By Kirsten Colling, Senior Director Global Operations, Bioclinica Post-Approval Research
Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research. Companies frequently apply the same rigor and processes to post-approval research that are used in pre-market studies designed for the registration of a new drug or device. Companies ought to leverage strategies, processes, standard operating procedures (SOPs), and technologies that are specifi cally designed for and more relevant to post-approval research.