Cardiovascular Clinical Trials
While advances in cardiac imaging mean that sponsors have a growing number of modalities to choose from when planning a clinical trial, it can be difficult to plan a cardiovascular imaging strategy while managing often competing interests:
- Scientifically, you want to take advantage of modalities that offer the most sensitive and reliable data for your study
- In terms of staff and other resources, you need a cardiovascular imaging protocol that takes into account varied capabilities of diverse investigational sites
- From an enrollment standpoint, you want to employ the safest and most convenient cardiac imaging modalities for study subjects
- Financially, you want an imaging plan that won’t break the bank, and you need an accurate estimate of costs before enrolling your first subject.
Other imaging core labs may take any opportunity to maximize your imaging budget. With them, you might adopt a protocol that includes unnecessary and/or expensive modalities.
When you partner with Bioclinica for cardiac imaging support, you begin an ongoing relationship with our multidisciplinary team.
We always include scientific and budgetary experts in the discussion to make sure that your imaging plan will allow you to meet your milestones and match your resources. In the planning phase, our client services team always works with scientific and regulatory experts to develop protocol alternatives that maintain your trial’s integrity while keeping budgetary and timeline concerns in mind
Cardiovascular Imaging Team
Bioclinica’s scientific team is made up of highly qualified physicians and technicians who ensure quality throughout the cardiovascular research process, from study design to investigational site training and primary and confirmatory image analysis.
- Our specialists guide the protocol development process to ensure image quality and consistency from the outset
- We offer comprehensive investigational site support to maintain high levels of competency in the field
- The primary review of all images is conducted by registered sonographers trained in the rules for quality assessments and appropriate contours.
- Following the primary review, a physician over-read confirms all assessments
- Physicians conducting readings are certified with a subspecialty in cardiovascular medicine and specialty training in each required modality
- Our cardiac imaging team is actively involved in developing comprehensive reports to support the approval process
Cardiovascular Clinical Trial Experience
Expert Independent Review
Cardiovascular Imaging Modalities
Our independent reviewers have unrivalled experience with the latest advances in the evaluation of cardiac structure and function. Bioclinica’s specialists analyze all images from baseline through follow-up and support a wide range of imaging modalities.
Bioclinica’s experienced regulatory team participates in every step of the clinical trial process, providing expert guidance for FDA, EMA, PMDA and CFDA submission.
Learn more about Bioclinica’s regulatory expertise.
Our recent work includes imaging support for the following cardiac indications and areas:
- Atherosclerosis/Coronary Artery Disease (CAD)
- Cardiac Contrast Agents
- Cardiac Tissue Ablation
- Congenital Heart Disease
- Congestive Heart Failure (CHF)
- Deep Vein Thrombosis (DT)
- Duchenne’s Muscular Dystrophy
- Fabry Disease
- Giant Cell Arteritis
- HDL-C Levels
- Hunter Syndrome
- Medical Devices
- Myocardial Infarction (MI)
- Myocardial Perfusion
- Peripheral Vascular Disease (PVD)
- Primary Hyperoxaluria
- Pulmonary Hypertension
- Sickle Cell Disease
Bioclinica’s experience covers the complete range of imaging modalities for cardiovascular research, including:
- Quantitative Coronary Angiography (QCA)
- Quantitative Vascular Angiography (QVA)
- Computed Tomography Angiography (CTA)
- Tissue Doppler
- Strain Imaging
- Intravascular Ultrasound (IVUS) or US
- Magnetic Resonance (MR)
- Cardiac MR (CMR)
- Nuclear Cardiology
- Multiple Gated Acquisition (MUGA)
- Positron Emission Tomography (PET)
- Single Photon Emission Computed Tomography (SPECT)