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Cardiovascular Imaging

Cardiovascular Imaging Expertise

Advances in medical imaging offer clinicians and sponsors sensitive and quantitative measurements of cardiac structure and function. While these advances enable increasingly sensitive assessments of drug safety and efficacy, the success of your clinical trial depends on the selection and accurate measurement of cardiovascular endpoints.

Bioclinica's cardiovascular team has experience with all imaging modalities including the latest innovations in molecular imaging and echocardiographic strain, helping you design and support the evaluation of your drug or medical device.

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Cardiac Safety

The association of many oncology drugs with cardiotoxic side effects necessitates independent cardiac safety studies for therapies in development. Bioclinica has extensive expertise in cardiac safety including ICH-E14 mandated Thorough QT services, blood pressure analysis and more. Many times cardiovascular imaging services are also included to assess the impact of cancer therapy agents on cardiac structure and function early in clinical development.

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

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Bioclinica's Cardiovascular Therapeutic Strengths include:

      World leader in centralized imaging services, providing sponsors with comprehensive support for clinical trials across all major cardiovascular indications.

      Understand the complexities of imaging endpoints required for monitoring specific disease states.

      There are many cardiovascular imaging choices to consider and we will help sort through the technical requirements, acquisition challenges, costs and advise on the most appropriate endpoints for your clinical study.

Bioclinica's Cardiovascular Services include:

      Latest developments in imaging endpoints

      Qualitative and quantitative image analysis for all imaging modalities

      Full 21 CFR Part 11 compliance

      Protocols to maintain contact with the FDA to implement regulatory guidance

Bioclinica's Cardiovascular Modalities supported include:

Echocardiography

Cardiac MR

Nuclear Imaging

Cardiac CT

Angiography

Ultrasound

Cardiovascular Imaging Indications:

  • Heart Failure
  • Cardiotoxicity (Safety)
  • Cardiomyopathy
  • Atherosclerosis
  • Hypertension
  • Fibrosis
  • Ischemia
  • LV Dysfunction
  • Rare Diseases
  • Vascular Thrombosis
  • Prosthetic valves
  • Medical devices

Bioclinica’s application of SMART in Cardiovascular Imaging

Bioclinica advances clinical trials via SMART — a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt to analysis, to regulatory submission.

Cardiovascular Imaging Endpoints

Your trial depends on the selection and accurate measurement of cardiovascular endpoints. Our cardiovascular experts have experience with all modalities including the latest advancements in molecular imaging, allowing for an innovative solution for your trial endpoint requirements.

Modality Endpoints
Echocardiography (ECHO) Automated contour detection for analysis of segmental wall motion, left ventricular ejection fraction (LVEF), left ventricular mass, end-diastolic and end-systolic volumes
Computed Tomography Angiography (CTA) Measurements of aorta, iliac, and carotid arteries including lumen diameter, percent diameter stenosis, lesion length, and calcium scoring
Cardiac Magnetic Resonance Imaging (MRI) Measurements of global and regional left ventricular function including LVEF, left ventricular mass, wall motion, and wall thickening.  Measurements of myocardial perfusion, infarct size and viability.
Magnetic Resonance Angiography (MRA) Analysis of arteriosclerosis and evaluation of MRA contrast agents
Positron Emission Tomography (PET) Analysis of coronary artery disease Myocardial perfusion abnormalities Global and regional function of the ventricles
Single Photon Emission Computed Tomography (SPECT) Analysis of coronary artery disease Myocardial perfusion abnormalities Global and regional function of the ventricle
Multiple Gated Acquisition Scan (MUGA) Measurement of cardiac ejection fractions

High Quality Imaging Data

  • Rigorous quality control processes to ensure high quality data

  • Qualification of imaging sites

  • Monitoring site adherence to regulatory guidelines

  • Specification of imaging requirements

  • Hardware/software assessments

  • Protocol training and technical support

We track all patients enrolled in studies and all imaging data generated during the course of a clinical trial. Our expert technicians use innovative tools to deeply review, update, and assure compliance with clinical trial protocols and defined reading paradigms. This enables queries to be issued, tracked, and resolved. Our ICL collection management process is designed to detect early on any substandard image quality or violations of the imaging protocol.

Our imaging core lab collection management process includes:

  • Collect image data
  • Query sites for missing data
  • Translate/digitize image data
  • Image QA/QC
  • Image data query resolution
  • Archive for long-term storage
  • And more

Quantitative analysis backed by scientific expertise

Quantitative Analysis

Expert independent review of cardiovascular images and quantitative image analysis in support of novel therapeutics and medical devices. We apply state-of-the-art software to deliver reproducible, high quality data.

Evaluation of Cardiac Structure and Function

  • Ejection fraction, cardiac volumes and mass
  • Heart valve assessment
  • Myocardial perfusion (viability, infarct size, scar tissue)
  • GL, LV, RV, and LA Strain
  • Coronary Artery Calcium (CAC) scoring

With Bioclinica, you’ll receive powerful, comprehensive reporting services for sites and sponsors, which supports the management and review of data for clinical trials.

Gain access to real-time reports, such as:

  • Metrics reports

  • Project status reports

  • Custom client reports

  • Analysis results reports

  • Safety and eligibility reports

  • Billing reports

Bioclinica's transfer tools support a wide range of formats to meet client and project specifications — tools that enable clinical trial data delivery, including patient data and imaging data, to sponsors, external vendors, and partners.

LEARN MORE ABOUT THE SMART PROCESS

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ADDITIONAL RESOURCES

Medical Imaging Services for Clinical Trials

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LEARN MORE ABOUT THE SMART PROCESS

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Cardiovascular Imaging Expertise Sheet

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LEARN MORE OR SPEAK WITH OUR EXPERTS

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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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