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词条 Contract research organization
释义

  1. Definition, regulatory aspects

  2. Market size and growth

  3. List of companies by annual revenue

  4. See also

  5. References

{{update|reason=figures cited are from 2007-2015|date=June 2018}}

A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant.{{citation needed|date=June 2018}} CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).[1]

Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2][3] 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 FDA/EMA marketing approval,[4] without the drug sponsor having to maintain a staff for these services.[5]

Definition, regulatory aspects

The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as:[6]{{rp|10}} "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."

It further details the sponsor's responsibilities in its good clinical practice guidelines:[6]{{rp|22-23}}

  • (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 quality assurance and quality control.
  • (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).
  • (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
  • (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.

Market size and growth

{{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.[7] The industry is fragmented, with the top 10 companies controlling 56% of the market in 2008[8] and 55% in 2009.[9][10] One estimate from 2007 had the size of the market set to reach $24 billion in 2010[11] and another estimate from 2009 set to grow at a rate of 8.5% through 2015.[12]

List of companies by annual revenue

{{As of| 2016}}, there was a 15.5% increase in R&D spending from 2015 to 2020.[13] {{As of| 2017}}, IgeaHub considered the top CROs by revenue to be:[14]
  1. Laboratory Corporation of America Holdings (Covance) ($10.44B revenues in 2017)
  2. IQVIA ($9.74B revenues in 2017)
  3. Syneos Health ($2.67B revenues in 2017)
  4. PAREXEL International Corporation ($2.44B revenues in 2017)
  5. PRA Health Sciences ($2.26B revenues in 2017)
  6. Pharmaceutical Product Development (PPD) ($1.90B revenues in 2017)
  7. Charles River Laboratories International Inc (CRL) ($1.86B revenues in 2017)
  8. ICON Public Limited Corporation ($1.76B revenues in 2017)
  9. Wuxi Apptec ($1.01B revenues in 2017)
  10. Medpace Holdings, Inc ($0.44B revenues in 2017)

See also

  • List of pharmaceutical companies

References

1. ^[https://web.archive.org/web/20100311082536/http://www.acrohealth.org/cro-market.php "The CRO Market"], Association of Clinical Research Organizations.
2. ^"The CRO Market" {{webarchive|url=https://web.archive.org/web/20130703015342/http://www.acrohealth.org/cro-market1.html |date=2013-07-03 }}, Association of Clinical Research Organizations.
3. ^{{Cite web|url=http://www.activa-cro.com/contract-research-organization.php|title=Contract Research Organization|last=|first=|date=|website=Activa CRO|publisher=|access-date=}}
4. ^{{cite web|title=Contract Research Organizations (CRO)|first1=Alex|last1=Fanelli|url=http://www.cell-transfection.com/transfection-cro-services/|date=2017|access-date=13 December 2017}}
5. ^"Bio-Definitions", Biotech Media. {{Webarchive|url=https://web.archive.org/web/20090101162837/http://www.biotechmedia.com/definitions-c.html |date=2009-01-01 }}
6. ^1 E6(R2) Good Clinical Practice International Council on Harmonisation good clinical practice, 66 ppp, amended Nov 2016, accessed 30 Jan 2018
7. ^"CRO Industry Could See More Consolidation, Experts Say" {{Webarchive|url=https://web.archive.org/web/20130926203837/http://www.outsourcing-pharma.com/Clinical-Development/CRO-Industry-Could-See-More-Consolidation-Experts-Say |date=2013-09-26 }} outsourcing-pharma.com, 2013-06-20 Retrieved 2013-09-24
8. ^[https://web.archive.org/web/20100205075135/http://www.bioportfolio.com/cgi-bin/acatalog/The-Top-10-Contract-Research-Organizations-Positioning_-performance-and-SWOT-analyses.html The Top 10 Contract Research Organizations -Positioning, performance and SWOT analyses] bioportfolio.com, 5 February 2010
9. ^{{cite web|url=http://www.globalbusinessinsights.com/content/rbcr0015m.pdf |accessdate=February 5, 2013 |deadurl=yes |archiveurl=https://web.archive.org/web/20101218005619/http://globalbusinessinsights.com/content/rbcr0015m.pdf |archivedate=December 18, 2010 |title=The CRO Market Outlook!publisher =globalbusinessinsights.com}}
10. ^{{cite web |url=http://www.outsourcing-pharma.com/Clinical-Development/Quintiles-in-3bn-investment-deal |title=Quintiles in $3bn investment deal |publisher=Outsourcing-pharma.com |date=2008-01-02 |accessdate=2010-08-03 }}
11. ^{{cite web |url=http://www.outsourcing-pharma.com/Clinical-Development/CRO-market-to-reach-24bn-by-2010 |title=CRO market to reach $24bn by 2010 |publisher=Outsourcing-pharma.com |date=2007-07-30 |accessdate=2010-08-03 }}
12. ^{{cite web |url=http://www.allbusiness.com/trade-development/economic-development/13007133-1.html |title=Reportlinker Adds The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends. | Trends & Events > Trends from |publisher=AllBusiness.com |date=2009-09-21 |accessdate=2010-08-03 |deadurl=yes |archiveurl=https://web.archive.org/web/20100831042451/http://www.allbusiness.com/trade-development/economic-development/13007133-1.html |archivedate=August 31, 2010 |df= }}
13. ^{{Cite web|author=Ed Miseta|url=http://www.clinicalleader.com/doc/clinical-outsourcing-market-to-see-continued-growth-through-0001|title=Clinical Outsourcing Market To See Continued Growth Through 2020|website=www.clinicalleader.com|date=11 February 2016 }}
14. ^{{Cite news|author = Luca Dezzani | url=https://www.statista.com/statistics/732804/top-clinical-research-organizations-by-revenue/|title=Top 10 Global CROs 2018|last=|first=|date=2018-03-15|work=IgeaHub Pharmaceutical Club|access-date=2018-06-25|via=}}
{{Pharmaceutical industry in the United Kingdom}}{{Pharmaceutical industry in the United States}}{{Pharmaceutical industry by country}}{{DEFAULTSORT:Contract Research Organization}}

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