Cardiovascular CRO: Expert Clinical Trial Services for Heart Disease & CVOT
Cardiovascular disease remains the leading cause of death in the United States and worldwide, affecting hundreds of millions of patients across conditions including heart failure, atrial fibrillation, coronary artery disease, hypertension, cardiomyopathy and dyslipidemia. As a global leader in cardiovascular drug development and a specialized cardiovascular CRO, Syneos Health works with innovative companies at the forefront of cardiovascular therapies. This includes small to midsize biotech companies that turn to our dedicated cardiovascular team for deep cardiology therapeutic expertise and a flexible, creative approach to solving the most complex development challenges.
Whether you are designing a first-in-human cardiovascular study, managing a complex cardiovascular outcomes trial (CVOT) or navigating the dual regulatory requirements of the FDA and EMA, our cardiovascular team provides the depth and flexibility to match your program’s unique challenges.
Expertise that Moves Cardiovascular Therapies Forward
In a recent 5-year period, Syneos Health has helped develop or commercialize a significant amount of novel new cardiovascular therapies (2021-2025):
100%
approved by the FDA
83%
approved by the EMA
Cardiovascular Indications: Breadth and Depth Across the Spectrum
Our cardiovascular team has managed complex clinical programs across the full spectrum of cardiovascular indications and therapeutic modalities. This breadth of experience enables us to anticipate trial design challenges, regulatory hurdles and patient enrollment complexities before they arise.
Indications we support include:
- Atrial fibrillation and other arrhythmias
- Cardiomyopathy and structural heart disease
- Cardiovascular outcomes trials (CVOTs) for anti-diabetic, anti-obesity and novel metabolic agents
- Dyslipidemia and lipid-lowering therapies
- Emerging modalities including stem cell therapies, gene therapies and RNA-based cardiovascular treatments
- Heart failure, including HFpEF (heart failure with preserved ejection fraction) and HFrEF (heart failure with reduced ejection fraction)
- Hypertension and pulmonary arterial hypertension
- Ischemic heart disease and acute coronary syndromes
- SGLT-2 inhibitors and GLP-1 receptor agonists, and novel Nutrient-Stimulated Hormone (NuSH) therapies with cardiovascular endpoints
- Thrombosis and anticoagulation
Ready to see what our cardiology team can do for you?
Cardiovascular Outcomes Trial (CVOT) Expertise
CVOTs are among the most operationally complex and scientifically demanding studies in clinical research. They require large patient populations, multi-year follow-up periods, rigorous endpoint adjudication and alignment with evolving FDA and EMA guidance on cardiovascular risk assessment for new molecular entities.
Syneos Health has run many large, global CVOTs. Our CVOT capabilities include endpoint adjudication committee (EAC) support, independent data safety monitoring boards (DSMBs), adaptive trial design and global site activation strategies that prioritize enrollment speed without sacrificing data quality. We have specific experience managing CVOT requirements for anti-diabetic and anti-obesity drugs, where regulatory agencies require demonstration of cardiovascular safety or superiority as a condition of approval.
Cardiovascular, Renal and Metabolic Capabilities: Integrated Therapeutic Expertise at the Cardiometabolic Interface
The intersection of cardiovascular and metabolic diseases represents one of the most active and consequential frontiers in drug development today. Conditions such as type 2 diabetes, obesity, dyslipidemia, metabolic dysfunction-associated steatohepatitis (MASH) and metabolic syndromes are significantly associated with increased cardiovascular risk. The novel therapies designed to address them increasingly require integrated expertise that spans multiple therapeutic disciplines.
The Syneos Health cardiovascular team works in close collaboration with our endocrine and metabolic clinical trials specialists to support a full range of cardiometabolic programs. This includes cardiovascular outcomes trials (CVOTs) for anti-diabetic and anti-obesity agents, trials evaluating SGLT-2 inhibitors, GLP-1 receptor agonists and Nutrient-Stimulated Hormone (NuSH) therapies with cardiovascular primary or secondary endpoints, studies targeting metabolic dysfunction-associated steatohepatitis (MASH) with cardiovascular risk reduction objectives and programs investigating novel lipid-lowering therapies such as PCSK9 inhibitors, Lipoprotein (a) or Lp(a) therapeutics and RNA-based approaches. Our cross-therapeutic model means that sponsors developing therapies at the cardiovascular-metabolic interface benefit from unified trial design expertise, shared site networks with cardiometabolic patient populations and integrated regulatory strategy, from early Phase II feasibility through pivotal outcomes studies.
This integrated capability is especially relevant as regulatory agencies continue to require cardiovascular safety data for metabolic drugs and as the pipeline of GLP-1- and Nutrient-Stimulated Hormone (NuSH) based therapies expands to include cardiovascular-specific indications.
