Before a pharmaceutical drug can be approved by the FDA for use in the United States, it must go through several phases of testing, called clinical trials.
During the clinical trial process, the potential drug is tested for safety and effectiveness. Volunteers are followed very closely by the doctor running the trial, called the Principal Investigator. Most clinical trials require regular office visit and more frequent medical test such as blood draws, ECGs, or physical exams. In addition, patients are often asked to keep careful record of changes to their health.
After receiving permission from the FDA, the clinical trials begin. Each drug goes through the following phases of testing:
Ninety-percent of drugs that reach Phase III go on to final evaluation by the FDA to seek approval for public use. Though the process takes many years, the end result of new, more effective treatments options makes the effort worthwhile.
The Alliance for Multispecialty Research, LLC (AMR) performs phase I, II, III, and IV clinical research trials to support pharmaceutical companies in the development of new drugs, devices, and vaccines. AMR includes 15 locations and 2 affiliated member centers across the continental United States, 126 investigators, over 7,749 previous clinical trials, and access to databases of over 657,344 patients. As one company, AMR now offers improved efficiencies with the same exceptional quality and industry professionals you trust.
Please visit amrllc.com for more information.