Talk:Contract research organization

Number of CROs

The article references on 1,100 CROs, but I know there are many times that number. My company deals with the preclinical CRO market and have over 6,000 cataloged in our system (6582 as of writing to be exact). Take a look through our various pages upon pages of them: www[dot]assaydepot[dot]com/providers (note: link obfusticated to not send any spiders or other traffic there). Gremlyn1 (talk) 21:39, 30 July 2012 (UTC)

Get Rid of the Jargon

The first sentence under Regulatory Aspects starts, "Specifically pertaining to CROs providing clinical-trials services, the ICH-GCP (E6 1.20)..." Anyone who doesn't know what a CRO is surely will not know what "the CIH-GCP (E6 1.20) is. Whoever wrote that, please describe what it is before you introduce it. 99.33.85.12 (talk) 00:16, 30 July 2012 (UTC)

There are non-medical CROs, too; they just aren't as common. I don't know enough about the market to add this formally to the article.

Clinical Research Organization or Contract Research Organization

Is there a difference between these two definitions of CRO? — Preceding unsigned comment added by 82.23.61.41 (talk) 16:25, 7 March 2012 (UTC)

There are clinical and pre-clinical CROs. I think it would be useful to distinguish between the two whenever possible. Gremlyn1 (talk) 21:32, 30 July 2012 (UTC)

Clinical Research Organizations are Contract Research Organizations, but the reverse is not true. They only need distinguishing when necessary. --Cptbigglesworth266 (talk) 10:36, 8 April 2015 (UTC)

Merger from Contract Research Organization

This is the text from Contract Research Organization, which can be merged with this article.Marasmusine 11:31, 29 August 2006 (UTC)

A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration." [21 CFR 312.3(b)]

Services offered by CROs include: product development and formulation, clinical trial management (preclinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and many other complementary services. CROs can offer their clients the experience of moving a new drug from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services, which often have limited duration. [1]

I went ahead and put this text in to replace the old introduction paragraph anyway. Marasmusine 11:53, 29 August 2006 (UTC)

eCRO vs. CRO

It seems to me absurd to distinguish between these as I believe most CROs now utilized much digital infrastructure in their operations. Is there any evidence that this is anything more than marketing? --Xris0 04:37, 6 September 2007 (UTC)

If there aren't any good sources added to defend this distinction I'm going to delete this section because it doesn't make sense to me. --Xris0 (talk) 07:03, 7 January 2008 (UTC)

CRO list

The CROlike it is being modified by CROs to jockey their positions/appearance... probably should be watched to make sure it reflects an unbiased presentation. I removed eCRO tags per the above section. I combined a separate "Global CRO" list because I noticed that some of the CROs in the other sections were global and this distinction should probably only be made if all the organizations are put in the proper place, rather than one company putting itself in the separate section and leaving the others out (ie. what someone appeared to have done, ahem). I also changed link titles that were all caps and removed extraneous information (ie. stock ticker information). Trying to keep everything neutral...--Xris0 18:18, 16 October 2007 (UTC)--Xris0 18:18, 16 October 2007 (UTC)

Some CROs are listing their locations... might want to either not list locations or try to list for all to be balanced. On one hand might be useful to break down in countries, but that might be complicated due to, for example, USA-based CROs having operations in other countries.--Xris0 (talk) 03:36, 29 November 2007 (UTC)

I had added a CRO link on wikipedia as i could see other links on this artile but that link was removed. i represent a cro in india and want to know that why it was deleted. The cro is Fermish Clinical Technologies Pvt Ltd —Preceding unsigned comment added by 122.162.157.143 (talk) 03:25, 10 December 2007 (UTC)

You are not following NPOV edit guidelines. You are adding 3 links for yourself on the top, and putting in distinguishing descriptive text. This isn't rocket science; just add a single simple link like all the others or stop wasting editors' time by editing this page. --Xris0 (talk) 07:00, 7 January 2008 (UTC)

I am not the person above, but I didn't think I was wasting editors time when I added a link to Siro Clinpharm which is the largest CRO in India, under Contract Research Organizations a week or so back. I didn't think you'll should have deleted just because it does not have its own Wiki page and the link was to the Siro Clinpharm Website. --123.236.29.73 (talk) 16:06, 4 August 2008 (UTC)

How about changing it from "Notable CROs" to "Top CROs by Revenue" or provide some other clear criteria for inclusion? Otherwise we're going to end up with a massive list of CROs who are the largest in their own country but otherwise not particularly notable. TomorrowsDream (talk) 11:55, 28 April 2009 (UTC)

Clean-up of lists

Well Wikipedia is not supposed to be a list of links for one and secondly that list is far from comprehensive. There are several, including the one that I work for, that are larger, have more international coverage in the media and are more notable than several in that list. If the CRO is important it should have its own article.Peter Rehse (talk) 13:31, 2 May 2008 (UTC)