A Global Cardiovascular Site Network Built for High Performance
High-quality site selection is an important driver of cardiovascular trial performance. Syneos Health has built a dedicated global network of more than 2,200 sites with proven cardiovascular specialization — sites we know, that know us and that consistently meet enrollment targets and maintain data quality standards.
Our site relationships span academic medical centers, cardiometabolic research centers of excellence, community cardiology practices, heart failure clinics and electrophysiology programs across North America, Europe, Asia-Pacific and Latin America. We match each site’s specific patient population, investigator experience and infrastructure capabilities to your protocol requirements, with particular attention to inclusion/exclusion criteria that can make or break enrollment projections in cardiovascular studies.
For sponsors seeking site performance data before committing to a network, our feasibility automation platform (StudyEngage) enables data-driven site identification and activation planning.
Patient-Centered Cardiovascular Solutions: Reducing Burden, Improving Retention
Patients living with cardiovascular disease often face significant comorbidities and mobility challenges that make participation in traditional clinical trial models difficult. We design cardiovascular studies with the patient experience as a primary consideration, deploying decentralized and hybrid trial solutions, including home health nursing, remote monitoring, wearable cardiac devices and telemedicine, to bring the trial to the patient.
Our patient engagement methodology begins with patient journey mapping, ensuring that trial design and protocol burden are evaluated from the patient’s perspective before the study launches. The result is improved enrollment rates, better retention and more diverse patient populations that reflect the real-world burden of cardiovascular disease.
Regulatory Strategy for Cardiovascular Clinical Studies
Successful cardiovascular drug development requires a regulatory strategy that anticipates agency expectations at every phase. Our regulatory affairs team has deep familiarity with FDA guidance documents governing cardiovascular drug development, including guidance on evaluation of cardiovascular risk in endocrinology, diabetes and metabolism therapeutics, hypertension endpoints and requirements for large cardiovascular outcomes studies.
We support sponsors navigating FDA and EMA alignment, preparing cardiovascular-specific sections of INDs and NDAs, designing studies to meet REMS requirements where applicable and engaging with agency advisors on novel endpoint strategies for conditions such as HFpEF, where the traditional mortality endpoint may not be the most clinically meaningful measure.
Decentralized and Hybrid Cardiovascular Trials
Digital health technologies are transforming what is possible in cardiovascular clinical research. Remote cardiac monitoring, implantable loop recorders, digital ECG acquisition and connected weight and blood pressure monitoring enable continuous, high-fidelity data collection outside of traditional site visits, reducing patient burden while improving data completeness.
Syneos Health combines deep cardiovascular science expertise with proven decentralized trial capabilities to design and execute hybrid studies that optimize both data quality and patient accessibility. Our decentralized cardiovascular trial approach has been particularly effective in heart failure programs, where frequent in-person visits can be burdensome for patients with limited functional capacity.
Taking studies to where the patients are
Digital health technologies have the potential to increase efficiency and data capture, while creating exciting new ways to accelerate patient access, improve retention and increase diversity. We combine deep insights, agile technologies, innovative trial design experience and operational excellence to bring clinical trials closer to the patient.
A cardiovascular contract research organization (CRO) is a specialized clinical research partner that provides the scientific expertise, operational infrastructure, and global site networks needed to design, manage, and execute clinical trials in cardiovascular medicine. As a cardiovascular CRO, Syneos Health supports biopharma and biotech companies through all phases of drug development, from Phase I safety studies through large Phase III cardiovascular outcomes trials. We also provide regulatory affairs, data management and commercialization support.
Syneos Health has conducted many large-scale, global cardiovascular outcomes trials, including CVOTs for anti-diabetic agents (SGLT-2 inhibitors, GLP-1 receptor agonists), lipid-lowering therapies and heart failure treatments. Our CVOT capabilities include endpoint adjudication committee support, independent DSMB management, adaptive trial design and FDA/EMA regulatory alignment strategy.
In a recent five-year period, Syneos Health supported a significant number of novel cardiovascular therapies through clinical development and commercialization with a 100% FDA approval rate and 83% EMA approval rate for those supported programs. These results reflect our team’s deep therapeutic knowledge, proactive risk mitigation capabilities and global operational execution.
Syneos Health maintains a global network of more than 2,200 sites with specialization in cardiovascular studies. These sites span academic medical centers, community cardiology practices, heart failure clinics, and electrophysiology programs across North America, Europe, Asia-Pacific and Latin America. Site selection is supported by our feasibility automation platform, StudyEngage, which enables data-driven site identification and performance benchmarking.
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