Research outsourcing

The extent to which the current trend toward mergers and acquisitions continues in life sciences, and also the extent to which larger pharmaceutical companies outsource research and development to smaller companies. It may become necessary for rapid integration of systems between companies that had previously had no relationship at all, and for the secure integration of particular systems between collaborating companies. 

In 1975, the first commercial entity was formed to provide multicenter, outpatient clinical trial contracting services in the United States. This was the beginning of the modern Contract Research Organization (CRO) industry. It is now composed of thousands of domesfic and infernafional firms involved in medical producf evaluations in humans. The total annual expense globally for clinical trials and related functions necessary for commercial, governmenf, and academic therapeutic product development is estimated at US 50 billion, of which about US 15 billion is outsourced to the contract services market. 

A central IRB is an "outside" or "independent" IRB. The central IRB serves to review research for non-IRB institutions, private practices, or outpatient clinical trials. Investigators conducting research in a noninshtutional setting often choose to use an established central IRB rather than forming their own. In addition, many hospitals and other instituhons are choosing to eliminate their internal IRBs and outsource this function. The benefits of the decision to outsource include ... 

Contract research organisations are likely to be more efficient, and on occasion can be faster than the company. A balance has to be struck between the outsourcing costs, internal costs (which are often underestimated) and the management requirements and skill sets of the CRO and internal staff. 

A dimension of the increasing disintegration of pharmaceutical R D is the growing use of contract research organizations (CROs) to conduct clinical trials of new drugs. By 1999, 23% of trials were outsourced to CROs (Azoulay 2004, pp. 1593,1600). In general, the more data-intensive projects are outsourced, while knowledge-intensive projects are more frequently undertaken within pharmaceutical companies (p. 1592). 

Pine Chemicals, Sifting for Gold (2001) (e.g.) Global healthcare equity research. Pharmaceutical Outsourcing Trends (e.g.)... 

There are different ways in which an ICS can be implemented, however. The example above is illustrative of an endogenous form of ICS where producers are actively involved in ICS management. At the other end of the spectrum is an exporter-led model, whereby a buyer organises producers and controls the ICS through the implementation of external guidelines to regulate the supply chain and outsourced farmers (Pyburn 2004). Further research is needed to better understand the impacts and dynamics of these different expressions of ICS. 

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... 

Enabling technologies, longer term and or fundamental research. These can all be outsourced but a company needs to retain enough internal intellectual capacity to be intelligent purchasers of the research and technology. 

The ability to analyse the compounds or materials coming out of a chemical laboratory or plant is an absolute essential. It is one of those disciplines that, when properly ran and designed to specifically meet the needs of a particular research, development or manufacturing area, can offer a very competitive advantage to the company. Therefore, the wholesale outsourcing of such a facility needs to be thought through very carefully. 

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