There are many safeguards in place that all research organizations must follow when conducting clinical trials. At CenExel, we proudly adhere to these safeguards and take additional steps to ensure participant safety and comfort.

The Food and Drug Administration (FDA) is the regulatory agency that oversees all clinical research conducted in the United States. It is their responsibility to protect the rights and, as much as possible, the welfare of subjects participating in clinical trials. The FDA reviews the data collected from clinical trials because  they ultimately determine whether a new treatment should be sold in the U.S. Several organizations and individuals are governed by FDA regulations including clinical investigators, pharmaceutical sponsors (the companies developing the treatments), Contract Research Organizations (companies that help conduct the studies), and Institutional Review Boards (groups that are responsible for ensuring the safety and welfare of study participants).

Good Clinical Practice (GCP) guidelines are industry guidelines designed to protect the safety of trial subjects. These guidelines encompass federal regulations and industry-accepted standards that govern clinical trials. These regulations and standards apply to the conduct of the studies, record keeping, informed consent of subjects, collection of scientific data, and submission of information needed for the FDA to determine whether a new treatment should be sold in the U.S. All research organizations must follow these guidelines when conducting clinical research.

An Institutional Review Board (IRB) is a committee that is formally tasked by an institution to review, approve, and monitor research involving human subjects. IRBs ensure that the risks to subjects are minimized; that subjects are adequately informed about the trial and the implications it will have on their treatment; that study protocols are modified, when necessary, to ensure safety; that risks are reasonable in relation to the anticipated benefits and the importance of the knowledge to be gained; that subject selection is equitable and that no classes of patients are discriminated against; that informed consent is obtained; that there is a provision for safety monitoring in the research plan; and that there are adequate provisions for the privacy and confidentiality for subjects and the data collected.