Specialized Global Oncology CRO
Helping bring promising oncology therapies to patients faster
Built for the complexities of oncology trials, Worldwide helps sponsors start confidently, move quickly, and scale globally with specialized support from first-in-human through approval.
Why Oncology Demands Specialized Support
Built for the Realities of Oncology Drug Development
Oncology patients need new treatment options, and sponsors are working in one of the most complex areas of clinical development. Early decisions shape the speed, cost, and direction of the development program, while later stages bring added pressure around global execution, evolving standards of care, and competition. Worldwide helps sponsors navigate that complexity with oncology-specific expertise throughout the entire study team, a global footprint that scales seamlessly along with the development program, and industry-leading stability to help bring novel therapies into the clinic and propel them through to approval.
First-in-Human Demands a Different Model
Early phase oncology studies begin in patients, not healthy volunteers. Worldwide brings the operational and scientific support needed to move into the clinic and rapidly through dose escalation, optimization, expansion, and early proof of concept with confidence.
Global Reach Helps You Get to the Right Patients
Rare and biomarker-defined populations can make enrollment difficult from the start. With 70+ countries of reach, Worldwide helps sponsors expand earlier and access patients more broadly.
Oncology Expertise Across All Functions
Your team needs more than oncology experience in leadership alone. Worldwide brings deep oncology knowledge across all operational functions including startup, clinical operations, data management, biostatistics, safety, and clinical science.
Team Continuity Helps Protect Momentum
In oncology, team changes create disruption and are a major challenge for the industry. With 90%+ team retention and direct access to leadership, Worldwide helps preserve knowledge and bring urgency and speed across the development continuum.
Our mission is your mission
Specializing in complex oncology programs
Oncology Studies in
The Past Five Years
Staff Across 70+
Countries
Partnership & Approach
Built for Oncology. Committed to Your Program.
Worldwide is a specialized oncology partner that stays close to your study, adapts as your program evolves, and brings the right expertise across teams, phases, and geographies. With direct access to senior leadership, sponsors gain continuity, insight, and support from first-in-human through approval.
Why Worldwide
What Makes Worldwide the Right Fit for Your Trial?
One Oncology Partner Across Early & Late Phase Development
Worldwide supports oncology programs from proof-of-concept through approval, so you do not need to change partners as studies expand globally, grow more complex, or move into later phases.
Oncology Expertise Across the Full Team
Your Worldwide team brings oncology experience across all functions, not just at the leadership level. That includes startup, clinical operations, data management, biostatistics, safety, and clinical science, so decisions and execution stay grounded in the realities of oncology trials.
Continuity That Builds Trust & Reduces Disruption
In oncology, team stability matters. Consistent teams help you maintain momentum, avoid unnecessary handoffs, and establish a partnership with people who understand the drug and program as it evolves. That continuity supports speed, trust, and smoother execution across the life of the study.
Retention
Clinical Insight That Goes Beyond Reporting
Worldwide’s clinical analytics platform and clinical science team do more than collect and report data. By providing real-time visibility into study performance and patient insights throughout the trial lifecycle, we enhance oversight, surface trends, and accelerate decisions.
Focused Expertise, Not a Generic CRO Model
Worldwide takes a specialized approach to oncology rather than applying a broad, one-size-fits-all model. You benefit from a partner designed around the specific scientific, operational, and strategic demands of oncology trials.
Focused on the Needs of Biotech Sponsors
Worldwide is designed to support the realities biotech sponsors face — including urgent timelines, lean internal resources, and high-stakes development pressure. You benefit from a team aligned with how your programs actually move forward.
