1021:
1591:
1969:
1541:
159:(5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).
130:
120:
Organizations who have had success in working with a particular CRO in a particular context (e.g. therapeutic area) might be tempted or encouraged to expand their engagement with that CRO into other, unrelated areas; however, caution is required as CROs are always seeking to expand their experience
108:
retains responsibility for the quality of the CRO's work. CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to
185:
As of 2013, there were over 1,100 CROs in the world, despite continued trends toward consolidation. Many CROs have been acquired while others have gone out of business. The industry is fragmented, with the top 10 companies controlling 56% of the market in 2008 and 55% in 2009. In 2018 global CRO
1009:
93:, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the
148:(5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement
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has been delegated to the CRO. 2021 saw a major update to US FDA regulations related to providing the agency with information about CROs and how they "comply with FDA regulations".
2076:
1954:
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137:
services as: "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."
1557:
1316:
200:
As of 2016, there was a 15.5% increase in R&D spending from 2015 to 2020. The list of contract research organizations includes the following notable companies worldwide:
1364:
1998:
1944:
1321:
165:(5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.
1919:
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1025:
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1924:
1883:
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1331:
521:
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186:
market stood at $ 38,396.4 mln. and is projected to reach $ 90,926.3 mln. by the end of 2026, exhibiting a CAGR of 11.4% in the forecast period.
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1326:
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133:, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to
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1857:
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1737:
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265:
173:
published in 2013 also speaks to the responsibility of the sponsor to oversee work of the CRO, including the circumstance where
162:(5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
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2036:
1369:
1341:
174:
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104:
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. However, the
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110:
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228:
131:
International
Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
121:
and success in one area cannot reliably predict success in unrelated areas that might be new to the organization.
2121:
1163:
908:
822:
651:
114:
98:
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448:
International
Council on Harmonisation good clinical practice, 66 ppp, amended Nov 2016, accessed 30 Jan 2018
2014:
1727:
1627:
1259:
43:
634:"Charles River Laboratories Announces Fourth-Quarter and Full-Year 2020 Results and Provides 2021 Guidance"
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90:
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827:
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376:
190:
79:
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149:
75:
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17:
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117:
marketing approval, without the drug sponsor having to maintain a staff for these services.
1188:
1138:
464:
431:
337:
153:
67:
580:"IQVIA Reports Fourth-Quarter and Full-Year 2020 Results, Raises Full-Year 2021 Guidance"
562:"Labcorp Announces 2020 Fourth Quarter and Full Year Results and Provides 2021 Guidance"
58:
on a contract basis. A CRO may provide such services as biopharmaceutical development,
1842:
1784:
1526:
1148:
1071:
1020:
134:
105:
59:
51:
477:
The Top 10 Contract
Research Organizations -Positioning, performance and SWOT analyses
85:
CROs are designed to reduce costs for companies developing new medicines and drugs in
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1983:
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817:
222:
47:
31:
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1209:
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86:
682:
423:
1143:
1081:
888:
837:
246:
55:
296:"Contract Research Organizations: Key Partners In The Drug Development Journey"
1824:
1423:
1264:
812:
330:
1501:
1158:
1113:
1086:
913:
858:
853:
802:
216:
670:"Medpace Holdings, Inc. Reports Fourth Quarter and Full Year 2020 Results"
1637:
1224:
1128:
1098:
898:
873:
767:
752:
234:
1274:
1244:
1178:
1118:
966:
956:
883:
878:
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782:
252:
240:
204:
1279:
1239:
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742:
170:
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1312:
European
Directorate for the Quality of Medicines & HealthCare
1254:
1133:
1076:
940:
928:
863:
777:
544:"Clinical Outsourcing Market To See Continued Growth Through 2020"
210:
1380:
European
Federation of Pharmaceutical Industries and Associations
616:"Syneos Health Reports Fourth Quarter and Full Year 2020 Results"
1642:
1987:
1561:
1026:
Pharmaceutical and biotechnology industry in the United
Kingdom
991:
686:
490:"The CRO Market Outlook!publisher =globalbusinessinsights.com"
350:
94:
1507:
European and
Developing Countries Clinical Trials Partnership
1863:
List of pharmaceutical manufacturers in the United
Kingdom
140:
It further details the sponsor's responsibilities in its
652:"ICON Reports Fourth Quarter and Full Year 2020 Results"
458:"CRO Industry Could See More Consolidation, Experts Say"
383:(Guest column). Pennsylvania, United States: VertMarkets
598:"PPD Reports Fourth Quarter and Full Year 2020 Results"
522:"Contract Research Organizations (CRO) services market"
467:
outsourcing-pharma.com, 2013-06-20 Retrieved 2013-09-24
1853:
List of off-label promotion pharmaceutical settlements
1909:
1871:
1835:
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1317:
Medicines and
Healthcare products Regulatory Agency
1292:
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720:
1365:Association of the British Pharmaceutical Industry
375:Sather, Sandra; Lawyer, Jennifer (30 June 2022).
