is a privately owned and operated investigational site specializing in phase II, III and IV clinical trials for the pharmaceutical and biotechnology industries. CRC operates as an independent research center solely dedicated to conducting clinical trials in a broad array of specialties; including psychiatric, general medicine and sleep.
“Our approach is uncompromising; we exceed sponsor expectati
ons for reliability and dependability, subject enrollment, human protection and overall performance.” -Stacy Malm, President
Before a new medication can be prescribed or sold over the counter it must be approved by the Food and Drug Administration or FDA. In order for the FDA to approve a medication, the pharmaceutical company must show that the medication is both safe and effective for use in the treatment for which it is intended. To show this efficacy and safety the pharmaceutical company will spend many years conducting a series of studies. The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time. Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