I notice the one I work for is in the list but still the point still stands as marked by the clean-up tag. If the company is important it should have its own article.Peter Rehse (talk) 13:35, 2 May 2008 (UTC)

Article Update and Addition of References

Made a proposed significant update to the article, as citations and references were completely absent, and the introductory section was relatively incorrect. Edits are encouraged, references to publicly-available external articles should be accurate. Azupnick (talk) 21:36, 7 January 2009 (UTC)

It's not proposed if you made the edits in the mainspace. :) You might want to look at WP:MOS to see Wikipedia's writing style and WP:RS for sourcing info. There are editors who can help with technical and trade sourcing as well. Flowanda | Talk 23:00, 7 January 2009 (UTC)

Speedy Deletion

This is a valid encyclopedic article within the Pharmaceutical industry category unless the information is covered in a more appropriate article (and if so, where?). It is by no means spam. Company-specific information that constituted advertising has already been removed. The article needs improved structure to bring it up to encyclopedia standards. The article should be expanded to address: (a) the criticality to pharmaceutical development as pharma companies can no longer afford to maintain their own large organisations, (2) the different types of CROs (clinical, central labs etc), (3) the different models of CRO outsourcing (full service vs functional). TomorrowsDream (talk) 08:24, 27 July 2009 (UTC)

Big press release?

Damien, do you know what you are talking about? I don't see how a report from IMS Health about the future growth of the CRO market constitutes a "big press release" or advertising. Instead of just deleting half the article, perhaps you could spend some time improving it or even providing some justification for excessive editing? TomorrowsDream (talk) 14:33, 22 July 2011 (UTC)

Merger Proposal

I propose that List of contract research organizations be merged with this article. the list article gives little additional information, that information should probably be included here, and the list is also a frequent target for drive-by spam/ads. -- UseTheCommandLine (talk) 00:49, 26 January 2013 (UTC)

I support merging the two pages. I feel the List of contract research organizations page is fairly outdated and specific only to clinical research groups, completely ignoring the preclinical side of things. I don't feel like The Big 7 and Other Organizations sections are particularly meaningful as The Big 7 refers only to clinical companies, and the Other Organizations section and will likely attract attempts for companies to list themselves there. Gremlyn1 (talk) 22:35, 5 February 2013 (UTC)

I'm not sure I understand your concern. To the extent that the term "CRO" appears in the medical literature, it refers to clinical research organizations. as i understand it, organizations that do preclinical research are more likely to originate drug entitues and license them out or sell them to larger drug companies. Thus, not really "contract" but more "startup". I would be interested in any information you might have that says otherwise. I am probably going to put the big 7 back into the article, at minimum. Any article that talks about CROs and doesnt at least mention quintiles and maybe parexel is, in my view, unencyclopedic, since they are the two biggest. -- UseTheCommandLine (talk) 23:15, 5 February 2013 (UTC)

If you are looking in specifically medical literature then I expect that you're biasing your sample of references. Though the preclinical CRO market isn't quite to the size of the clinical market in terms $bn/year, it outnumbers the clincal market in terms of companies (a lot of the money going into the clinical market is due to regulatory requirements - it's a lot more expensive to test a drug on humans than on mice, and that largely accounts for the difference in market size between preclinical and clinical). I take it you don't work in drug discovery and are basing your information solely off of research? Preclinical CROs seldom originate potential drugs, and you're right that wouldn't be very 'CRO' of them if they did. The small, often partially or completely virtual, pharma companies that do originate new drug candidates regularly use preclinical CROs to perform their research and sell those candidates off to larger pharma companies once they get through IND or Phase 1 clinical trials.

To start with, check out this Preclinical Outsourcing Report for an idea of the market, at least from a 2009 perspective. Here is a good, albeit slightly old, short piece that highlights differences in the clinical vs preclinical CROs and talks a little more in depth about the preclinical side of things: Trends for Preclinical CROs. This one is a research report about the CRO industry, and while the report itself requires payment, the intro gives some decent information. You can also take a look at this for preclinical CROs, or this much larger one (full disclosure: I work for the company providing the last link and am providing the link solely to give you an idea of the size of the market).

The point I am trying to make is that preclinical CROs are a huge part of the drug discovery industry and should not be ignored or simply lumped in with the clincal CROs since they are so different. There are vertically integrated companies that work in both the preclinical and clinical space, such as Covance, and I think a good encyclopedic article should mention such crossover as well.

