Outsourcing drug development

Sarapa, N., Early human microdosing to reduce attrition in clinical drug development, Am. Pharm. Outsourcing, 4, 42-46, 2003. 

Norbert C (2010) Outsourcing in drug development. Drug Development, 48-49... 

Although the scope of application continues to grow, the routine use of LC/MS technologies are now embraced by pharmaceutical researchers. Standard methods that incorporate highly specialized features are routinely developed for a variety of novel applications. Furthermore, many LC/MS applications that deal with quantitative bioanalysis (i.e., pharmacokinetics studies) are frequently outsourced to contract analytical laboratories. Thus, the routine use of LC/MS is a benchmarked commodity for drug development. 

Outsourcing strategies offer a highly flexible and adaptable strategy for clinical development support. This approach to drug development generally involves the use of contract research organizations (CROs) and contract analytical laboratories, which perform a variety of specialized clinical development-based functions. This practice has... 

Figure B8. The Drug Development Pathway and Outsourcing Opportunities...

The need for outsourcing parts or even all drug development activities to contract research organizations (CROs) and specialized external providers contributes to the complexity of developing new pharmaceuticals. 

Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs) Critical Success Factors... 

As pharmaceutical companies strive to increase productivity and decrease costs, they must improve their skills in dealing with CROs. This chapter examines the challenges of outsourcing clinical drug development activities and identifies critical success factors for working with CROs. 

CH54 OUTSOURCING CLINICAL DRUG DEVELOPMENT ACTIVITIES TO CONTRACT RESEARCH ORGANIZATIONS... 

With this strategy, the sponsor outsources nearly all of its clinical development activities to CROs. Some pharmaceutical senior executives have expressed the desire to minimize in-house staff and outsource everything . Small companies may have minimal, if any, drug development staff and must rely extensively on CROs. 

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