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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)] The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States. ...
FDA logo The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. ...
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] This article needs to be cleaned up to conform to a higher standard of quality. ...
Data management comprises all the disciplines related to managing data as a valuable resource. ...
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following: Is the drug...
Outsourcing in Clinical Research
Over the last few years, the pharmaceutical industry has seen large companies use ‘downsizing’ strategies more and concentrating 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. Outsourcing became part of the business lexicon during the 1980s and often refers to the delegation of non-core operations from internal production to an external entity specializing in the management of that operation. ...
Manufacturing is the application of tools and a processing medium to the transformation of raw materials into finished goods for sale. ...
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. Look up Market in Wiktionary, the free dictionary. ...
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 Global industry analysers estimated that pharmaceutical and biotechnology companies spent approximately $57 billion on R & D in 2005, out of which an estimated $14 billion was used for the outsourcing services offered by the CRO industry.This figure is expected to increase further with the broadening of the spectrum of services outsourced to cover the entire value chain. As the outsourced services to India move up the value chain to cover phase 1/2 trials, the total contracts value may go up to $20 billion by 2010.
See also It has been suggested that Gateway Medical Research be merged into this article or section. ...
It has been suggested that this article or section be merged with Cetero Research. ...
Ba Research International, previously known as Bioassay Laboratory, Inc. ...
Anaclim is a Contract Research Organization that recruits members of ethnic minorities into clinical research trials. ...
A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). ...
The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ...
The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry. ...
Secure Access For Everyone (SAFE), is a set of enforced standards that create a trusted community for legally enforceable Business to Business and Business to Government digitally signed transactions within the global biopharmaceutical industry. ...
According to most agreements between sponsor and investigator, Sponsor may control publication of results by requesting publication delays, deleting portions of a manuscript, or placing limits on the types of issues that can be discussed. ...
References Clinical Research Outsourcing Overview: Current Scenario & Future Outlook by Dr. Jayashree, IBPA publications 2005 Contract Research Organization exclusion criteria Target Health Inc., [e*CRO], www.targethealth.com, BLOG.targethealth.com
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