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.
Why Cardiovascular Diseases Demand Specialized Support
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.
Phases, Indications, and Modalities
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
Services & Capabilities
Full-Service Cardiovascular CRO Capabilities
- Outcomes Trial Delivery & CVOT
- Heart Failure Program Delivery
- CV Endpoint & Core Lab Integration
- Genetic Medicine & siRNA Programs
- PAH Specialist Access & Enrollment
- Novel-Modality Hypertension Delivery
- Hypertension Program Support
- Global CV Regulatory Coordination
Outcomes Trial Delivery & CVOT
CVOTs and long-duration outcomes trials delivered with MACE adjudication infrastructure, DMC support, and operational methodology built for years of execution.
Heart Failure Program Delivery
HFrEF, HFpEF, acute, chronic, and decompensated HF across 1,000+ global sites and 8,900+ patients enrolled across Phase I through Phase IV
CV Endpoint & Core Lab Integration
MACE adjudication, ECG, ECHO, hemodynamics, 6MWT, iCPET, KCCQ, and composite endpoints with integrated central core-lab oversight and preferred-vendor relationships
Genetic Medicine & siRNA Programs
siRNA and genetic medicine programs integrating complex administration, genetic screening and counseling, and novel-modality regulatory strategy with large-scale CV endpoints
PAH Specialist Access & Enrollment
Phase II through Phase IV PAH delivery across specialist-access site networks, advocacy partnerships, KOL engagement, and full DSMB management in a small patient population
Novel-Modality Hypertension Delivery
siRNA, dual endothelin antagonist, and device-based hypertension programs with ABPM-capable site networks, full DSMB management, and resistant-population enrollment experience
Hypertension Program Support
Essential, moderate-to-severe, severe, and non-responder hypertension programs across Phase II through Phase IV, including comorbid populations with CKD and dyslipidemia
Global CV Regulatory Coordination
CV programs spanning NA, LA, EMEA, APAC, and CIS with national leads, regional training, and regulatory continuity through sponsor acquisition and formulation changes
Why Worldwide for Cardiovascular Disease Trials
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.
Specialized Cardiovascular Leadership
Meet Our Cardiovascular Experts
Rafal Ziecina, MD, PhD
Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic
Partnership & Approach
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.
The Dedication & Discipline Behind 30 Years of CV Delivery
Cardiovascular development pushes programs further in duration, scale, and endpoint complexity, and Worldwide has delivered at every point on that spectrum for 30 years.
150+
CVM Trials
400+
Team Members
60+
PMs
Phase I through Phase IV across heart failure, CVOT, PAH, lipid disorders, siRNA, and hypertension, with 60+ PMs averaging five to fifteen years of CVM experience and 14 dedicated medical monitors
15000
Patients
180+
Sites in a Phase III
siRNA Program
Alongside Phase III LDL-C siRNA across 3,275 patients and 275 sites, and the Inclisiran Portfolio spanning 330+ sites across 19 countries
473
Sites
12000
Patients
1738
Events Adjudicated
CAMELLIA-TIMI 61 CVOT across eight countries, under 2% loss-to-follow-up under 2%, with 15,246 patients screened over a 22-month recruitment period.
Frequently Asked Questions
Your Questions Answered
We have answered the questions sponsors ask most often about cardiovascular programs. If yours isn’t here, our cardiovascular team is happy to help.
CVOT governance is built around adjudication committee infrastructure, DMC support, and a no-data-backlog approach from protocol design. Site selection is built around patient pathway and triage understanding, with national leads driving country-level start-up strategy. On CAMELLIA-TIMI 61, 1,758 events were adjudicated across 473 sites, continuous site monitoring averaged 170 visits per month, and lost-to-follow-up held under 2% across 22 months of recruitment.
Regional training, early site interaction, PAH expert utilization, and advocacy partnerships identify and convert incident patients throughout the program. This approach delivered a 128% enrollment increase and 50% sustained randomization rate improvement in the final seven months of a Phase III PAH program.
Complex routes of administration, genetic screening and counseling, PK/PD design, and novel-modality regulatory strategy are integrated alongside traditional large-scale CV endpoints. The Inclisiran Portfolio required site and patient education about a new drug class while maintaining continuity through sponsor acquisition, formulation change, and regulatory inspection support to marketing authorization.
Worldwide’s CV operating model is built around team continuity. The same senior scientific, medical, and operational leaders who win the program deliver it, staying on through database lock across programs that run for years.
Central laboratory oversight includes back-up plans for high-risk countries and local-lab allowances for urgent circumstances, with preferred-vendor relationships across core CV endpoint modalities including MACE adjudication, ECG, ECHO, hemodynamics, and CGM.
Hypertension trial design has shifted toward sustained adherence, ABPM-validated 24-hour effect, and resistant-population enrollment. Worldwide brings CV outcome trial scale at the 12,000-patient level (CAMELLIA-TIMI 61), full DSMB management capability across novel-modality CV programs (siRNA, gene therapy, and device-based), and a CV operational team covering atherosclerotic CV disease, hypertension, dyslipidemias, diabetes, obesity, and CKM syndrome.
Insights
