Functional Solutions That Flex as Your Clinical Programs Grow
Worldwide Flex delivers specialized functional outsourcing with the technical depth, therapeutic expertise, and global reach of Worldwide Clinical Trials, plus the flexibility and senior attention most large CROs can’t offer.
Whether you need individual resources, a dedicated functional team, or hybrid support across multiple studies, we build the engagement around your program, not the other way around:
- Flexible engagement models that scale with your portfolio
- Functional experts with real therapeutic area experience
- We integrate with your existing processes, or you use ours
- Senior leadership stays engaged from kickoff to closeout
Let’s talk about your functional outsourcing needs
We listen first, then design a solution that scales with your program
Functional Expertise Across Every Phase of Development
FSP solutions built around your operational needs, phase by phase.
FSP Experience That Delivers Results
Performance metrics from our active Flex engagements.
Project Retention
No active project has been terminated by a sponsor
Repeat Business
From clients who return for additional projects
Customer Satisfaction
Based on active sponsor surveys
Average Time to Contract & Execution
Clinical: 5 days to contract. Biometrics: 25 days to contract.
Functional Solutions Across Your Development Lifecycle
From individual resources to full functional outsourcing, we scale support to fit your model.
Clinical Operations
- Project management
- Clinical monitoring
- Site management
- Study startup
- Patient recruitment planning
- Vendor oversight
Biometrics
- Data management
- Biostatistics
- Statistical programming
- Clinical data analytics
- eClinical systems
- Data quality oversight
Safety & Medical Writing
- Pharmacovigilance
- Safety management
- Medical review
- Regulatory writing
- Medical information
- Aggregate reporting
Questions About Functional Outsourcing?
How we address the common considerations when sponsors evaluate flexible engagement models.
We start by understanding your pipeline, team structure, and the functions you’re trying to fill. Some sponsors need to augment internal teams with specialized expertise. Others want full functional outsourcing for specific studies, or across the portfolio. Many use hybrid models that combine functional and full-service support. We’ll help you figure out which approach actually fits, whether that’s FSP, full service, or something in between.
Yes. Worldwide Flex resources follow the same quality standards, SOPs, and regulatory oversight as our full-service programs. Our functional specialists are the same experts who lead full-service studies, many with 15+ years in their functional areas. You get the same Worldwide quality, delivered through a more flexible engagement model.
Yes. Flexibility is the point of our Flex model. You can start with one function and add others as your portfolio grows, add resources when programs scale up, or adjust capacity between studies. Many clients begin with functional support on a single trial and expand once they see the fit.
Worldwide offers both functional and full-service solutions, plus hybrid models. If your program needs end-to-end study management, we can transition from functional support to full-service or design a hybrid where some functions are outsourced and others are managed end-to-end. The model fits the program, not the other way around.
What Sponsors Say About Worldwide Flex
Sponsors We Partner With
Different development strategies need different engagement models. Here’s how we match.
Emerging Biotech Building Clinical Capabilities
You have one or two assets in clinical development with limited internal infrastructure. You need specialized functional expertise but aren’t ready to hire full-time teams.
Worldwide Flex provides targeted functional support across clinical monitoring, data management, biostatistics, and safety; all the areas emerging biotechs typically need to fill without building permanent teams. Start with what you need most, expand as your portfolio grows, and transition to full service when your programs require end-to-end management.
Mid-Sized Companies with Established Pipelines
You manage multiple concurrent programs with strong internal leadership but need to augment capacity in specific functional areas or therapeutic specialties where you lack depth.
Our functional experts integrate with your existing teams in areas like oncology monitoring, rare disease biostatistics, and global pharmacovigilance, without forcing you to build permanent infrastructure in every specialty. Many clients use Worldwide Flex for specialized functions while managing other work internally or through full-service partnerships.
Companies Exploring New Therapeutic Areas
You’re expanding into cell & gene therapy, rare disease, or other specialty areas where your current capabilities need to be augmented with deep therapeutic and functional expertise.
Our therapeutic area specialists have led dozens of programs in the space you’re entering. We provide functional support that gets the trial executed now while transferring knowledge to your team for the future. As your internal capabilities grow, the engagement model flexes with you: a different functional mix, full service, or hybrid.
Meet Your Worldwide Flex Leadership Team
Functional experts who run the engagement personally, not from a distance.
Craig McIlloney
Senior Vice President, Worldwide Flex
20+ years leading functional outsourcing programs for biotech and pharmaceutical sponsors. Designs engagement models that range from individual resource placements to enterprise-wide functional partnerships, across all therapeutic areas and development phases.
Candace Moran
Vice President, Flex Solutions
15+ years building functional service models for sponsors with complex portfolio needs. Specializes in hybrid engagement strategies that combine functional and full-service capabilities to improve operational efficiency and study performance.
Svetlana Kolchinsky
Vice President, Flex Operations
18+ years leading clinical operations and functional teams across complex global programs. Provides operational leadership on functional engagements, integrating with sponsor processes and holding the line on Worldwide quality standards.
Searching for the right CRO partner to help with your clinical development needs?
At Worldwide Clinical Trials, we deliver high-quality, reliable, and timely clinical trial services to help optimize the success of your projects. For the second year in a row, data from the Industry Standard Research (ISR) report showed that Worldwide Clinical Trials was the highest-rated Phase II/III CRO across several categories.
Find the Right Functional Model for Your Development Programs
Every sponsor’s operational setup is different. Whether you need specialized functional support for a single study, flexible resources across multiple programs, or a hybrid model that combines functional and full-service capabilities, we’ll build an approach that fits your development strategy.
We start with your actual challenges, then design a solution (FSP, full service, or hybrid) that closes your functional gaps within your budget, timeline, and internal capabilities.
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Response within 1 business day
We respect your timeline -
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Consultative approach
We assess your needs and recommend what works best -
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Expert functional leaders
Speak with actual operational experts, not sales teams -
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Therapeutic area alignment
Matched to your development focus -
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No obligation
Explore options without pressure -
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Flexible engagement models
From individual resources to full functional outsourcing
“What impressed us most was Worldwide’s willingness to design a truly custom solution. They combined Flex support for certain functions with full-service management for others, based on what genuinely made sense for our programs, not what was easiest for them to deliver.”
— VP Clinical Development, Multi-Asset Biotech