CROs in Cardiology: Advancing Treatments for Heart Disease

Cardiovascular disease (CVD), especially stroke (myocardial infarction, MI) and ischemic heart disease (IHD), is the leading cause of mortality and disability worldwide. Global CVD prevalence has almost doubled from 271 million in 1990 to 523 million in 2019, with a corresponding increase in deaths attributed to CVD from 12.1 million to 18.6 million. In the U.S., CVD is the leading cause of death, and coronary heart disease (CHD) is the most common cause of CVD death. Approximately 697,000 people died from CHD in 2020 (of which 382,820 died from coronary artery disease (CAD). Since patients with a history of CHD have a higher risk for future cardiovascular events, clinical research that supports cardiovascular risk reduction is vital. With these findings comes an increasing need for more CROs in cardiology that can help scientists manage the ins and outs of complex clinical trials to advance cardiovascular treatments.

A summary of key clinical trials that advanced cardiology treatments in 2021 included:

  • interventional cardiology trials on new generation, novel stent technology, and new intravascular physiology strategies to guide revascularization in stable and unstable CAD
  • acute coronary syndromes (ACS) trials on out-of-hospital cardiac arrests (OOHCA), the impact of COVID-19 on ST-elevation myocardial infarction (STEMI) networks, and optimal duration/type of anti-platelet treatment
  • structural intervention trials on transcatheter aortic valve replacement (TAVR) and mitral, tricuspid, and pulmonary valve interventions
  • heart failure (HF) trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors, sacubitril/valsartan, and novel drugs for hypertrophic cardiomyopathy (HCM)
  • prevention trials on proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
  • electrophysiology trials on atrial fibrillation (Afib) screening, new evidence for rhythm vs. rate control strategies, and pulse field ablation, a novel energy source for Afib ablations

The following list consists of top CROs in cardiology advancing the fight against cardiovascular disease through innovative research and the development of new treatments.

Top CROs in Cardiology

When it comes to conducting clinical trials for cardiology, choosing the right Contract Research Organization (CRO) can make all the difference. A top-performing CRO can accelerate the drug development process, reduce costs, and ensure regulatory compliance. With that in mind, we have compiled a list of the top CROs in cardiology to help pharmaceutical companies, biotech, and researchers find the right partner for their clinical trial needs. These CROs have demonstrated expertise in conducting trials for heart disease and have a proven track record of success.

Duke Clinical Research Institute (DCRI)

The Duke Clinical Research Institute (DCRI) contract research organization (CRO) builds on the Duke Databank for Cardiovascular Disease (DDCD) to conduct clinical trials, including landmark cardiology clinical trials that have impacted the practice of cardiology and improved CVD patient outcomes. Founded in 1969, the DDCD is the longest-running procedure-based cardiovascular database that gathers clinical characteristics, cardiac catheterization results, and interventions for patients receiving treatment at Duke University Medical Center. The DCRI team of physician-scientists provides sponsors with thought leadership while practicing cardiologists partner with statistical and operational experts to design effective and efficient studies. In addition, the cardiovascular research team is committed to rapid knowledge dissemination and implementation of science. In the past, pioneering discoveries by the DCRI have resulted in updates to clinical guidelines of professional medical associations and critical decisions by regulatory bodies.

ICON

Founded in Dublin in 1990, ICON expanded to the UK, U.S., Germany, and Japan within its first six years of operation and now employs over 39,300 people. The ICON Cardiovascular CRO is a global full-service provider with over 25 years of experience conducting cardiovascular trials with an emphasis on key cardiovascular/metabolic indications. In the last five years, ICON conducted more than 660 cardiovascular studies involving over 710,000 patients across more than 28,700 sites. The CRO’s clinical research teams, which include experienced cardio-metabolic drug and medical device development teams, use a data-driven approach to run clinical trials efficiently. ICON supports clinical trials across multiple indications, including atrial and ventricular arrhythmia, cardiomyopathy, HF, hypertension (HTN), pulmonary HTN, CAD and stable angina, ACS, venous thromboembolism (VTE), and peripheral arterial disease.

IQVIA

IQVIA offers sponsors new options for cardiology clinical trials, including data and analytics, adaptive and novel trial approaches, innovative patient-centered trials using virtual and hybrid models, transformative technologies for site selection and patient recruitment, and technologies for risk-based monitoring. The CRO’s achievements include a proven track record in patient retention and preventing patients lost to follow-up (LTFU), and having all of the top 20 CVD drugs in 2019 developed with IQVIA support.

By indication, IQVIA:

  • has conducted 21 hyperlipidemia clinical trials with 19,000 patients in the past ten years
  • uses its Connected Devices platform to monitor blood pressure, electrocardiogram (ECG), and other wearables for HTN trials
  • was involved in all FDA-approved HF drugs between 2011 and 2019
  • followed 25,000 ACS patients in outcomes trials in the last ten years and achieved 98.3% patient follow-up
  • conducted 12 trials in arrhythmia and Afib involving 41,000 patients over the previous ten years
  • achieved 99% patient follow-up (with 0.005% LTFU and less than 1.2% withdrawn consent) in a large stroke prevention outcomes trial

Labcorp

Labcorp offers services for cardiovascular drug development from lead optimization through commercialization. The Labcorp Cardiovascular CRO’s team has dedicated cardiovascular specialists with academic and industry experience. The CRO’s focus is on tracking disease patterns in aging populations, staying abreast of the rapidly evolving marketplace, and having experience with small molecules, device-based therapeutics, and biologics.

