Contract research organization
{{Short description|Company that is paid to provide research}}
In the life sciences, 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, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence.{{cite web|author=Nick Lucas |url=https://www.forbes.com/sites/forbestechcouncil/2021/04/09/contract-research-organizations-key-partners-in-the-drug-development-journey/?sh=12ac5f057a58 |title=Contract Research Organizations: Key Partners In The Drug Development Journey |work=Forbes.com |date=2021-04-09 |accessdate=2022-01-22}}
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. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).[https://web.archive.org/web/20100311082536/http://www.acrohealth.org/cro-market.php "The CRO Market"], Association of Clinical Research Organizations.
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[http://www.acrohealth.org/cro-market1.html "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.{{cite web|url=https://www.activa-cro.com/|title=Contract Research Organization|website=Activa CRO}} However, the sponsor of the trial retains responsibility for the quality of the CRO's work.{{Cite magazine |last1=Sather |first1=Sandra |last2=Lawyer |first2=Jennifer |date=30 June 2022 |title=CRO Oversight Essentials |url=https://www.clinicalleader.com/doc/cro-oversight-essentials-0002 |magazine=Clinical Leader |type=Guest column |location=Pennsylvania, United States |publisher=VertMarkets |access-date=30 July 2022}} 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,{{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}} without the drug sponsor having to maintain a staff for these services.[http://www.biotechmedia.com/definitions-c.html "Bio-Definitions"], Biotech Media. {{Webarchive|url=https://web.archive.org/web/20090101162837/http://www.biotechmedia.com/definitions-c.html |date=2009-01-01 }}
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 and success in one area cannot reliably predict success in unrelated areas that might be new to the organization.
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:[http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf E6(R2) Good Clinical Practice] International Council on Harmonisation good clinical practice, 66 ppp, amended Nov 2016, accessed 30 Jan 2018{{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:{{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.
Guidance from the US FDA published in 2013 also speaks to the responsibility of the sponsor to oversee work of the CRO, including the circumstance where risk-based monitoring 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".
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.[http://www.outsourcing-pharma.com/Clinical-Development/CRO-Industry-Could-See-More-Consolidation-Experts-Say "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 The industry is fragmented, with the top 10 companies controlling 56% of the market in 2008[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 and 55% in 2009.{{cite web|url=http://www.globalbusinessinsights.com/content/rbcr0015m.pdf |access-date=February 5, 2013 |url-status=dead |archive-url=https://web.archive.org/web/20101218005619/http://globalbusinessinsights.com/content/rbcr0015m.pdf |archive-date=December 18, 2010 |title=The CRO Market Outlook!publisher =globalbusinessinsights.com}} In 2018 global CRO 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.{{cite web
|url=https://www.fortunebusinessinsights.com/industry-reports/contract-research-organization-cro-services-market-100864
|title=Contract Research Organizations (CRO) services market |publisher=fortunebusinessinsights.com |date=2019-07-02 |access-date=2020-05-20 }}
{{Further|Functional sourcing}}
Top CROs by annual revenue
{{As of| 2016}}, there was a 15.5% increase in R&D spending from 2015 to 2020.{{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 }} The list of contract research organizations includes the following notable companies worldwide:
- Labcorp ($14.00B revenue in 2020){{cite web| url=https://www.businesswire.com/news/home/20210211005467/en/Labcorp-Announces-2020-Fourth-Quarter-and-Full-Year-Results-and-Provides-2021-Guidance|title=Labcorp Announces 2020 Fourth Quarter and Full Year Results and Provides 2021 Guidance|date=2021-02-11|work=Businesswire}}
- IQVIA ($11.35B revenue in 2020){{cite web|url=https://www.businesswire.com/news/home/20210210005238/en/IQVIA-Reports-Fourth-Quarter-and-Full-Year-2020-Results-Raises-Full-Year-2021-Guidance |title=IQVIA Reports Fourth-Quarter and Full-Year 2020 Results, Raises Full-Year 2021 Guidance| date=2021-02-10| work=Businesswire}}
- PPD, Inc. ($4.68B revenue in 2020){{cite web|url=https://www.businesswire.com/news/home/20210223006094/en/PPD-Reports-Fourth-Quarter-and-Full-Year-2020-Results |title=PPD Reports Fourth Quarter and Full Year 2020 Results |date=2021-02-23| work=Businesswire}}
- Syneos Health ($4.41B revenue in 2020){{cite press release| url=https://www.globenewswire.com/en/news-release/2021/02/18/2177824/33420/en/Syneos-Health-Reports-Fourth-Quarter-and-Full-Year-2020-Results.html| title=Syneos Health Reports Fourth Quarter and Full Year 2020 Results| date=2021-02-18|work=Globenewswire}}
- Charles River Laboratories ($2.92B revenue in 2020){{cite web |date=2021-02-17 |title=Charles River Laboratories Announces Fourth-Quarter and Full-Year 2020 Results and Provides 2021 Guidance |url=https://www.businesswire.com/news/home/20210217005517/en/Charles-River-Laboratories-Announces-Fourth-Quarter-and-Full-Year-2020-Results-and-Provides-2021-Guidance |work=Businesswire}}
- ICON PLC ($2.79B revenue in 2020){{cite web|url=https://finance.yahoo.com/news/icon-reports-fourth-quarter-full-110100444.html| title=ICON Reports Fourth Quarter and Full Year 2020 Results| work=Yahoo Finance| date=2021-02-24}}
- Parexel ($2.44B revenue in 2017)
- Wuxi Apptec ($1.01B revenue in 2017)
- Medpace ($0.92B revenue in 2020){{cite web|url=https://www.nasdaq.com/press-release/medpace-holdings-inc.-reports-fourth-quarter-and-full-year-2020-results-2021-02-15|title=Medpace Holdings, Inc. Reports Fourth Quarter and Full Year 2020 Results|date=2021-02-15|work=Nasdaq}}
See also
References
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{{Contract research organization}}
{{Pharmaceutical industry in the United Kingdom}}
{{Pharmaceutical industry in the United States}}
{{Pharmaceutical industry by country}}
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Contract research organizations