Responsibilities of Sponsor, FDA regulatory requirements, ICH requirements

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Responsibilities of Sponsor , FDA Regulatory Requirements , ICH Requirements

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Responsibilities of Sponsor , FDA Regulatory Requirements , ICH Requirements

Outsourcing is a group of persons or representatives that specialize in certain areas of business operations , such as subcontractors , that are hired by big business companies . Because of outsourcing , production expenses have been lowered and productivity had increased which is the main reason why it is being utilized by most companies especially the big pharmaceutical companies

Outsourcing by pharmaceutical companies began in 1980s and increased or

br expanded in the 1990s along the areas of clinical trials , contract manufacturing and sales force solutions . Nearly 42 of pharmaceutical drugs development expenditures have committed to outsourcing by 2004 as compared to the 4 in the early 1990s . It is estimated that there currently over 1 ,200 in the clinical research . Study shows that while the low cost of production is the primary reason of companies for outsourcing , only 30 said that saving money is their main reason for outsourcing 90 said they are satisfied with the outsourcing to date and 83 said that the value of the benefits they get from outsourcing cannot be measured in dollars alone

In pharmaceutical industry , CROs or Contract Research Organization are the ones being assigned to do the job of outsourcing . Contract Research Organization is a group or system composed of people with different skills on specialized areas that offer various services from product research and development , clinical management , data management for New Drug applications to...