Clinical Trials

Pre-Clinical Research

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Pre-clinical research also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety data is collected. The main goals of pre-clinical studies are to determine the safe dose for First-in-man study and start to assess product's safety profile. Products may include new or iterated or like-kind medical devices, drugs, etc.

A study of 10 major countries that are major sources of preclinical outsourcing suggested that spending on preclinical outsourcing is increasing every year. In 2014, total outsourcing spending accounted for 13.8% of total preclinical spending, with in-house spending accounting for the remaining 86.2%. Countries such as India and China are able to provide a cost advantage of 50% to 60%, making them attractive destinations for preclinical research outsourcing. &D spending on pharmaceuticals in the U.S. has increased from $21.9 billion in 1996 to $65.3 billion in 2009, while NDA/BLA approvals decreased from 53 in 1996 to 25 in 2009. The ever-increasing cost of drug development in the U.S. is driving large pharmaceutical companies to outsource preclinical work to low cost countries such as India and China. Large pharmaceutical companies based in the UK, France, Germany and Switzerland, also account for a large share of preclinical outsourcing.