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.

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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

  • Long-term dedicated staff or blended project-based delivery models.

  • Built-in automation for dataset conversion, TLF generation, and QC validation.

  • Adherence to CDISC, 21 CFR Part 11, GDPR, and GxP requirements.

  • Biostatisticians, programmers, SAS/R engineers, and AI specialists.

  • Rapid deployment through global talent networks and secure cloud infrastructure.

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What We Offer

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    • Development and validation of SDTM/ADaM datasets, tables, listings, and figures (TLFs). 

    • Support for clinical study reports (CSR), interim analyses, ad-hoc requests, and regulatory submissions. 

    • CDISC-compliant deliverables and FDA/EMA submission readiness. 


    • Study design, sample size estimation, and statistical methodology support. 

    • Development of Statistical Analysis Plans (SAP), Mock Shell and randomization schedules. 

    • Statistical oversight of Data Monitoring Committee (DMC/DSMB) activities, interim analyses, and integrated summaries (ISS/ISE). 

    • Adaptive trial designs applied to oncology studies to enable flexible modifications during conduct 

    • Innovative designs for rare disease studies, including crossover and randomized delayed-start approaches 

    • Simulation of operating characteristics to evaluate and optimize study design strategies 

    • Trial event projection to support accurate study planning and execution timelines 

    • Power and decision boundary analyses conducted using R to guide interim and final decision-making 

    • Comparisons with virtually matched historical data to strengthen study outcomes and interpretability 

    • Expectation–maximization (EM) algorithms and Bayesian classification methods applied to blinded data for early insights into treatment effect 

    • Data mining, predictive modeling, and meta-analyses performed to inform trial outcomes and strategies 

    • Signal detection and monitoring implemented for continuous safety and efficacy assessment 

    • Exploratory analyses conducted to guide planning and design of future clinical studies 

    • Expert statistical programming support provided to deliver robust implementation of advanced methodologies for FDA interactions  


    • Implementation of AI-powered automation for dataset conversion, TLF generation, and QC processes. 

    • Predictive modeling and machine learning integration to optimize trial design, recruitment, and analysis efficiency. 

    • Development of custom tools to reduce manual workload and accelerate timelines. 

    • Design, deployment, and maintenance of secure, compliant, cloud-enabled SAS environments. 

    • Support for hybrid infrastructures integrating on-premise and cloud solutions. 

    • Ensuring 21 CFR Part 11, GxP, and GDPR compliance for validated systems. 

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.

Value for Sponsors

  • 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.

  • Trusted Expertise

    Partner with professionals experienced in oncology, rare disease, and global regulatory submissions.

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Impact That Matters

Our AI-enhanced FSP approach empowers sponsors to build agile, high-performing biometrics teams that deliver faster and smarter — without compromising compliance or quality.
From adaptive study designs to cloud-enabled SAS environments, Hill Research transforms the traditional outsourcing model into a strategic partnership.

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