On the topic of company lists: my biggest problem with putting up lists (especially ordered lists) of companies top in an industry is that there is usually a fair amount of jostling up and down from year to year, and even within the same year depending on the report you're looking. Lists can become outdated so quickly, and are seldom updated by page maintainers with any sort of regularity. I'm not against mentioning ANY companies, but maybe the format and/or context can be revised from a simple 'top 7' list to something a little less ranked, and hopefully split up between clinical and preclinical. Gremlyn1 (talk) 00:09, 7 February 2013 (UTC)

Ah, fair enough. I appreciate the thorough treatment you've given the topic here, as well as your disclosure. I admit to some trepidation about using the sort of industry-insider publications you list, but I suppose we can see how it goes. When I have some time I will search for some precedents at WP:RSN, as I expect that that will be one of the biggest challenges with developing this article further. I'm clearly being a little knee-jerk-y about the whole thing because so much of the maintenance on these articles since i've started watching them has been spam policing (thus the recent rash of AfD submissions, which I intend to continue).

The terminology starts to become a problem too, I think -- the C variously refers to contract or clinical, depending on who you're asking, but it's always "CRO" somehow.

Your point is also well-taken about the lists, but I definitely thing Quintiles and Parexel should be mentioned, being the biggest of them and most associated with the "CRO" term in the medical literature.

And you're right, I don't work in drug discovery, though I have done a bit of wet lab work in the past.-- UseTheCommandLine (talk) 00:55, 7 February 2013 (UTC)

The terminology is definitely a tough one because of the variation. Would it be at all un-Wiki-like to list potential variations in the opening paragraph, but then state that 'CRO' in following article would refer to 'contract research organization'. It would be much easier to append 'preclinical' or 'clinical' in front of 'CRO' when the distinction is needed. Gremlyn1 (talk) 22:46, 7 February 2013 (UTC)

clinical/preclinical

So I did a pubmed search, "preclinical CRO" and the overwhelming majority of hits i got back were from a journal Critical Reviews in Oncology. this, i think, supports the use of the term "CRO" as mainly a clinical phenomenon. I've reverted the recent edits, but as noted above I would be interested in hearing other perspectives; what WP:RS-compliant literature talks about preclinical CROs in addition to clinical CROs? -- UseTheCommandLine (talk) 06:40, 6 February 2013 (UTC)

pending changes protection

So I made a request for semi-protection (because i wasnt aware of the pending changes option) and the article has been placed on pending changes protection, because of the incessant targeting of the article by spammers, typically coming from ip addresses or single-use unconfirmed accounts. I'm hoping that this will reduce the vandalism-policing burden, as these changes will not go live until accepted by a confirmed user. Admittedly, this was a much worse problem when there was a separate "List of contract research organizations" page, but it's still a pain.

autoconfirmed users' changes will go live immediately. this is just to provide oversight of edits from ip editors and non-confirmed users. -- UseTheCommandLine (talk) 14:05, 11 February 2013 (UTC)

Good idea, thanks! Gremlyn1 (talk) 02:47, 13 February 2013 (UTC)

Narrower title ?

Please consider narrowing the title to pharmaceutical subject, e.g. Contract research organisation (Pharmacology). Contract research is in fact performed in many other subject areas. LHOON (talk) 10:13, 10 August 2015 (UTC)

I strongly support this suggestion. At least in the UK and at least in the early years of CRO's, the term CRO carried no implication that it related exclusively to pharmaceutical work. See for example: The Science and Engineering Policy Studies Unit(SEPSU) (1991),”The Contract Research Business in the UK”, Policy Study No 6, The Royal Society & The Fellowship of Engineering. Also: New Scientist Supplement:Contract Research Review, 2 May 1974. DavidGSDavies (talk) 15:21, 15 April 2017 (UTC)

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A Magnificent Text Book of Pharmacovigillance

A book titled A Magnificient Text Book Of Pharmacovigillance (sic) by Zakir Hussaain, published on 28 Dec 2019 by Orangebooks contains several paragraphs of text lifted verbatim from the lede of this article. See p.41 of this book where CRO is defined: Google book link. This book does not cite Wikipedia (or any other publication) as a source. Its publication date of 28 December 2019 is more recent than the article, suggesting it was copied from the article rather than the other way around. Additional proof of this Wikipedia plagiarism is the fact that a "[4]" citation reference from the Wikipedia article is retained in the book text, when this book does not even use that format for its bibliographic references, or even provide any other such references elsewhere in its text.

Given this, A Magnificient Text Book Of Pharmacovigillance should not be used as a citation for this article. Doing so would create a circular reference. I discovered this situation by Googling some text in the lede that was flagged 'Citation needed', attempting to hunt down a reasonable source for that information. A Magnificent Text Book... is not a good source!

SteveChervitzTrutane (talk) 01:08, 4 March 2020 (UTC)

Section “Top CROs by annual revenue” Outdated

Section “Top CROs by annual revenue” is outdated. Rank list should be updated to reflect revenue from 2022. 2600:1012:B17F:40A7:8160:2881:C5C2:C928 (talk) 09:33, 3 May 2023 (UTC)

Expand Scope of Wiki

There are CROs such as MRIGlobal and Battelle which manage DOE funded sites for sustainable energy research. 2600:100E:B061:20DB:51F0:673D:7770:DBF1 (talk) 15:41, 8 February 2024 (UTC)