Cardiovascular

Cardiovascular Imaging Expertise

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Experience Across Cardiovascular Indications

Our team has provided imaging CRO services on Phase I-IV drug and device trials across Cardiovascular indications, including:

  • Acute and Chronic Heart Failure
  • Acute Coronary Syndromes
  • Acute Peripheral Arterial Occlusion
  • Aneurysms
  • Atrial Fibrillation
  • Cardiac Surgery
  • Carotid Artery Disease
  • Congestive Heart Failure
  • Coronary Artery Disease
  • Fabry Disease
  • Myocardial Infarction
  • Pulmonary and Arterial Hypertension

Modalities

We have extensive experience with Cardiovascular studies in the U.S. and Europe involving the following modalities:
  • Angiography
  • CT
  • CTPA
  • Echo
  • MRA
  • MRI
  • PET and SPECT Myocardial Perfusion Imaging
  • Pulmonary Angiography
  • Transesophageal Echocardiograms (TEE)
  • Ultrasound
  • V/Q Lung Scan
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Evaluation Criteria Expertise

We have experience with a variety of cardiovascular evaluation criteria, including:

  • CAC Scoring
  • Cardiac Morphology & Function
  • Clip Placement
  • Diastolic Pulmonary Artery Pressure
  • Echo Assessments (Doppler, 2&3D Structure and Function, and Contrast Enhancement)
  • Echo Peak TR Velocity
  • Indirect Fick Cardiac Output (CO)
  • LAA Assessments
  • Lateral & Septal E/e’ Ratio
  • Lateral & Septal e’ Velocity
  • Left Atrial (LA) Volumes/Index
  • Left Atrium Area & Diameter
  • Left Atrium Longitudinal Strain
  • Left Ventricle Ejection Fraction (LVEF)
  • Left Ventricle end-diastolic volume (LVEDV)
  • Left Ventricle end-systolic volume (LVESV)
  • Left Ventricle Mass
  • Left Ventricle Outflow Tract Stroke Volume
  • Left Ventricle Septal/Posterior Wall Thickness
  • Left Ventricular End Diastolic Pressure (LVEDP)
  • Left Ventricular Longitudinal Strain
  • Mean pulmonary artery pressure (mPAP)
  • Mean right atrial pressure (mRAP)
  • On-Study Incidental Findings
  • Percentage of PV Stenosis
  • Pulmonary Artery Pressure and Right Arterial Pressure
  • Pulmonary Artery Wedge Pressure (PAWP)
  • Quantitative Evaluation of PV and Stenosis
  • Right Main PA Pulsatility
  • Right Ventricle Ejection Fraction (RVEF)
  • Right Ventricle End-Diastolic Volume (RVEDV)
  • Right Ventricle End-Systolic Volume (RVESV)
  • Right Ventricle Fractional Area Change & Tissue Doppler s’ Velocity
  • Right Ventricle Global Longitudinal Strain (RVGLS)
  • Right Ventricle Mass
  • Right Ventricle Stroke Volume (RVSV)
  • Right Ventricle: Left Ventricle Dimension Ratio & Area Ratio
  • Right Ventricular Free Wall Strain
  • Right Ventricular Outflow Tract Acceleration Time & Outflow Tract Notch Presence
  • Safety Assessments
  • Systolic Pulmonary Artery Pressure
  • Thermodilution CO
  • Tricuspid Annular Plane Systolic Excursion
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Read Team

Our dedicated team of cardiologists and radiologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring. Our services also include safety monitoring. experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.

Reader Training

Through a combination of our expert radiologists and our rigorous training and testing regimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review. Sponsors have the flexibility of working with our highly-trained in-house radiologists, with sub-specialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor’s choice.
Expert radiologists during rigorous training
Experts working with sponsors

Study Design

Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.

Web-Based Technology Platform

Our state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by radiologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system.

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A Woman With Regulatory Experience

Regulatory Experience

We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards.

To Benefit From Our Cardiovascular Imaging Expertise

Please contact us today

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