Recognizing that the primary reason for late-stage cardiovascular drug failure is the inability to document improvement in outcomes, Labcorp works with sponsors early on – from the preclinical phase – to design outcomes-oriented studies. In addition, Labcorp partners with cardiovascular academic research organizations for medical and scientific leadership and insight into investigator and site quality. To improve patient recruitment, Labcorp has a proprietary database of site selection and clinical laboratory data.

Medpace

The Medpace Cardiology CRO is a full-service CRO specializing in the design and conduct of global trials. Since 1992, Medpace has conducted Phase IPhase IV cardiovascular clinical trials for drugs and medical devices involving nearly 50 countries and has pioneered preventative cardiovascular drugs and devices. Past studies include drug/device combination, large outcomes, thorough QT studies, and studies in an acute care setting.

The CRO’s promise to sponsors includes its global footprint and strategic medical, regulatory, and operational leadership. The team comprises board-certified cardiologists with academic clinical practice and drug development backgrounds, operational and regulatory teams with global experience in drug and device studies, and the dedicated Medpace Medical Device team. The Medpace ECG Core Laboratory provides reliable, consistent, and timely electrocardiographic services. Medpace has experience in ACS, HTN, stroke, HF, atherosclerosis, Afib, STEMI, and non-STEMI indications.

ProTrials Research, Inc.

ProTrials Research, Inc. is a CRO headquartered in the U.S., with ClinOps personnel worldwide. ProTrials provides the pharma, biotech, and medical device industries with site management, clinical monitoring, project management, and supportive clinical development services. The ProTrials team is experienced in managing and monitoring cardiovascular trials, including all phases of drug development and device trials. Trial sizes have ranged from one to over 700 sites, involving 10 to more than 7,000 subjects globally. Ninety-eight cardiovascular projects with more than 23 indications have been conducted. More than half of ProTrials employees (64%) have cardiovascular experience.

ProTrials is experienced in a broad range of indications, including ACS, acute myocardial infarction (AMI), angina pectoris, arrhythmia, arterial closure, Afib, cardiac catheterization, cardiac imaging, congestive HF, Coronary Artery Bypass Graft (CABG), HCM, myocardial perfusion imaging, paroxysmal supraventricular tachycardia, percutaneous coronary intervention, peripheral arterial occlusive disease, peripheral vein grafts, pulmonary arterial hypertension (PAH), thrombosis, vascular stent, and VTE.

Syneos Health

The Syneos Health Cardiology CRO recognizes and is experienced in the intricacies of running global cardiovascular outcomes trials (CVOT). It offers its sponsors access to a team with medical leadership, project management, ClinOps, pharmacovigilance, and statistics with CVOT experience. Cardiovascular clinical trials and research include new therapies such as stem cells, HFpEF, HFrEF, SGLT-2 inhibitors, and large, global CVOTs.

Syneos Health supports clinical trials across multiple indications, including ACS, angina pectoris, arrhythmias, cardiothoracic surgery, deep vein thrombosis (DVT), diabetes, dyslipidemia, HF, HTN, hyperlipidemia, IHD, obesity, peripheral arterial disease, pulmonary HTN, renal failure, and VTE. Syneos Health utilizes its web-based electronic endpoint adjudication system to capture high-quality clinical data, which is specially tailored for long-term, large-scale, global cardiovascular clinical trials and research.

Worldwide Clinical Trials

Founded by physicians committed to advancing medical science, Worldwide Clinical Trials has more than 2,000 employees overall. It has infrastructures in more than 60 countries and offices in North and South America, Eastern and Western Europe, Russia, and Asia. Worldwide has more than 30 years of experience in cardiovascular research and global trial experience in all phases of research. Cardiovascular experience includes ACS, angina, anticoagulation, atherosclerosis, Afib, cardiac arrhythmias, CAD, HF, HTN, IHD, myocardial infarction, PAH, restenosis, stroke/cerebrovascular disease prevention, and thrombosis.

Worldwide has award-winning, specialized cardiopulmonary teams which help emerging and established biopharma, biotech, and pharma companies test, validate, and de-risk the process of developing improved treatments for PAH. Worldwide offers patient-interfacing technology (when appropriate) for PAH trials, a novel FDA-approved randomized withdrawal model, and nuanced regulatory submissions.

Vial Cardiology CRO

Vial Cardiology CRO is a technology-powered contract research organization (CRO) headquartered in San Francisco, CA. Vial has an experienced team of ClinOps personnel worldwide and renowned scientific advisors who provide thought leadership to deliver faster, more efficient, and affordable clinical trials in cardiology and several other therapeutic areas. The CRO’s mission is to enable scientists in discovering revolutionary scientific treatments that enhance people’s overall well-being.

The next-generation CRO’s contemporary and user-friendly technology platform integrates multiple processes, including trial onboarding, patient enrollment, site communication, and data collection, into a unified system. Vial is experienced in working with small biotech and startup drug development companies and is ready to partner to meet their unique needs. Vial offers sponsors fixed-fee pricing agreements without change orders, dramatically reducing costs.

Vial is committed to creating a more efficient future for clinical trials by leveraging technology at every stage. Their technology-forward approach enhances speed and reduces costs, benefiting innovative biotech companies of all sizes.

CROs in Cardiology Clinical Research

In conclusion, CROs play a crucial role in advancing treatments for cardiovascular disease. Duke Clinical Research Institute, ICON, and Vial are a few of the CROs conducting cardiology clinical trials to support the fight against cardiovascular disease. These CROs use data-driven approaches, innovative patient-centered trials, and transformative technologies to conduct cardiology clinical trials efficiently.

Looking for a CRO to support your next cardiology clinical trial? Contact a Vial team member today to learn how we can provide faster, better, and cheaper trials.

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