Contract research organization
From Biocrawler, the free encyclopedia.
Contract Research Organization is an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. CRO-s are independent companies carrying out specialized functions of Pharmaceutical Research and Development such as Phase I, Phase II, Phase III or Phase IV Clinical trial
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Outsourcing in Clinical Research
Over the last few years, the pharmaceutical industry has seen large companies use ‘downsizing’ strategies more and concentrates 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 an operation is a means of converting the fixed costs of maintaining the necessary personnel, infrastructure and expertise into the variable costs of paying a sub-contractor to perform that process when it is required. Outsourcing also gives companies the flexibility to acquire skills and technologies in a cost and time efficient way, thus avoiding having to get heavy financial backing to develop them in house. This strategy 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 direct to consumers.
There are three major reasons why such companies might take the decision to outsource some of their services : lack of capacity, skill deficiency and cost control. However, external cost pressures have also 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.
Typical outsourcing issues that sponsors consider include:
• When to outsource
• Vendor selection
• Retaining in-house expertise
• Cost-effectiveness
• Patient recruitment
• Regulatory and ethical issues
While cost is also a determinant for selecting a service provider, it typically ranks at or near the bottom of survey responses for outsourcing selection criteria. Key selection criteria usually include such elements as expertise in a specific therapeutic area, ability to deliver study participants, speed and a strong reputation.7
Answering “yes” to all of these questions would mean the work stays in house, while a “no” answer to any of the questions would advise outsourcing.
• Do we have in-house resources? • Are the resources available? • Would these resources be optimally employed on this project? • Is it cost-effective to do the project in-house? • Can we do it fast enough?
Reasons for outsourcing to Contract Research Organizations
Outsourcing offers a number of advantages to the companies. These include:
- Reduces the time (8 to 15 years) required to develop and bring a new drug to market
- 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
- Less knowledge of regulatory affairs in a particular country of interest
- Increased complexity of clinical trials
- Increased amount of data required from clinical trials
- Multinational and multi-center nature of current clinical trials
- Large requirement of patient populations
- Regionalized diseases
CRO market size and growth
Data monitor estimated that pharmaceutical and biotechnology companies spent approximately $33 billion on R & D in 1997, out of which an estimated $3.8 billion was used for the outsourcing services offered by the CRO industry. Data monitor’s figures for 1998 show that the CRO industry grew by approximately 11 percent, thus expanding the market size to $4.2 billion. So, the CRO market is expanding at a steady pace, a trend that is likely to continue in the near-term future. Therefore, pharmaceutical companies will need to re-evaluate their perceptions of, and relationships with, CROs – particularly if the strategic direction of the CRO market is about to change.
References
Clinical Research Outsourcing Overview: Current Scenario & Future Outlook (http://www.ibpassociation.org/IBPA_articles/Outsoursing.htm) by Dr. Jayashree, IBPA publications 2005 (http://www.ibpassociation.org/)
External links
- ICH Website (http://www.ich.org)
- FDA Website (http://www.fda.gov/)
- Clinical Research Training (http://www.kriger.com/training/index.htm)
- Careers in Clinical Research (http://www.biorole.com/)
- Clinical Research Services (http://www.clinqua.com/)
- Clinical Research Companies Listings (http://www.ibpassociation.com)
- International Clinical Research Services and Corporate Trainings (http://www.kriger.com/)
- Clinical Research Abbreviations and Acronyms (http://www.krctraining.com/ACRONYMS/index.htm)
- Clinical Research Glossary / Definitions (http://www.krctraining.com/CRA%20Definitions/index.htm)
- List of Food and Drugs Regulatory Agencies (http://www.kriger.com/international_modules/index.htm)
- Clinical Research: Frequently asked questions (http://www.krctraining.com/faq/faq.htm)