340:, Association of Clinical Research Organizations.
321:, Association of Clinical Research Organizations.
1517:List of world's largest pharmaceutical companies
1322:National Collaborating Centre for Mental Health
1999:
1573:
1522:Pharmaceutical Services Negotiating Committee
1395:Royal Pharmaceutical Society of Great Britain
1003:
698:
42:) is a company that provides support to the
8:
1595:Pharmaceutical industry in the United States
54:industries in the form of research services
2006:
1992:
1984:
1848:List of largest pharmaceutical settlements
1580:
1566:
1558:
1332:Pharmaceutical Society of Northern Ireland
1056:
1010:
996:
988:
705:
691:
683:
524:. fortunebusinessinsights.com. 2019-07-02
27:Company that is paid to provide research
1439:British National Formulary for Children
404:"Contract Research Organizations (CRO)"
286:
1327:Pharmaceutical Price Regulation Scheme
1460:Monthly Index of Medical Specialities
441:
439:
7:
1453:Journal of Pharmacy and Pharmacology
1375:European Federation of Biotechnology
370:
368:
366:
364:
1760:Pharmaceutical sales representative
1037:Manufacturing in the United Kingdom
271:Contract manufacturing organization
1884:Pharmaceutical industry by country
1793:The Truth About the Drug Companies
1400:Worshipful Society of Apothecaries
1385:Faculty of Pharmaceutical Medicine
763:George Institute for Global Health
25:
479:bioportfolio.com, 5 February 2010
2088:List of pharmaceutical companies
1968:
1967:
1858:List of pharmaceutical companies
1702:American Pharmacists Association
1589:
1540:
1539:
1390:Pharmacists' Defence Association
1347:Veterinary Medicines Directorate
1019:
351:"Contract Research Organization"
266:List of pharmaceutical companies
62:development, commercialization,
2107:Contract research organizations
1370:Chemical Industries Association
1723:Contract research organization
1337:General Pharmaceutical Council
714:Contract research organization
542:Ed Miseta (11 February 2016).
125:Definition, regulatory aspects
36:contract research organization
18:Clinical research organization
1:
1342:Scottish Medicines Consortium
1302:Commission on Human Medicines
1220:Cambridge Antibody Technology
1042:Economy of the United Kingdom
446:E6(R2) Good Clinical Practice
1686:Food and Drug Administration
1446:British Pharmaceutical Codex
622:(Press release). 2021-02-18.
1777:The Billion-Dollar Molecule
1718:Clinical research associate
2143:
1475:The Pharmaceutical Journal
1432:British National Formulary
847:Clinical and Healthcare IT
738:Charles River Laboratories
733:Cancer Trials Support Unit
377:"CRO Oversight Essentials"
229:Charles River Laboratories
213:($ 11.35B revenue in 2020)
207:($ 14.00B revenue in 2020)
196:Top CROs by annual revenue
188:
2085:
2022:
1965:
1916:Pharmaceutical companies
1535:
1032:
909:Tata Consultancy Services
823:WIL Research Laboratories
294:Nick Lucas (2021-04-09).
255:($ 0.92B revenue in 2020)
249:($ 1.01B revenue in 2017)
243:($ 2.44B revenue in 2017)
237:($ 2.79B revenue in 2020)
231:($ 2.92B revenue in 2020)
225:($ 4.41B revenue in 2020)
219:($ 4.68B revenue in 2020)
977:Thermo Fisher Scientific
788:Labcorp Drug Development
2015:Pharmaceutical industry
1728:Pharmaceutical industry
1628:Alexion Pharmaceuticals
1260:Reliant Pharmaceuticals
91:entry into drug markets
89:. They aim to simplify
2127:Pharmaceuticals policy
1817:Anatomy of an Epidemic
1653:Amylin Pharmaceuticals
1512:European Pharmacopoeia
1235:The Distillers Company
1104:Dechra Pharmaceuticals
548:www.clinicalleader.com
402:Fanelli, Alex (2017).
