contract research organisation

Contract research organization
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A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support to the pharmaceutical/biotech industry. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research & development process.[1] 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, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.[2]
Contents
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* 1 Outsourcing in clinical research
* 2 Reasons for outsourcing to CROs
* 3 CRO market size and growth
* 4 References

[edit] Outsourcing in clinical research

The CRO industry developed mostly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly-growing therapeutic areas increased. Particularly over the last few years, this forced the pharmaceutical industry to utilize ‘downsizing’ strategies more to concentrate resources on core skills. As industry margins come under increasing pressure, companies could begin outsourcing aspects of their development, manufacturing or marketing processes so as to concentrate on their core specialties.

Outsourcing has been particularly influential in the pharmaceutical industry as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry, computer integrated manufacturing and marketing medicines directly to consumers.

External cost pressures have acted as a major driver for the pharmaceutical outsourcing market. At bottom, the outsourcing market has developed in response to the downward and upward cost pressures exerted on pharmaceutical manufacturers’ profit margins. Given that such pressures are likely to increase in the future, CROs will become more and more important strategic partners for pharmaceutical companies. It is, therefore, in the latter’s interest to consider probable developments in the CRO market and its major players.
[edit] Reasons for outsourcing to CROs

Outsourcing offers a number of advantages to drug companies. These include:[3] [4]

* Sponsor can convert the fixed costs of maintaining the personnel, expertise and facilities like data management necessary for clinical trial management into variable costs
* Non-availability of services in-house
* Knowledge of regulatory affairs in a particular country of interest
* Increased complexity of clinical trials
* Necessity for medical and clinical knowledge in specific therapeutic areas or indications
* Increased amount of data required from clinical trials
* Multinational and multi-center nature of current clinical trials
* Large requirement of patient populations
* Regionalized diseases

To effectively evaluate the potential impact of outsourcing, it is important to understand the CRO selection process,[5] and the key factors in CRO selection.[6]
[edit] CRO market size and growth

Industry analysers IMS Health and BCC Research estimate that the global pharmaceutical market will grow at about a 5% rate in 2009 to over $820 billion[7] and be worth over $1 trillion by 2013[8]. Pharmaceutical and biotechnology companies in the US spent approximately $59 billion on R&D in 2007, which equates to roughly 18% of their sales and is a 5% increase from the previous year.[9]

A significant portion of R&D budgets are used for the outsourcing services offered by the CRO industry, approximately $15 billion in 2007.[10] This figure is expected to grow at 15% over the next seven years and should increase further with the broadening of the spectrum of services outsourced to cover the entire value chain. As outsourced services in developing countries such as China and India move up the value chain to cover phase 1/2 trials, the total contracts value may go up to $20 billion by 2010. Further, certain therapeutic areas within pharmaceutical development are slated for an even greater growth curve, namely the oncology class, expected to see continued growth of upwards of 21% over the next few years [11] due to the large target market, strong unmet medical need, and overwhelming number of drugs currently in development (667 for cancer vs. 252 for CNS disorders, 206 for cadiovascular disorders, and 186 for infections).[12] [13]
[edit] References

1. ^ "The CRO Market", Association of Clinical Research Organizations.
2. ^ "Bio-Definitions", Biotech Media.
3. ^ "Managing the Moving Parts", Taren Grom, PharmaVOICE View on Clinical Services, June 2007.
4. ^ "Is it Virtuous to be Virtual? The VC Viewpoint", Justin Chakma, Jeff L Calcagno, Ali Behbahani and Shawn Mojtahedian, Nature Biotechnology Volume 27, Number 10, October 2009.
5. ^ "Outsourcing the Biotech Trial", Frank Henke, Applied Clinical Trials, Volume 17, Number 6, June 2008.
6. ^ "Key Factors in CRO Selection", Harold E. Glass and Daniel P. Beaudry, Applied Clinical Trials, Volume 17, Number 4, April 2008.
7. ^ "IMS Global Pharmaceutical and Therapy Forecast", IMS Health, Pharmalive.com 2008.
8. ^ "Global Pharmaceutical Markets", BCC Research, 2008
9. ^ "Record R&D investment in US", Nick Taylor, Decision News Media SAS, March 27, 2008.
10. ^ "New Research offers CRO market snapshot", Kirsty Barnes, Outsourcing-Pharma, November 22, 2007.
11. ^ "Riding the Wave", Pharmaceutical Executive Europe, FOCUS Oncology, September 2007, pp. 3-5.
12. ^ "Top 10 Areas of Research", Michael D. Christel, R&D Directions, vol. 14, no. 9, October 2008, pg. 20.
13. ^ Celticor Clincal Research and Site Management Coimbatore www.celticor.com

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Categories: Contract research organizations | Biotechnology | Clinical research | Pharmaceutical industry | Pharmaceuticals policy