One partner, every model
Functional Solutions That Flex as Your Clinical Programs Grow
Worldwide Flex FSP delivers functional outsourcing and resourcing solutions across clinical operations, data management, biostatistics and programming, pharmacovigilance, and medical writing. Begin with a single specialist or an entire function, then scale as your pipeline moves.
You get the technical depth, therapeutic expertise, and global reach of Worldwide Clinical Trials, combined with the functional expertise, senior-level access and responsiveness that growing biopharma teams count on.
180+
Functional Delivery
Experience
Across clinical operations, biometrics, safety, and medical writing
87%
Repeat
Business
From clients who return for additional projects
96%
Customer
Satisfaction
Based on active sponsor surveys
5-25 days
Average Time
to Fill Roles
Across Clinical and Biometrics
Partnering as your functional service provider
Worldwide Flex FSP is a dedicated partner that starts by listening to you, then providing the right people, processes, and technology solutions to meet your unique needs. Whether we are delivering individual resources, a single function within a trial, or fully outsourcing a dedicated team across multiple programs, Worldwide Flex will scale our solutions to meet your needs.
Functional areas
Clinical operations
Project management at every level, site activation, CRAs and lead CRAs, and clinical trial associates.
Data management
Study build across Medidata Rave, Veeva, TrialKit, and Merative, backed by accredited Medidata Partner status.
Biostatistics and programming
Statistical programming in SAS, R, and Python with an internal standards-based toolkit for SDTM mapping.
Pharmacovigilance
Case processing and safety database builds in Veeva Vault Safety and Argus.
Medical writing
Regulatory, safety, scientific, RWE, and HEOR writing.
What Sponsors and Worldwide Flex Accomplished Together
Biometrics | Client-Managed
A global biopharma started with a single statistical programmer working on the client’s systems, then scaled across data management, biostatistics, and programming as the portfolio grew.
93+
Staff retention
20+
FTEs deployed in a single
month when demand spiked
Clinical Operations | Rapid Start-Up
A mid-size biotech needed to rescue monitoring on two Phase III studies plus long-term follow-up across 95 sites. Worldwide Flex onboarded the team in two weeks and had CRAs monitoring by the start of week three.
28
CRAs across
95
Sites
Full study-team structure stood up from a standing start.
Oversight Monitoring | Client-Managed
A US biotech added oversight of a large CRO’s monitoring across four projects in 18 countries, with the Worldwide Flex team working in the client’s systems. The engagement earned the next Phase III pivotal award.
97%
Project assignment
completion
89%
Corporate retention
100%
Team retention
since 2021
Scalable by Design
Most Worldwide Flex partnerships start with a single resource and grow alongside the program.
One sponsor’s growth story:
Year 1: Expanded from 1 to 7 FTEs
Year 2: Grew to 30+ FTEs across biostatistics and data management
Today: Supports the sponsor with 130+ FTEs across statistical programming, application development, and biometrics IT
On demand: Deployed 20+ additional FTEs in a single month to meet an unexpected surge in workload
Flexibility works both ways. Scale specialized support up for critical milestones, then right-size teams as needs change, without disrupting the broader engagement.
Worldwide Flex is part of Worldwide Clinical Trials, creating a seamless path from functional support to full-service delivery. As your program grows, you can expand with the same trusted partner, preserving continuity, knowledge, and momentum at every stage of development.
Frequently Asked Questions
Questions about functional outsourcing
We start by understanding your pipeline, team structure, and the functions you are trying to fill. Some sponsors 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 will help you figure out which approach fits. Our guide walks through the same framework.
Yes. 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. We can also adjust to a different operating model based on a sponsors desire to move away from embedded resources or outsourced functions.
Yes. Worldwide Flex team members and contractors 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 or more years in their functional areas.
Worldwide offers functional and full-service solutions along with hybrid models. If your program needs end-to-end study management, we can adjust from functional support into full service, or design a hybrid where some functions are outsourced and others are managed end to end.
Guide
Functional Service Providers in Clinical Development
A practical framework for deciding which outsourcing model fits your program, and how to structure a partnership that lasts.