Services & Capabilities
Comprehensive Oncology CRO Services
- Protocol Design and Clinical Development Planning
- Regulatory Consulting and Global Submissions
- Global Project Management
- Feasibility Analysis and Site Selection Strategy
- Site Initiation and Study Start-up
- Patient Enrollment
- Dose Escalation, Optimization and Cohort Management
- Site Monitoring and Management
- Data Management
- Clinical Data Analytics and Review
- Clinical Science
- Biostatistics
- Medical Monitoring
- Safety / Pharmacovigilance
- Medical Writing
Early to Late Phase Development
Support from first-in-human, dose escalation, optimization and expansion cohorts through late-phase and registration-directed oncology development.
Global Expansion Capabilities
Global startup, regulatory, site strategy, and operational support that help sponsors expand earlier, reach the right patients, and maintain momentum across regions.
Established and Emerging Modalities
Experience supporting a range of oncology modalities, including targeted therapies, immuno-oncology (IO), antibody-drug conjugates (ADCs), and cell and gene therapy (CAGT) programs.
Operational Complexity
Support for the operational realities of oncology trials, including biomarker-driven enrollment, cohort management, safety oversight, data review, and cross-functional study execution.
Phases, Indications and Modalities
Specialized Oncology CRO Across Phases, Indications, & Modalities
Phase of Development
Cancer Indication
Worldwide’s Top Oncology Indications
- Solid Tumors
- Bladder
- Breast
- Head & Neck
- Lung
- Melanoma
- Ovarian
- Pancreatic
- Hematologic Malignancies
- Rare Oncology
Drug Modality
Worldwide’s Top Drug Modalities
- Immuno-Oncology (IO)
- Cell & Gene Therapy (CGT)
- Antibody-Drug Conjugates (ADCs)
Specialized Oncology Leadership
Meet Our Cancer Drug Development Experts
Panteli Theocharous, PhD, FRCPath
Chief Therapeutics & Clinical Strategy Officer and President of Europe
What Our Clients Say
“Having worked with Worldwide across numerous oncology studies – in both hematologic and solid tumor indications – I keep coming back to them out of appreciation for their unparalleled expertise, knowledge, organization, commitment, and highly managed oversight that their business development, project management, monitoring, regulatory, safety, data management and biostatistical teams provide.”
Executive Vice President of Development and Chief Medical Officer | Small ADC-focused Biotech
Frequently Asked Questions
Your Questions Answered
Worldwide supports oncology programs from first-in-human and escalation/optimization/expansion trials through late phase and registrational development. Our teams are built to help sponsors start fast in early phase oncology, then scale across phases and geographies as the program grows.
Worldwide is best aligned to biotech and small to midsized pharma companies. These teams are often balancing urgent timelines, lean internal resources, and high-stakes development decisions, so they need a partner that can bring urgency, flexibility, oncology expertise and practical execution support.
We help sponsors translate scientific goals into operationally workable plans. That includes support for challenges such as dose escalation/optimization, expansion cohorts, biomarker-driven enrollment, complex safety oversight, and trial designs that need to reflect real-world site capacity and patient pathways.
Worldwide helps reduce risk by bringing oncology-specific thinking to the points where studies most often slow down or fail. That includes stronger early planning, thoughtful site strategy, operational models organized around oncology complexity, database design and data review methodologies crafted with the end in mind, and team continuity that helps reduce rework, delays, and sponsor burden over the life of the program.
Oncology trials are especially complex because even the earliest phase studies are conducted in patients, not healthy volunteers. Enrollment is also more difficult because the eligible patient pool is limited, and recent shifts in oncology development have made it more important for many sponsors to go global earlier in order to reach the right patients and maintain momentum.
Worldwide’s oncology model is built around continuity from early phase development through broader global execution. Sponsors can start with a team that understands the realities and goals of proof-of-concept studies and continue with a partner that has the global reach, infrastructure, and oncology depth to support expansion without unnecessary disruption.
Worldwide’s approach goes far beyond collecting trial data. Our advanced clinical analytics and clinical science model blend visual tools with endpoint fluency that helps sponsors interpret emerging safety and efficacy signals more clearly, so they can make better-informed decisions earlier and with more confidence.
