Classical Hematology CRO Services
Global Classical Hematology Programs Built Around Disease Prevalence and Targeted Patient Access
Worldwide delivers classical hematology programs globally with the regional infrastructure that supports delivery excellence. By leveraging nearly 500 bleeding disorder centers, established treatment-center relationships and partnerships with more than ten patient advocacy groups, we help sponsors reach patients where they live and retain them across long programs.
Why Classical Hematology Demands Specialized Support
Deep Experience in Rare and Complex Classical Hematology Tailored to Your Needs
We bring together established relationships with hematology treatment centers, deep expertise in hemoglobinopathies and immune-mediated disorders, and a delivery model built for small populations and novel endpoints, to help our partners de-risk rare hematology development and accelerate decisions.
Access to Rare Patient Populations
Established relationships with hematology treatment centers, a network of nearly 500 bleeding disorder centers and partnerships with more than ten advocacy groups, giving our partners enrollment and retention confidence in populations that are otherwise difficult to reach.
Confident delivery of Complex, High-Risk Programs
Cohort-structured early-phase programs leverage rapid data generation and review processes, providing DMC-ready data within days. Seamless operational management of cohort transitions enables continuous study progression and helps accelerate development timelines
Confident Delivery of Complex, High-Risk Programs
Worldwide brings deep therapeutic expertise, operational agility, and disciplined program execution to the delivery of complex, high-risk clinical development programs. Our teams are experienced in managing first-in-human, complex dose-escalation, advanced and novel therapies, and critically ill patient studies where rapid decision-making and flawless execution are essential
Specialized Classical Hematology CRO
From First-in-Human to Phase IV, Across Rare Hematology Indications and Modalities
- Sickle Cell Disease
- Von Willebrand Disease
- Hemophilia A & B
- Acquired Hemophilia A
- Beta Thalassemia
- Factor X Deficiency
- Erythropoietic Protoporphyria
- Immune Thrombocytopenia (ITP)
- Chronic Neutropenia
- Rare Bleeding Disorders
Services & Capabilities
Comprehensive Classical Hematology CRO Services
- Global High-Prevalence Site Activation
- Culturally Sensitive Patient Mobility
- Accelerated Cohort-Structured Data Delivery
- Operational Precision Designed for DMC Windows
- Mid-Program CRO Transition Support
- Rare Bleeding Disorder Programs
- Sickle Cell and Pediatric Program Delivery
Global High-Prevalence Site Activation
Worldwide bring established relationships with hematology treatment centers across Africa, MENA, LATAM, India, South Asia, and beyond, with enrollment strategies aligned to documented disease prevalence.
Culturally Sensitive Patient Mobility
Travel requirements, gender norms and referral pathways are built into operational planning from the start, alongside insights from our partnerships with over ten patient advocacy groups.
Cohort-Structured Early Phase Delivery
Worldwide manages cohort-structured early phase classical hematology programs with the operational infrastructure to move from one cohort to the next without losing program momentum.
Accelerated Cohort-Structured Data Delivery
Cohort-structured programs to leverage rapid data generation and review processes, providing DMC-ready data within days. Seamless operational management of cohort transitions enables continuous study progression and helps accelerate development timelines.
Operational Precision Designed for DMC Windows
Cohort-structured programs move at the pace of the DMC calendar. Our operational model is built to have review-ready data waiting when the committee meets, so the next cohort opens on the decision
Rare Bleeding Disorder Programs
Programs across von Willebrand disease, hemophilia A and B, factor X deficiency and rare bleeding indications, with partnerships in this market that have carried products through to commercialization.
Sickle Cell and Pediatric Program Delivery
Transcranial Doppler flow-velocity eligibility, formulation palatability, and the screen-failure drivers specific to pediatric sickle cell programs, worked through before the protocol is final.
Why Worldwide for Classical Hematology Trials
The Classical Hematology Outcomes That Set Worldwide Apart
Global Reach Aligned to Disease Prevalence
Site networks built around documented disease prevalence and established regional relationships, spanning 25 countries and five continents, with enrollment strategies designed for each indication’s patient population.
Operational Precision Designed for DMC Review Windows
Cohort-structured programs move at the pace of the DMC calendar. Our operational model is built to have review-ready data waiting when the committee meets, so the next cohort opens on the decision.
