Ophthalmic Research Training
9050 Summerfield Rd
Temperance, MI 48182
9050 Summerfield Rd
Temperance, MI 48182
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Ophthalmic Research Training Services
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You have entered this page because you are seeking further information in the areas of Clinical Research pertaining to the
science of vision - Ophthalmic - Ophthalmologist - Ophthalmology.
Ophthalmic Research Training Services provides critical training to help you attract sponsors needing medical professionals like yourself to hold clinical trials on their products.
A contract research organization, also called a clinical research organization, (CRO) is a service
organization that provides support to the pharmaceutical and biotechnology industries in the form of
outsourced pharmaceutical clinical research services (for both drugs and medical devices). 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.
In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a contract research organization (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 contract research organization (CRO) industry emerged mostly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly-growing therapeutic areas increased. In order to realize profit margins and be competitive, pharmaceutical companies began outsourcing activities to other organizations (CROs). This frees money that pharmaceutical companies were using employee infrastructure which can then be devoted to clinical research and development. Contract research organization 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. Due to the success of outsourcing in these areas, pharmaceutical companies have began outsourcing more core processes such as Data Management, Database Development, and Medical Coding. The concept of outsourcing a particular function to a contract research organization (CRO) is often referred to as Functional Sourcing. 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, Contract research organizations will become more and more important strategic partners for pharmaceutical companies. A significant portion of R&D budgets are used for the outsourcing services offered by the contract research organization (CRO) industry, approximately $15 billion in 2007. 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 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). Outsourcing offers a number of advantages to drug companies such as:
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