Tell us about your study

We’ll connect you with the right clinical
development team.

Our dedicated cardiovascular teams deliver:

  • 30+ years of dedicated CVM study experience
  • 400+ team members with cardiovascular expertise
  • 10-year average clinical project manager tenure. The team you meet is the team you keep.
  • 14 in-house medical monitors with cardiovascular experience

From early phase cardiovascular pharmacology studies to global registrational outcome trials — we help you start fast and scale without friction.

CVOT and Cardiovascular Outcome Trial Expertise

Cardiovascular outcome trials require large-scale global coordination, extended retention, and flawless MACE endpoint adjudication. Our teams have demonstrated capability in multi-country Phase III CVOTs, delivering lean, efficient execution without the operational drag that costs you months at larger CROs.

Deep CKM Syndrome and Comorbidity Expertise

Cardiovascular-kidney-metabolic syndrome represents the convergence of the most complex chronic disease pathways. Our teams design endpoints across the full CKM continuum, integrating cardiovascular safety, renal function, and metabolic outcomes into cohesive protocols. We understand the overlapping regulatory requirements and the emerging evidence linking these systems.

Agility That Matches Biotech Reality

Our CV sponsors may need to change direction mid-trial due to investor pressure, interim analyses, or M&A activity. We respond in days, not weeks. Our lean governance model enables rapid protocol amendments, ad hoc DMC/SRC support, and real-time pivots, without any bureaucratic delays.

Senior-Level, White-Glove Engagement from Start to Finish

Our CV sponsors consistently cite direct access to senior leadership as a key differentiator. The team at your bid defense is the team that runs your trial — not junior staff rotated in after the contract is signed. Our cardiovascular teams have long tenure and stable leadership, so you don’t lose institutional knowledge mid-program.

The Numbers Behind Our Cardiometabolic Track Record

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Patients Enrolled

5-year CVM portfolio

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CVM Studies

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Experienced CVM Sites

Global Network

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Years Avg PM Tenure

Full Cardiovascular Development Support

Start Fast. Scale Seamlessly. From first-in-human clinical pharmacology through global cardiovascular outcome trials and post-marketing commitments, we help you start your program fast and scale it without losing your team, your timeline, or your data integrity.

Phase I & Cardiovascular Clinical Pharmacology

  • FIH cardiovascular compound studies
  • SAD/MAD
  • PK/PD characterization for cardiac agents
  • Thorough QT (QTc) and cardiovascular safety studies
  • Drug-drug interaction studies
  • Bioequivalence studies
  • 200-bed clinical research unit (San Antonio, TX)
  • Integrated bioanalytical laboratory (2,000+ validated methods)

Phase II–IV & Global Cardiovascular Programs

  • CVOTs
  • Heart failure trials (HFpEF and HFrEF)
  • Hypertension and blood pressure management studies
  • MACE endpoint adjudication and clinical event committees
  • Multi-country regulatory submissions (FDA, EMA, PMDA)
  • Adaptive and complex trial designs
  • Long-term retention strategies for extended CV programs
  • Post-marketing safety and outcomes studies

Therapeutic Area Depth

  • Heart failure (HFpEF, HFrEF, acute decompensated HF)
  • Pulmonary arterial hypertension (PAH)
  • Acute coronary syndromes (ACS/MI)
  • Hypertension
  • Cardiovascular risk reduction
  • Gene Therapy
  • Atrial fibrillation and anticoagulant programs
  • Lipid disorders: HeFH, HoFH, Lp(a), hypertriglyceridemia
  • siRNA/genetic medicines for cardiovascular targets
  • Venous thromboembolism (VTE)
  • CKD and CKM syndrome
  • Cardiac amyloidosis, CPVT, and rare cardiovascular indications
  • CVOT design with MACE endpoint adjudication and DSMB management
  • Cardiac core lab coordination
  • PROs
  • Digital endpoints (actigraphy, wearables)

“We really appreciate the strong collaborative partnership we’ve developed with Worldwide which is based on shared accountability. I see us awarding them more studies in the future.”

Clinical Stage Biotech Company Sr. Vice President of Clinical Development and CMS

“It was an open, honest, but enthusiastic work environment that [Worldwide Clinical Trials] really provided. They paid attention to us as a small company…and they made us feel like one of their more important clients, even if we weren’t, and that was all the difference.”

Small Biopharmaceutical Customer Senior Vice President of Program Operations of Clinical Operations

“Worldwide Clinical Trials is focused on design and appropriate execution and reporting of clinical trial data. The mission is pretty clear…When you deal with big CROs, if we make a change in a process because we think that’s the right thing to do, it’s not enough for them just to do it because we want it. They’re less concerned about that at Worldwide…they’re more concerned about doing the right thing.”

Small Biopharmaceutical Customer Director of Clinical Operations

Who We Partner With in Cardiovascular

We understand that different CV sponsors have different pressures — and we’ve built our model around them.

Emerging CV Biotech

You’re developing a first-in-class cardiovascular compound — an ANGPTL3 inhibitor, a novel anticoagulant, or a gene therapy for inherited cardiomyopathy — and your investors need milestone data, not excuses about the CRO process. You need a CRO that compensates for a lean internal team, delivers senior attention from day one, and moves at the speed your funding demands.


Mid-Stage Biopharma Scaling CV Programs

You’re transitioning from proof-of-concept to a registrational CVOT and need a partner who can execute multi-country programs without the operational drag, staff turnover, and week-long governance cycles. You need global reach with biotech-speed decision-making, and a team that won’t disappear after the bid defense.


Pharma Cardiovascular Safety Programs

You need a cardiovascular CRO partner for the CV safety component of a metabolic, obesity, or diabetes program, or for a post-marketing cardiovascular outcomes commitment. We understand MACE adjudication, cardiovascular risk reduction endpoints, and the regulatory expectations for CV safety data in non-CV drug programs.

Alessandra Vignola

Senior Vice President, Cardiovascular & Metabolic

Seasoned pharmaceutical and clinical research leader with 30+ years experience guiding cardiometabolic programs across oncology, hematology, cardiovascular, endocrine, gastrointestinal, and immunology.

Monika Iten, PhD

Vice President Project Management, Cardiovascular

Vice President of Project Management with 18+ years’ experience leading global cardiovascular and metabolic clinical trials, driving performance and successful delivery.

Rafal Ziecina, MD, PhD

Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic

Executive Director of Scientific Solutions with 20+ years’ pharmaceutical research experience leading cardiovascular and metabolic initiatives, regulatory strategy, safety, and development planning.

MarieElena Cordisco, MA, APRN, NP-C

Senior Director, Therapeutic Strategy Lead, Metabolic

Clinical research leader and nurse practitioner with 20+ years’ experience in endocrinology and cardiometabolic trials, advancing patient-centered research and care.

Casey Ustick

Therapeutic Strategy Lead, Metabolic

Therapeutic strategy leader in metabolic programs, integrating science, operations, and commercial insight to guide successful clinical development strategies.

Michael Murphy, MD, PhD

Chief Medical and Scientific Officer

Former FDA reviewer with 15+ years in gene therapy development. Deep expertise in regulatory pathways.

Searching for the right CRO partner to help with your clinical development needs?

At Worldwide Clinical Trials, we deliver high-quality, reliable, and timely clinical trial services to help optimize the success of your projects. For the second year in a row, data from the Industry Standard Research (ISR) report showed that Worldwide Clinical Trials was the highest-rated Phase II/III CRO across several categories.