181:Market size and growth
142:good clinical practice
1658:ARIAD Pharmaceuticals
1497:British Pharmacopoeia
1492:British Approved Name
1124:Hikma Pharmaceuticals
972:Syngene International
276:Research organization
189:Further information:
175:risk-based monitoring
1307:Department of Health
1205:Allen & Hanburys
1169:Silence Therapeutics
502:on December 18, 2010
106:sponsor of the trial
64:clinical development
1695:Professional bodies
1613:Acorda Therapeutics
1608:Abbott Laboratories
1358:professional bodies
1067:AAH Pharmaceuticals
828:WNS Global Services
808:PRA Health Sciences
748:Craven Laboratories
191:Functional sourcing
80:real world evidence
1910:Related categories
1618:Adolor Corporation
1409:Books and journals
924:UnitedHealth Group
904:Oracle Corporation
894:Medidata Solutions
833:Wolfe Laboratories
463:2013-09-26 at the
430:2009-01-01 at the
336:2013-07-03 at the
169:Guidance from the
2117:Clinical research
2094:
2093:
1981:
1980:
1872:Related templates
1679:Regulatory bodies
1663:Avax Technologies
1555:
1554:
1295:regulatory bodies
1288:
1287:
1090:
985:
984:
721:Clinical Research
426:, Biotech Media.
424:"Bio-Definitions"
150:quality assurance
76:outcomes research
72:pharmacovigilance
16:(Redirected from
2134:
2122:Drug development
2008:
2001:
1994:
1985:
1971:
1970:
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758:ePharmaSolutions
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331:"The CRO Market"
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319:"The CRO Market"
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60:biological assay
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1139:MacFarlan Smith
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381:Clinical Leader
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329:
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154:quality control
135:clinical trials
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68:clinical trials
28:
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526:. Retrieved
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497:the original
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144:guidelines:
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70:management,
39:
35:
29:
2067:Switzerland
1945:Switzerland
1144:Mundipharma
1082:AstraZeneca
889:LTIMindtree
838:Wuxi Apptec
506:February 5,
409:13 December
247:Wuxi Apptec
2101:Categories
2027:Bangladesh
2017:by country
1825:Bad Pharma
1801:Big Pharma
1733:Bangladesh
1424:Bad Pharma
1255:Phytopharm
1164:Proximagen
813:Retrogenix
528:2020-05-20
355:Activa CRO
305:2022-01-22
300:Forbes.com
282:References
56:outsourced
1920:Australia
1601:Companies
1502:DrugScope
1417:Bandolier
1159:Pfizer UK
1087:MedImmune
1052:Companies
914:Cognizant
859:Clarivate
854:Accenture
803:PPD, Inc.
217:PPD, Inc.
101:, etc.).
2057:Pakistan
1974:Category
1879:Medicine
1748:Pakistan
1638:Allergan
1633:Alkermes
1546:category
1225:Celltech
1210:Amersham
1184:Vernalis
1129:Indivior
1099:Cyclacel
899:Merative
874:Indegene
773:Icosagen
768:ICON PLC
753:Dokumeds
461:Archived
428:Archived
334:Archived
260:See also
235:ICON PLC
2052:Nigeria
1930:Finland
1669:more...
1275:Unipath
1198:Defunct
1179:Vectura
1060:Current
967:Labcorp
957:Cencora
884:Infosys
879:Informa
869:HCLTech
798:Parexel
793:Medpace
783:KCR CRO
387:30 July
253:Medpace
241:Parexel
205:Labcorp
30:In the
2062:Russia
1925:Canada
1828:(2012)
1820:(2010)
1812:(2008)
1804:(2006)
1796:(2004)
1788:(2002)
1780:(1994)
1470:(2008)
1427:(2012)
1280:Zeneca
1265:Renovo
1240:Fisons
1174:TBS GB
962:Cytiva
743:CLARIO
674:Nasdaq
171:US FDA
78:, and
50:, and
2047:Japan
2042:India
2032:China
1940:Japan
1935:India
1836:Lists
1769:Books
1743:India
1738:China
1648:Amgen
1623:Alcon
1485:Other
1270:Shire
1134:IXICO
1114:Genus
1077:Astex
941:Wipro
929:Optum
864:Cytel
778:IQVIA
728:Calyx
500:(PDF)
493:(PDF)
211:IQVIA
2037:Iran
1643:Alza
508:2013
411:2017
389:2022
152:and
129:The
34:, a
1250:ICI
1119:GSK
1094:BTG
115:EMA
111:FDA
99:EMA
95:NIH
40:CRO
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