Cardiovascular CRO Services

Complex Global CV Trials, Delivered With 30 Years of Institutional Experience

Worldwide delivers complex global CV trials across CVOT, heart failure, PAH, lipid-lowering siRNA, and hypertension, led by experienced teams built for the scale and duration of CV outcomes programs.

30 Years of CV Experience, Built for the Programs That Demand Precision

Worldwide’s cardiovascular portfolio spans long-duration CVOTs, specialist-access PAH programs, novel genetic medicines, and complex heart failure populations, with 150+ CVM trials of institutional experience behind every program.

Institutional Experience That Compounds Over Decades.

30+ years of CV delivery has built site relationships, regulatory history, KOL networks, and adjudication infrastructure that come from programs run at the highest level of complexity.

Senior-Led Teams Built for Multi-Year Outcomes Programs

The same senior team that wins Worldwide’s CV programs delivers them, with continuity sustained across the full duration of every program.

Operational Methodology Built for Complex Global CV Delivery

Worldwide’s CV operational methodology combines national leads, patient pathway understanding, central-laboratory back-up strategy, and early, hands-on site engagement site engagement to sustain execution quality across the full life of every program.

Specialized Cardiovascular CRO Across Phases, Indications, & Modalities

Heart Failure:

  • HFrEF
  • HFpEF
  • Acute Heart Failure
  • Chronic Heart Failure
  • Hospitalized Decompensated Heart Failure
  • Heart Failure with T2D
  • Heart Failure with CKD

Lipid Disorders & Genetic Medicines:

  • siRNA: ASCVD, LDL-C, HoFH, HeFH, Lp(a), Hypertriglyceridemia

Hypertension:

  • Essential Hypertension
  • Moderate-to-Severe Hypertension
  • Non-Responder Hypertension
  • Resistant Hypertension
  • Hypertension with CKD
  • Hypertension with Dyslipidemia

Pulmonary Arterial Hypertension (PAH):

  • Symptomatic PAH
  • Treatment-Naïve PAH
  • PAH with Long-Term Oxygen Use
  • Pulmonary Hypertension

What Sets Worldwide Apart in Cardiovascular Development

Institutional CV Experience Behind Every Program

Site relationships, regulatory history, KOL networks, and adjudication infrastructure that compound over decades give every Worldwide CV program a foundation that takes years to build and longer to earn.

A Delivery Model Structured for the Longest Programs in Clinical Development

Team continuity, operational methodology, national leads, and proactive site engagement are built into how Worldwide runs CV programs, so execution quality holds across years of delivery.

Specialist Access in PAH & Genetic Medicines

Advocacy partnerships, KOL engagement, siRNA-specific operational experience, and a specialist site network give Worldwide meaningful reach in two of the fastest-growing CV indications.

Meet Our Cardiovascular Experts

Marcin Ernst, MD, MBA

President, Internal Medicine Business Unit

Alessandra Vignola

Senior Vice President, Cardiovascular & Metabolic

Monika Iten, PhD

Vice President Project Management, Cardiovascular

Rafal Ziecina, MD, PhD

Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic

Casey Ustick

Therapeutic Strategy Lead, Metabolic

MarieElena Cordisco, MA, APRN, NP-C

Senior Director, Therapeutic Strategy Lead, Metabolic

Senior Cardiovascular Partnership Built for Investor-Driven Timelines

Worldwide pairs every cardiovascular program with senior scientific, medical, and operational leaders whose experience spans the full CV spectrum, with team continuity and operational methodology purpose-built for long-duration programs.

What Sponsors Need to Know

These programs often involve living or genetically modified products, tightly coordinated handling and logistics, acute safety risks, and extended long-term follow-up obligations. Sponsors may be managing collection, manufacturing, shipping, infusion, monitoring, and post-treatment surveillance in one program, which creates more operational interdependence than many other oncology trials.

Worldwide supports oncology cell therapy studies with tailored logistics planning, detailed handling procedures, and close coordination across sites, vendors, and study teams. This includes attention to chain of custody, chain of identity, chain of condition, along with operational controls needed to ensure patient-specific products move through each step as planned.

Worldwide supports sponsors with execution built around high-acuity monitoring and fast coordination if serious events occur. For cell therapy studies, that includes planning around CRS, ICANS, TLS, hospitalization workflows, and the communication needs that come with time-sensitive safety oversight.

Worldwide supports both autologous and allogeneic cell therapy programs globally across hematologic malignancies and solid tumors. This experience helps sponsors to work with teams who understand how product flow, site readiness, patient timing, and operational complexity can vary between approaches.

Yes. Long-term follow-up is a core component of cell and gene therapy development. Worldwide supports sponsors with planning and execution that account for the operational, safety, and resourcing demands that extend well beyond the initial treatment.

While this page largely focuses on oncology cell therapy, a reflection of historical trends in oncology CGT development, Worldwide also has experience with viral-vectored gene therapy, oncolytic viruses, and other genetic medicine modalities of oncology development. This is a rapidly evolving space — we understand the complexities of regulatory planning, product handling, safety oversight across modalities. Sponsors looking for broader modality detail can also explore Worldwide’s Cell and Gene Therapy expertise.

With sites across North America, Europe, Asia-Pacific, Latin America, and the Middle East and North Africa, Worldwide helps sponsors identify sites equipped for the realities of oncology cell and gene therapy studies, including handling requirements, safety protocols, and specialized operational workflows. That support helps sponsors plan around feasibility, readiness, and execution risk early in the study.