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Contract Research Organization

A contract research organization (CRO) provides support services to pharmaceutical, biotechnology, and medical device companies on an outsourced basis. CROs conduct research like clinical trials and product development to help companies develop new drugs and reduce costs. The top CROs generate billions in annual revenue, with Labcorp and IQVIA being the largest. Regulatory bodies provide guidelines making sponsors responsible for CRO work quality.

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34 views6 pages

Contract Research Organization

A contract research organization (CRO) provides support services to pharmaceutical, biotechnology, and medical device companies on an outsourced basis. CROs conduct research like clinical trials and product development to help companies develop new drugs and reduce costs. The top CROs generate billions in annual revenue, with Labcorp and IQVIA being the largest. Regulatory bodies provide guidelines making sponsors responsible for CRO work quality.

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shiksha.rawat96
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Contract research

organization

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.[1]

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.).[2]

Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical
devices.[3][4] However, the sponsor of the trial retains responsibility for the quality of the CRO's
work.[5] 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,[6] without the
drug sponsor having to maintain a staff for these services.[7]

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.[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:[8]: 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:[8]: 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.[5] 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".[5]

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.[9] The
industry is fragmented, with the top 10 companies controlling 56% of the market in 2008[10] and
55% in 2009.[11] 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.[12]

Top CROs by annual revenue


As of 2016, there was a 15.5% increase in R&D spending from 2015 to 2020.[13] The list of
contract research organizations includes the following notable companies worldwide:
1. Labcorp ($14.00B revenue in
2020)[14]
2. IQVIA ($11.35B revenue in 2020)[15]
3. PPD, Inc. ($4.68B revenue in 2020)[16]
4. Syneos Health ($4.41B revenue in
2020)[17]
5. Charles River Laboratories ($2.92B
revenue in 2020)[18]
6. ICON PLC ($2.79B revenue in
2020)[19]
7. Parexel ($2.44B revenue in 2017)
8. Wuxi Apptec ($1.01B revenue in
2017)
9. Medpace ($0.92B revenue in 2020)[20]
5. Sather, Sandra; Lawyer, Jennifer (30 June
2022). "CRO Oversight Essentials" (https://
www.clinicalleader.com/doc/cro-oversight-
essentials-0002) . Clinical Leader (Guest
column). Pennsylvania, United States:
VertMarkets. Retrieved 30 July 2022.

6. Fanelli, Alex (2017). "Contract Research


Organizations (CRO)" (http://www.cell-trans
fection.com/transfection-cro-services/) .
Retrieved 13 December 2017.

7. "Bio-Definitions" (http://www.biotechmedia.
com/definitions-c.html) , Biotech Media.
Archived (https://web.archive.org/web/200
90101162837/http://www.biotechmedia.co
m/definitions-c.html) 2009-01-01 at the
Wayback Machine

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