Core Laboratory Analysis and Committee Management

Over the past two decades, the Yale Cardiovascular Research Group has been involved in the core laboratory analysis of hundreds of clinical trials. The team contributes to the development and validation of analysis tools and methodologies for multiple imaging modalities.

YCRG also manages Clinical Events Committees and Data Safety Monitoring Boards to generate standardized outcomes data and oversee the ethical conduct of ongoing trials at the highest level of quality.

The Angiographic Core Laboratory provides independent quantitative and qualitative assessment of coronary, peripheral, neurovascular, and venous angiograms using validated endpoints.

The Echocardiographic Core Laboratory provides state-of-the-art echocardiographic imaging interpretation and analysis, with extensive experience in the evaluation of echocardiographic measures for national and international multi-center clinical trials.

Examples include:

• Assessment of cardiac structural and valvular morphology and function in a wide range of interventions
• Analytic measures critical to the evaluation of acute myocardial infarction in the context of clinical trials.

The Intravascular Imaging Core Laboratory provides state-of-the-art intravascular imaging interpretation and analysis, including the latest technologies in intravascular ultrasound, optical coherence tomography, and near-infrared spectroscopy. The team has extensive experience in the analysis of validated endpoints, as well as the development of novel analysis tools and metrics for the assessment of diagnostic and therapeutic intravascular technologies.

The Physiology Core Laboratory uses commercial and customized software solutions for high-quality and accurate assessment and interpretation of pressure-wired based epicardial coronary indices such as fractional flow reserve (FFR) and non-hyperemic pressure ratios (iFR, RFR, DFR, DPR, dPR), doppler and thermodilution coronary flow data, microcirculation indices, and computational processing of physiology based on angiographic (QFR, ?FR), intravascular ultrasound (UFR), and optical coherence tomography (OFR) images.

The Duplex Vascular Ultrasound (DUS) Core Laboratory provides state-of-the-art DUS analysis and interpretation for clinical trials including FDA and other regulated approval studies. The team has expertise in cerebrovascular and peripheral vascular systems for multicenter clinical trials spanning national and international geographies. This includes:

• Superficial femoral arteries, below-the-knee, carotid, AV fistulae disease
• Anatomical evaluation of luminal morphology, pre- and post-device or standard of care intervention; plaque characteristics, obstructions, and occlusions
• Color flow and spectral Doppler evaluation of vascular flow hemodynamics with and without stenosis.

The Wound Core Laboratory provides standardized assessment of wound severity, dimensions, and healing to meet regulatory requirements for pivotal trials of peripheral arterial disease treatments.

The Yale Cardiovascular Research Group offers clinical events committee organization and implementation to independently adjudicate clinical events, conforming to regulatory requirements within single- or multicenter, national, or international clinical trials. YCRG works with trialists experienced in the full spectrum of cardiovascular disease who are familiar with contemporary scales and definitions common to a variety of drug and device clinical trials.

YCRG organizes and implements comprehensive data safety monitoring boards to ensure the ethical conduct of clinical trials to protect the rights and safety of enrolled patients. This includes:

• Documentation of all committee meetings
• Administrative and communication support between the sponsor, contract research organization, biostatistics, and data safety board members.