Expert Biostatistics Talent, Integrated Seamlessly into Your Team
Flexible Functional Service Provider (FSP) solutions that scale with your clinical development needs — enhanced by AI, guided by compliance, and powered by experience.
Empowering Sponsors with Flexible Resourcing
Hill Research's Functional Service Provider model offers biotech and pharmaceutical companies direct access to specialized biostatistics and programming talent — when and where it's needed. Our professionals embed within sponsor teams, operating under your systems, SOPs, and governance frameworks, ensuring seamless collaboration and inspection-ready deliverables.
Through a combination of domain expertise, modern infrastructure, and AI-enabled tools, we help sponsors overcome resource bottlenecks, maintain quality, and accelerate timelines without expanding permanent headcount.
Our Services
Dedicated & Hybrid Teams
Long-term dedicated staff or blended project-based delivery models.
AI-Enhanced Productivity
Built-in automation for dataset conversion, TLF generation, and QC validation.
Full Compliance Coverage
Adherence to CDISC, 21 CFR Part 11, GDPR, and GxP requirements.
Cross-Functional Expertise
Biostatisticians, programmers, SAS/R engineers, and AI specialists.
Global Scalability
Rapid deployment through global talent networks and secure cloud infrastructure.
What Makes Our FSP Different
AI + Human Collaboration
Unlike traditional FSP models, Hill Research integrates AI engineers alongside biostatisticians to boost speed, accuracy, and consistency.
Embedded Partnership
Our experts operate as part of your team, not external contractors — sharing accountability for outcomes.
Tailored Engagements
From single specialists to full functional teams, engagements scale with your study pipeline and workload.
Regulatory Confidence
Every deliverable meets global submission standards and inspection readiness expectations.
Impact That Matters
Scalable Efficiency
Ramp resources up or down based on project needs without delays.
Cost Control
Optimize budgets with flexible resourcing and technology-assisted workflows.
Accelerated Delivery
Reduce cycle times through automation and AI-driven validation.
What does a statistical programming FSP cover?
A statistical programming FSP places programmers inside the sponsor's environment to own the deliverables that sit between locked data and a submission: SDTM and ADaM dataset construction, tables, listings and figures written against the statistical analysis plan, define.xml with its accompanying reviewer guides, and the QC programming that independently double-checks each of them.
What distinguishes it from project outsourcing is where the work runs. Programmers work in the sponsor's validated systems, follow the sponsor's SOPs and version control, and the output is the sponsor's own rather than a vendor deliverable handed over at study close. Hill Research staffs these roles with SAS and R programmers alongside AI engineers, so the team writing the programs also maintains the automation that checks them.
When should a small biotech choose FSP over a full-service CRO?
The choice turns on whether the sponsor wants to keep control of the biometrics function or hand it over. A full-service CRO takes the whole study, study management included, and returns finished deliverables on its own systems and timelines. An FSP fills named roles inside a function the sponsor still runs.
That suits a company with a biostatistics lead but not yet a full department, a study pipeline that arrives unevenly, or a filing strategy that needs the data and the programs to stay in-house for the next submission. FSP also scales in smaller increments — a single senior statistician for one study, a programming team for a submission push — so capacity can be added without permanent headcount or a full-study contract.
What does an AI-augmented FSP change day to day?
The staffing model is unchanged; what changes is what the staff spend the day on. Hill Research embeds AI engineers alongside biostatisticians and programmers, and the team works with AI-enabled tooling for dataset conversion, TLF generation, and QC validation. Routine conversion and first-pass checking run as automation, which moves statistician time toward the parts that need judgment — analysis decisions, discrepancy review, and sign-off.
The governance path does not change with it. Every output still goes through the sponsor's own review and approval, and deliverables are produced to CDISC, 21 CFR Part 11, GDPR, and GxP requirements, so the trail an inspector follows looks the same as it would from a conventional FSP team.
Frequently Asked Questions
What is a Functional Service Provider (FSP) model for biostatistics?
An FSP model provides dedicated biostatistics and programming professionals who embed directly within your team, operating under your systems, SOPs, and governance frameworks. Unlike traditional outsourcing, FSP staff share accountability for outcomes and integrate seamlessly into your clinical development workflows.
How does Hill Research's FSP differ from traditional staffing?
Hill Research integrates AI engineers alongside biostatisticians — a unique approach that boosts speed, accuracy, and consistency compared to traditional FSP models. Our professionals use AI-enabled tools like TriClick™ for automated dataset conversion, TLF generation, and QC validation, delivering results faster without sacrificing quality.
How quickly can Hill Research scale FSP teams up or down?
Hill Research offers rapid deployment through global talent networks and secure cloud infrastructure. Engagements scale from single specialists to full functional teams based on your study pipeline and workload, allowing you to ramp resources without delays or long-term headcount commitments.
Ready to Get Started?
Contact us to discuss how our solutions can accelerate your clinical development program.