncludes index. 311 $a3-030-43072-3 327 $aIntroduction -- 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. . 330 $aThis volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements ? SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs ? where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities ? and for auditing studies and projects at such facilities ? are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update. 606 $aPharmacology 606 $aPharmacy 606 $aPharmacology/Toxicology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21007 606 $aPharmacy$3https://scigraph.springernature.com/ontologies/product-market-codes/F00008 606 $aLiteratura científica$2thub 606 $aInvestigació$2thub 606 $aContractes de recerca i desenvolupament$2thub 608 $aLlibres electrònics$2thub 615 0$aPharmacology. 615 0$aPharmacy. 615 14$aPharmacology/Toxicology. 615 24$aPharmacy. 615 7$aLiteratura científica 615 7$aInvestigació 615 7$aContractes de recerca i desenvolupament 676 $a658.57 700 $aGad$b Shayne C$4aut$4http://id.loc.gov/vocabulary/relators/aut$096171 702 $aSpainhour$b Charles B$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aSerota$b David G$4aut$4http://id.loc.gov/vocabulary/relators/aut 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910416106103321 996 $aContract Research and Development Organizations-Their History, Selection, and Utilization$92495857 997 $aUNINA