Cardiovascular CRO

Learn how the experienced team at Medpace can help your cardiovascular drug or device clinical trial succeed.

Learn how the experienced team at Medpace can help your cardiovascular drug or device clinical trial succeed.

Specialized and Scientific Approach to Cardiovascular Clinical Research

Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality globally, prompting the need for safe and effective drugs and devices to treat these conditions. Clinical trials in this space require a specialized, scientific approach to help you anticipate challenges and navigate the path to success. At Medpace, our team of cardiovascular specialists are highly skilled in the scientific methodology, standard of care, evolving regulatory requirements and operational considerations that are necessary to bring drugs and devices that treat or prevent heart disease to market. Our extensive experience in cardiovascular studies and relationships with KOLs paired with our proven track record of success provide the knowledge and flexibility to adapt to the unique needs of each cardiovascular trial.

The Medpace Advantage for Cardiovascular Clinical Trials

Partner with Medpace to successfully overcome the complexities of cardiovascular clinical trials. We bring a global footprint, strategic medical, regulatory and operational leadership as well as fully integrated laboratories and core imaging services to accelerate cardiovascular studies.

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Cardiovascular CRO Capabilities

Since our inception in 1992, we have conducted hundreds of Phase I-IV cardiovascular trials helping to pioneer many of the preventative cardiovascular drugs and medical devices introduced in the past 30 years. We have supported studies from first-in-human Phase I in our Phase I Unit through proof of concept Phase 2 and dose-ranging Phase 2b, and pivotal cardiovascular outcomes trials (CVOT) – across broad indications and wide study groups. Our therapeutically-focused team has conducted studies including acute care setting, drug/device combination, large outcomes studies, thorough QT, as well as managing Clinical Endpoint Committees (CEC) and DSMB for numerous studies.

To position cardiovascular trials for success, we help our clients:

  • Effectively plan and conduct cardiovascular studies for drug/device and cardiac safety
  • Efficiently conduct large cardiovascular outcomes trials that demand rigorous safety requirements
  • Seamlessly integrate cardiovascular trials with cross-therapeutic projects, including nephrology and endocrine & metabolic

Integrated Global Central Labs

Medpace’s central laboratories have unparalleled experience and expertise in the development of lipid and cardiovascular modifying therapies. In fact, our central laboratory has conducted over 510 studies that included over 385k subject screenings, 125k sites managed, and 13k validated assays in this area.

Our PhD scientists are available to talk through your testing needs at an early stage to ensure the right biomarkers and methodologies are selected to avoid unnecessary (and costly) testing. We can support your programs from discovery and proof-of-concept through large, long term global lipid and cardiovascular trials.

Cardiovascular & ECG Core Lab

Our cardiovascular core lab provides the full spectrum of cardiovascular monitoring capabilities for clinical trials optimized for over 30 years, routinely collaborating with the Medpace CRO on managed studies requiring central core lab services.

We also offer integrated digital biometrics from wearables and remote devices into clinical study data. This collection of biosensor data can support digital endpoints and a more compelling regulatory case. This approach is supported for remote ECG recording by professional rhythm organizations such as the Heart Rhythm Society and European Heart Rhythm Association.

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Fact Sheet

Comprehensive Central Laboratory Services

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Robust Cardiac Safety Services

Conducting Thorough QT (TQT) studies implemented under ICH E14 guidelines requires an exceptional level of coordination and control. Medpace, with integrated services and cardiac safety experts all housed on the same clinical research campus, provides a distinct advantage for managing the rigors of TQT studies. Our drug development expertise coupled with an integrated approach to studying cardiac safety delivers complete control and greater efficiency for your study.

With the intense focus on cardiac safety from regulatory authorities, it’s important to entrust your TQT study to a highly qualified team that can provide the guidance and insights to move your product development forward. Early planning is especially critical. Medpace’s therapeutically-focused medical monitors, regulatory experts, clinical pharmacologists, and statisticians work collaboratively to review protocols and provide guidance for study design and regulatory submissions. This early involvement can lead to cost savings and efficiencies throughout the development cycle.

Cardiovascular Precision Medicine Program

The emerging role of precision medicine in the field of cardiovascular disease has become increasingly important, whereby investigational drugs and therapies are focused on a subphenotype of patients with disease and/or a molecular target, e.g., gene, transcript, or peptide, that is associated with a disease. To meet these changing needs Medpace has established a unique in-house Cardiovascular Precision Medicine Program — an extension of the cardiovascular therapeutic team — comprised of experts with extensive knowledge in the field of cardiovascular disease and precision medicine who aim to create a highly specialized partnership with industry sponsors seeking to develop therapies focused on disease subphenotypes and employ a patient-tailored approach.

Abstract Network Background

“The goal of precision medicine is to move away from population averages and medians and instead, focus on the subject’s individual unique phenotype, as well as response to treatment. With Medpace’s program, we are excited to work with Sponsors who are on the forefront of working on medical therapies that are based on precision medicine principles.”

Richard Lee, MD
Richard Lee, MD
Vice President, Medical Department, Cardiovascular Precision Medicine
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Cardiovascular Experts

Serving as therapeutic team leaders, our in-house medical doctors provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies together with our global regulatory affairs experts to provide strategic guidance on the best pathways to accelerate approvals. Our MDs are embedded throughout every study, providing greater depth of expertise and the ability to tackle complex and challenging diseases.

Our team of experienced advanced clinical practitioners (ACPs) support our medical and clinical operations teams, providing a  unique perspective and an additional layer of knowledge and insight to the clinical development team. These highly-trained experts with advanced degrees and hands-on clinical experience help streamline your studies and address potential challenges early in the study planning. Like our Medical Monitors, the ACPs are embedded in the study team to ensure your study is feasible and operationalized for efficient execution by looking at the protocol through the lens of the patient and site staff. ACPs also help with the review of safety events, ongoing team education, recruitment strategies, and study document review. Their understanding of what works in a clinical setting makes them a valuable part of our embedded medical expertise model.

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Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials