End-to-End Statistical Expertise for Every Stage of Your Trial
From study design to NDA submission, Hill Research delivers full-service biostatistics and programming solutions that ensure accuracy, compliance, and regulatory success.
Next-Level Biostatistics Support
Hill Research provides project-based biostatistics and statistical programming services designed to accelerate your clinical development programs.
Our cross-functional teams of biostatisticians, programmers, and medical writers deliver inspection-ready outputs — from protocol design and SAP development to FDA and EMA submissions
With proven experience in NDA, BLA, and IND filings, we ensure your deliverables meet the highest scientific and regulatory standards, empowering you to move from data to decision with confidence.
What We Deliver
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Protocol development, randomization schedules, and sample size determination.
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Comprehensive design and implementation aligned with clinical objectives.
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SDTM and ADaM dataset generation, Define.xml, and eCRT packages.
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Support for DMC/DSMB activities, safety summaries, and efficacy evaluations.
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Integrated collaboration across biostatistics and scientific communications teams.
Why Sponsors Choose Hill Research
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Regulatory Precision
Our deliverables meet FDA/EMA expectations and are BIMO inspection-ready
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Unmatched Data Integrity
Independent QC, Pinnacle 21 validation, and traceability across all datasets.
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Collaborative Delivery
Seamless communication among statisticians, programmers, and medical writers.
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Proven Track Record
Trusted by 10+ top global pharma companies to ensure compliant, high-quality submissions.
Our project-based CRO model combines the depth of traditional statistical services with modern automation and AI-assisted validation.
This hybrid approach ensures faster turnaround, reduced cost, and uncompromised quality — allowing sponsors to achieve regulatory milestones with confidence and precision.
Impact That Matters
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End-to-End Expertise
One partner from protocol to FDA submission.
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Reduced Review Cycles
Prevalidated datasets minimize back-and-forth with regulators.
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High-Quality Insights
Statistical rigor that supports data-driven decisions and publication impact.