Mid-Program Transitions That Protect the Master Protocol
Worldwide’s transition model is built to keep programs moving, with custom processes at study, country, and site level that allow new phases to run in parallel with an incumbent CRO’s existing work.
Specialized Classical Hematology Leadership
Meet Our Classical Hematology Experts
Our hematology team includes board-certified adult and pediatric hematologists who practise in the indications they deliver, and who hold membership in the American Society of Hematology, the World Federation of Hemophilia, and EAHAD. Worldwide is a member of the Sickle Cell Disease Coalition and the ASH Research Collaborative.
Partnership & Approach
Senior Classical Hematology Partnership, Structured Around Your Program
Worldwide maintains project leadership continuity across the life of your hematology program through stable core team assignments, dedicated hematology experts, formal succession planning, and robust knowledge-management processes. Supported by consistent executive oversight and cross-functional governance.
Classical Hematology Programs Delivered Across 25 Countries and Five Continents
Worldwide’s experience spans fourteen classical hematology programs over the past five years, spanning sickle cell disease, von Willebrand disease, hemophilia, factor X deficiency and rare bleeding indications from Phase I through Phase IV.
Cohort 2 Enrollment Target Met Within Two Weeks of the First DMC Meeting
Achieved on a Phase Ib VWD program following seamless mid-program transition from an incumbent CRO, with cohort 1 enrolling six patients against a minimum target of three
Cohort 2 Enrollment Target Met Within Two Weeks of the First DMC Meeting
Achieved on a Phase Ib VWD program following seamless mid-program transition from an incumbent CRO, with cohort 1 enrolling six patients against a minimum target of three
Cohort 2 Enrollment Target Met Within Two Weeks of the First DMC Meeting
Achieved on a Phase Ib VWD program following seamless mid-program transition from an incumbent CRO, with cohort 1 enrolling six patients against a minimum target of three
Frequently Asked Questions
Your Questions Answered
We have answered the questions sponsors ask most often about classical hematology programs. If yours isn’t here, our classical hematology team is happy to help.
Worldwide delivers programs across sickle cell disease, von Willebrand disease, hemophilia A and B, acquired hemophilia A, beta thalassemia, factor X deficiency, erythropoietic protoporphyria, immune thrombocytopenia, chronic neutropenia and rare bleeding disorders, from early Phase I through Phase IV.
Site activation is built around documented disease prevalence in Africa, MENA, LATAM, India, South Asia and other high-prevalence regions, through a network of nearly 500 bleeding disorder centers. Patient mobility coordination, including travel requirements, gender norms and referral pathways, is planned from the start, and partnerships with more than ten advocacy groups help reach patients who are not already in the referral system.
Worldwide uses custom transition processes at the study, country, and site level that protect the master protocol and allow new phases to run in parallel with an incumbent CRO’s existing work. On a Phase 1b VWD program, Worldwide ran a multi-dose phase and OLE in parallel with the incumbent’s single-dose phase without rebuilding the master protocol.
Cohort transitions are managed at the operational level, not the protocol level, with rapid data turnaround built into the program plan. On the Phase Ib VWD program, DMC review-ready data was available within 10 days of the last cohort 1 subject reaching day 36, and the first two cohort 2 subjects were dosed within 24 to 48 hours of the DMC meeting decision.
Worldwide maintains leadership continuity on long-horizon hematology programs through stable core team assignments (CRA turnover runs at 9.5% against an industry average closer to 25%), dedicated hematology experts, formal succession planning, and robust knowledge-management processes. Supported by consistent executive oversight and cross-functional governance, this model preserves institutional knowledge, minimizes disruption, and ensures strategic and operational continuity throughout the program lifecycle.
Sickle cell is our largest classical hematology block, with seven programs across Phase II to Phase IV. That work has given us a settled view of the operational detail: transcranial Doppler flow-velocity ranges in the eligibility criteria, formulation palatability and dosing instructions in pediatric cohorts, and the screen-failure drivers that show up most often, from prior vaso-occlusive crisis to out-of-range hemoglobin. Worldwide is a member of the Sickle Cell Disease Coalition and the ASH Research Collaborative.
Insights
