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

Services & Capabilities
CVOTs and long-duration outcomes trials delivered with MACE adjudication infrastructure, DMC support, and operational methodology built for years of execution.
HFrEF, HFpEF, acute, chronic, and decompensated HF across 1,000+ global sites and 8,900+ patients enrolled across Phase I through Phase IV
MACE adjudication, ECG, ECHO, hemodynamics, 6MWT, iCPET, KCCQ, and composite endpoints with integrated central core-lab oversight and preferred-vendor relationships
siRNA and genetic medicine programs integrating complex administration, genetic screening and counseling, and novel-modality regulatory strategy with large-scale CV endpoints
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
siRNA, dual endothelin antagonist, and device-based hypertension programs with ABPM-capable site networks, full DSMB management, and resistant-population enrollment experience
Essential, moderate-to-severe, severe, and non-responder hypertension programs across Phase II through Phase IV, including comorbid populations with CKD and dyslipidemia
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
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.
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.
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

Partnership & Approach
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.
FAQ & Insights
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.
Insights
Oncology Expertise