Understanding Contract Research Organization The contract research organization or CRO is an outsourced organization that provides support to pharmaceutical, biotechnology, medical device industries, and also serves government institutions, foundations, and universities in the form of research services, which are on a contract basis. From large, international full service organizations to small, specialty groups, these are the range types of CROs. Organizations and businesses contract with CROs to acquire their specific expertise without hiring a permanent staff, for the simple reason of reducing the time it takes to conduct a trial against doing the trial in-house, which translates to significant cost savings. By hiring CROs, the hiring organizations do not need the infrastructure, office space or manpower to run these trials themselves. From site selection and patient enrollment to final regulatory approval from the government regulatory agency, such as the Food and Drug Administration, some CROs manage almost all these aspects of a clinical trial and this depends on the terms of the contract. Even with the agreed term that the CRO will manage all clinical trials, the hiring organization remains responsible for the integrity of the data and ensures that all obtained data are factual and backed by good science and research. Types of comprehensive services provided by CROs are: project management, data base design and build, data entry and validation, clinical trial management, medicine and disease coding, quality and metric reporting, statistical analysis plans and reports, validation programming, safety and efficacy summaries, and final study report. Among the services provided by CROs, the Association of Clinical Research Organizations estimates that more than 50% of these services are into pharmaceutical industries, 27% for biotech and the remaining percentage for the medical device industries, foundations and government institutions. Among the CROs work for pharmaceutical industries, the top therapeutic areas are oncology, central nervous system, infectious disease, metabolic disorders, and cardiovascular disease.
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As the pharmaceutical industries and medical devices organizations face the increasing pressure on high costs of drugs, they are looking for ways to lower the drug prices without sacrificing profits, and they have realized their objective through the outsourcing of CROs. Outsourcing CROs to conduct clinical trial management is a way for these industries to significantly lower overhead costs, which in turn help them make up for the dollars lost for lowering the medication prices. Before the existence of CROs, pursuing the approval of a drug was prohibitively expensive and can only be approved when companies can guarantee that the drug will be sold to a large market, but with the CROs’ services, it has provided an outlet that is more affordable for companies to pursue new medications. The cost-effective services of CROs have helped more companies to develop smaller drugs for special case groups.Designs – My Most Valuable Tips