Cardiovascular CRO Solutions

Enabling Cardiovascular Innovation with Clinical Expertise

Specialized expertise in cardiovascular clinical research, delivering compliant, efficient trials across diverse cardiac and vascular indications with demonstrated regulatory success.

Talk to Our Cardiovascular Team
Cardiovascular

Your Partner in Advancing Cardiovascular Medicine

Our cardiovascular team combines extensive therapeutic expertise with operational excellence to navigate the unique complexities of cardiac trials. From endpoint selection to specialized site management and precise data monitoring, we deliver innovative and customized solutions that maximize development efficiency while maintaining scientific rigor and patient safety.

Our cardiovascular device and diagnostic studies routinely incorporate high-sensitivity cardiac troponin I (hsTnI), high-sensitivity cardiac troponin T (hs-TnT), and N-terminal pro b-type natriuretic peptide (NT-proBNP) as validated biomarkers for both safety and efficacy endpoints. We can manage clinical trials for a broad range of cardiovascular medical devices, including stents, angioplasty balloons, structural heart devices, catheters, and connected wearable monitors. These programs leverage our cardiovascular expertise, biostatistical rigor, and regulatory insight to streamline FDA and CE-mark submissions.

Strategic Trial Design for Cardiovascular Success

Our cardiovascular specialists design studies that address the unique challenges of cardiac research. We implement innovative approaches to patient selection, endpoint measurement, and risk mitigation while balancing scientific rigor with operational feasibility to maximize development efficiency.

  • Protocol optimization for cardiovascular-specific endpoints
  • Event adjudication committee management and Data Safety Monitoring Committees (DSMB)
  • Specialized ECG and imaging assessments
  • Risk-adapted monitoring strategies

Navigating Complex Cardiovascular Regulations

Our regulatory experts provide strategic guidance through evolving cardiovascular frameworks, from early development planning through approval and beyond. We navigate shifting standards for safety monitoring, endpoint selection, and benefit-risk assessment with a focus on regulatory efficiency.

  • FDA Division of Cardiovascular and Renal Products engagement
  • Cardiovascular safety requirements expertise
  • Global cardiac regulatory strategies
  • Cardiovascular device-drug combinations
  • Expedited pathway qualification
  • Advisory committee preparation

Advanced Analytics for Cardiovascular Endpoints

Our cardiovascular data teams specialize in the unique statistical challenges of cardiac research. We implement sophisticated approaches to endpoint analysis, safety signal detection, and real-world evidence generation to maximize the value of your clinical data.

  • Complex time-to-event analyses
  • Innovative cardiovascular endpoint methodologies
  • Centralized ECG/imaging data management
  • Cardiovascular safety signal detection
  • Quality of life measurement strategies
  • Real-world evidence integration

Quality Excellence for Cardiovascular Research

Our quality systems ensure the integrity of your cardiovascular trial data while maintaining operational efficiency. We implement tailored approaches to risk-based quality management with targeted oversight of critical cardiovascular endpoints and safety assessments.

  • Event adjudication process validation
  • Cardiovascular data standardization
  • Risk-based quality management systems
  • Third-party cardiac testing oversight
  • Regulatory inspection readiness

Cardiac Conditions

  • Coronary artery disease
  • Myocardial infarction
  • Heart failure (HFrEF, HFpEF)
  • Atrial fibrillation
  • Ventricular arrhythmias
  • Valvular heart disease
  • Cardiomyopathy
  • Myocarditis and pericarditis
  • Congenital heart disease
  • Cardiac arrest
  • Angina pectoris
  • Sudden cardiac death

Vascular Conditions

  • Peripheral artery disease (PAD)
  • Carotid artery disease
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism
  • Aortic aneurysm and dissection
  • Chronic venous insufficiency
  • Atherosclerosis
  • Thromboembolism
  • Renal artery stenosis
  • Mesenteric ischemia
  • Vascular malformations
  • Acute limb ischemia

Diagnostic & Biomarker Technologies

  • Cardiac troponin assays
  • B-type natriuretic peptide (BNP/NT-proBNP) testing
  • Lipid panel diagnostic systems
  • C-reactive protein (CRP) assays
  • Coagulation monitoring devices
  • Point-of-care cardiac biomarkers
  • D-dimer testing systems
  • Lipoprotein(a) assays
  • Inflammatory marker panels
  • Genetic testing for inherited conditions
  • Metabolic biomarker platforms
  • Risk stratification algorithms

Medical Device Applications

  • Electrocardiogram (ECG/EKG) systems
  • Holter and ambulatory monitoring devices
  • Cardiac imaging systems (echo, CT, MRI)
  • Vascular ultrasound platforms
  • Blood pressure monitoring devices
  • Cardiac catheterization equipment
  • Intravascular imaging systems
  • Hemodynamic monitoring devices
  • Remote cardiac monitoring platforms
  • AI-assisted diagnostic imaging
  • Wearable cardiovascular monitors
  • Digital health platforms for CVD management

Why Choose Beaufort for Cardiovascular Clinical Trials?

Beaufort combines scientific expertise with innovation to deliver compliant cardiology trials designed to accelerate breakthroughs in cardiac care.

  • Therapeutic Expertise

    Our cardiovascular teams bring a deep understanding of cardiac pathophysiology and treatment mechanisms.

  • Regulatory Insight

    We navigate evolving cardiovascular-specific regulatory requirements with strategic foresight.

  • Operational Excellence

    Our tailored processes address the unique challenges of cardiac trials, from endpoint measurement to site management.

  • Data Excellence

    We implement specialized approaches to cardiovascular endpoint analysis and safety monitoring.

  • Patient-Focused Strategies

    We prioritize participant experience to enhance recruitment and retention.

Diverse Patient Populations in Cardiovascular Research

Beaufort’s cardiovascular trials encompass patients across all demographics, disease severities, and comorbidity profiles. We excel at recruiting challenging populations, including elderly patients with multiple comorbidities, rare genetic cardiac disorders, and ethnically diverse communities. Our site selection strategies have proven particularly effective for studies requiring specific biomarker profiles, disease subtypes, and treatment histories.

Diverse Patient Populations in Cardiovascular Research

Cardiovascular Frequently Asked Questions

Get answers to common questions about cardiology-focused trials and clinical research services.

As a cardiovascular CRO, we implement multi-layered pre-screening protocols incorporating medical history algorithms and targeted referral network development. Our approach includes site-specific enrollment forecasting models, pre-identification of eligible patients through EHR review, and ongoing enrollment performance analytics to continuously refine recruitment tactics.

Our specialized teams establish rigorous event adjudication committees with standardized operating procedures, comprehensive training programs, and consistent documentation templates. We implement secure, validated platforms for blinded event package preparation and review, with quality oversight processes to ensure consistent adjudication across all trial sites.

Our teams have successfully managed numerous CVOTs for diabetes, weight management, and anti-inflammatory therapies. We implement efficient centralized event collection systems, targeted site selection strategies, and specialized training programs focused on cardiovascular event identification and documentation to maximize event capture while maintaining cost efficiency.

We deploy comprehensive retention strategies including personalized follow-up schedules, decentralized visit options, patient engagement technologies, and site-specific retention incentive programs. Our approach emphasizes burden reduction, ongoing participant education about study importance, and flexible follow-up methodologies to maintain a connection with study participants.

We implement tailored cardiovascular safety monitoring plans incorporating centralized ECG analysis, standardized QT interval measurement, proactive monitoring for heart failure signals, and customized data review schedules. Our medical teams provide ongoing site education on cardiac adverse event identification and management, with expedited review processes for potential cardiac safety signals.