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
Trial Design & Planning
Protocol development, randomization schedules, and sample size determination.
Statistical Analysis Plans (SAPs)
Comprehensive design and implementation aligned with clinical objectives.
CDISC-Compliant Programming
SDTM and ADaM dataset generation, Define.xml, and eCRT packages.
Interim & Final Analyses
Support for DMC/DSMB activities, safety summaries, and efficacy evaluations.
Medical Writing & Publications
Integrated collaboration across biostatistics and scientific communications teams.
Why Sponsors Choose Hill Research
Regulatory Precision
Our deliverables meet FDA/EMA expectations and are BIMO inspection-ready.
Unmatched Data Integrity
Independent QC, Pinnacle 21 validation, and traceability across all datasets.
Collaborative Delivery
Seamless communication among statisticians, programmers, and medical writers.
Proven Track Record
Trusted by 10+ top global pharma companies to ensure compliant, high-quality submissions.
Impact That Matters
End-to-End Expertise
One partner from protocol to FDA submission.
Reduced Review Cycles
Prevalidated datasets minimize back-and-forth with regulators.
High-Quality Insights
Statistical rigor that supports data-driven decisions and publication impact.
Frequently Asked Questions
What is project-based biostatistics?
Project-based biostatistics provides end-to-end statistical support for a specific clinical trial or regulatory submission. Hill Research assigns a dedicated cross-functional team of biostatisticians, programmers, and medical writers who deliver inspection-ready outputs from protocol design through FDA and EMA submissions.
What types of regulatory submissions does Hill Research support?
Hill Research supports NDA, BLA, IND, and supplemental submissions to both FDA and EMA. Our deliverables are BIMO inspection-ready with independent QC, Pinnacle 21 validation, and full traceability across all SDTM and ADaM datasets.
How does Hill Research ensure data quality in project-based engagements?
Every project includes independent quality control, Pinnacle 21 validation, and end-to-end dataset traceability. Our cross-functional teams maintain seamless communication among statisticians, programmers, and medical writers to ensure deliverables meet the highest scientific and regulatory standards.
Ready to Get Started?
Contact us to discuss how our solutions can accelerate your clinical development program.