funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study. Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research. The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials. In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials. Phases Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in the general population. Phase IV is post-approval studies. Phase I includes 20 to 100 healthy volunteers or individuals with the disease or condition. This study typically lasts several months and its purpose is to prove safety and an effective dosage. Phase II includes a larger number of individual participants in the range of 100–300, and Phase III includes some 1000-3000 participants to assess efficacy and safety of the drug at different doses. Only 25-30% of drugs advance to the end of Phase III. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies. See also Clinical research