What about volunteer safety?

  • All clinical studies are conducted according to the International Conference on Harmonization’s (ICH) Good Clinical Practice standards and other applicable laws and regulations.
  • Clinical studies can only be conducted after receiving permission from the Food and Drug Administration (FDA), who judges the acceptability of each study based on pre-clinical research data such as the data from animal studies.
  • Clinical studies are conducted under the watchful eye of qualified doctors, nurses and other medical staff members, and ICRC itself is located in close proximity to the emergency services available at Monmouth Medical Center (MMC). Furthermore, the experienced panel of experts on the Institutional Review Board (IRB) must approve the medical site and the investigator (the doctor in charge of the study) before it can begin.
  • In the initial Phase I studies, volunteers receive a relatively small amount of the investigational drug, and are regularly examined at predetermined time points to ensure safety. If necessary, volunteers are able to receive timely treatment.