Operations
Standardized and adjudicated high-quality data are a cornerstone of modern research. In cardiovascular medicine, significant information about the outcomes of an investigational therapy is derived from diagnostic techniques. To ensure unbiased (often blinded), highly reproducible, standardized analysis of these diagnostics tests, core laboratories have been born. They are specialized in handling large volumes of data collected from diverse investigational sites with uniform methodology and without prior knowledge of the outcome. These rigorous analytical conditions are to eliminate as much bias as possible and provide as much objective and reliable measure of performance as possible.
The Core Image Analysis Laboratory of KCRI focuses on the angiographic and intravascular ultrasound data as they are the golden standard in interventional cardiology. The Laboratory unites the expertise of dedicated medical professionals (image analysts and physicians experienced in cardiovascular imaging) with computer-based cutting edge analytical techniques and rigorous environment of Good Clinical Practice guidelines. The Laboratory has been organized according to the standards adopted in the United States of America for data generation, analysis, compilation and transfer with the purpose of presenting the data to U. S. Food and Drug Administration (FDA) seeking approval of novel therapies for human use. As such, the Laboratory employs the FDA-approved software and follows the standard operating procedures that conform to the guidelines governing clinical research in the USA, most importantly Chapter 21 of the U. S. Code of Federal Regulations and Clinical Trials Directive of European Union issued in 2004.