- Success begins long before the first patient is enrolled. Our Methodology and Strategic Services team, led by world-renowned experts, helps you bridge the gap between discovery and the clinic:
- Indication Prioritization: Identify the most commercially and scientifically viable indications for your MOA.
- Capital-Efficient Designs: Design adaptive protocols that maximize data utility for investors while minimizing patient exposure.
- Regulatory Roadmapping: Navigate the global regulatory landscape (FDA, EMA, MHRA) to secure Fast Track or Orphan Drug designations.
CRO Expertise for Biotechnology Innovation
Accelerate your biotech drug development research with full-service, personalized solutions from a global yet midsize CRO.
Or learn about our biotechnology expertiseYour Vision, Our Science: Partnering to Turn Discovery into Reality
In the high-stakes world of biotechnology, you aren’t just looking for a vendor; you’re looking for a partner who values your asset as much as you do. Worldwide Clinical Trials is a global, midsize CRO built for the unique demands of biotech. We combine the deep therapeutic expertise of a “Big CRO” with the agility, transparency, and senior-level attention that only a stable midsize partner can provide.
Our mission is your mission
Specializing in complex programs
Why Biotech Leaders Choose a Midsize Partner
Smaller and emerging biotech companies often find themselves underserved by massive, “one-stop-shop” CROs. At Worldwide, we offer a different experience:
- Direct Access to Experts: Your project isn’t handed off to a junior team. You get consistent, direct access to the scientists and operational leaders who designed your program.
- Agility & Responsiveness: We pivot when you need to. Our flat organizational structure allows for rapid escalation and decision-making, ensuring your timelines stay on track.
- Customized, Not Templated: We don’t believe in “off-the-shelf” solutions. Every trial is a unique strategic challenge—a game of chess that requires foresight and precision.
- A Proven Track Record: For over 30 years, we’ve helped biotechs navigate the “valley of death” from Phase I to successful regulatory submission.
Strategic Consulting & Trial Design
Early Phase & Bioanalytical Sciences
- Precision in Proof-of-Concept Our state-of-the-art Phase I unit and bioanalytical labs are optimized for the speed and rigor biotech assets require to reach their next milestone.
- Rapid “Go/No-Go” Data: FIH expertise designed to provide clear signals of safety and efficacy early.
- Custom Bioanalysis: Specialist biomarker development for complex small molecules, biologics, and novel modalities.
- PK/PD Modeling: Complex modeling to ensure a robust dose-selection foundation for Phase II.
Global Phase II-III Execution
- Agile Scaling Without the “Big CRO” Bureaucracy Scale your program globally without losing the “midsize” personal touch. We provide a global footprint staffed by experts who treat your program as a priority, not just another number.
- The “Pod” Model: A dedicated project management structure ensures continuity of knowledge—your team stays with you from kickoff to submission.
- Data Integrity for Exits: High-quality oversight ensures your data package is “due-diligence ready” for funding rounds, IPOs, or acquisitions.
- Global Footprint: Access to 60+ countries with local monitors who understand regional nuances.
Rare Disease & Orphan Indications
- Navigating the “Small N” Challenge Biotech is the engine of innovation for rare diseases. Worldwide is a recognized leader in this space, offering the specialized recruitment and regulatory strategies required for ultra-orphan populations.
- Patient-Centric Recruitment: Leveraging deep advocacy ties to find and retain patients in competitive landscapes.
- Regulatory Nuance: Expert guidance on unconventional endpoints and natural history studies.
Global Reach With Local Expertise
- Lean Teams, Global Impact Your biotech may be lean, but your reach must be global to remain competitive. We provide the infrastructure you need to operate like a top-tier pharma company.
- Localized Intelligence: Regional regulatory and operational knowledge to avoid local bottlenecks.
- KOL Access: Direct relationships with the global Key Opinion Leaders who influence your specific therapeutic niche.
- Site Sustainability: We select sites based on proven performance and historical data, not just geography.
Patient-Centric Care Strategies
- Engaging Patients as Partners In biotech trials—especially in rare disease and precision medicine—the patient experience is paramount to retention and data quality.
- Reducing Participant Burden: Decentralized trial elements, home health visits, and specialized travel support.
- Community Connection: Strong partnerships with patient advocacy groups to build trust and transparency.
- Inclusive Enrollment: Diversity and inclusion strategies that meet modern regulatory (FDA) expectations for representative data.
Global Site Alliance Collaboration
- Accelerated Access to High-Performing Sites Leverage our established relationships with leading research centers to jumpstart your timelines and secure priority at the site level.
- Site Insights: Gain early feedback on protocol feasibility and the current treatment landscape.
- Priority Enrollment: Access high-performing sites that prioritize Worldwide-managed studies due to our collaborative history.
- Streamlined Workflows: Integrated data systems that ensure timeliness and transparency for your stakeholders.
Precision & Personalized Medicines
- Infrastructure for Targeted Therapies For biotechs focused on targeted therapies, we provide the specialized diagnostic and logistical infrastructure needed for precision medicine.
- Diagnostic Integration: Coordination with reference labs for advanced companion diagnostics (CDx).
- Genomic Strategies: Data-driven enrollment strategies optimized for specific genetic biomarkers.
- Sample Logistics: Expertise in time-sensitive, complex sample management and chain of custody.
Cellular & Genetic Medicines (ATMPs)
- Mastering the Complexity of Living Therapies Navigating the complexities of Cell & Gene therapies requires a partner who understands the unique modality-specific risks and regulatory hurdles.
- End-to-End Support: Adult and pediatric experience across all phases, including Long-Term Follow-Up (LTFU).
- Chain of Identity: Rigorous processes to manage the complex logistics of autologous and allogeneic therapies.
- Specialized Safety Reporting: Deep understanding of the specific adverse event reporting required for gene therapies.
Radiopharmaceuticals
- Logistical Excellence for the Next Frontier As biotechs lead the resurgence in radiotherapy, Worldwide provides the specialized nuclear medicine logistics required for short-lived isotopes.
- Supply Chain Rigor: Precise management of time-sensitive radioactive materials across global borders.
- Standardized Imaging: Centralized imaging protocols to ensure data consistency and “readability” across all global sites.
- Specialized Site Selection: Access to facilities with the necessary licensing and infrastructure for nuclear medicine.
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We’re here to help your clinical trial succeed.
Modality & Therapeutic-Informed Approach
We have direct and relevant experience across solid and hematological cancers to apply to your trial, no matter your indication. Our teams have built their careers in clinical research, providing modality-specific support and specializing in small molecules, immunotherapies, and advanced therapies like radiopharmaceuticals and CAR T-cell therapies.
Award-Winning Project Teams
Our therapeutically aligned project teams have consistently won recognition for their performance excellence over the years. They pride themselves on upholding this legacy, delivering quality and being accessible to the sponsors they support.
Complex Program Expertise
Complex programs don’t have to mean difficult — partnering with an experienced biotech CRO can help. We support innovative trial designs, have the KOL and site relationships to support protocol development and enroll trials, provide the resources to support sample logistics in complex and innovative studies, and more. Whatever complexities your study faces, we have the solutions.
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