Statistical Expertise for Clinical Development
HSM Consultancy Services, LLC provides comprehensive statistical consulting services to support pharmaceutical, biotechnology, and medical device clinical development programs.
With more than 20 years of experience and expertise across a broad range of therapeutic areas, our statisticians provide statistical support throughout the clinical development lifecycle—from study design and protocol development through statistical analysis, reporting, and regulatory submission support.
Our team has supported numerous clinical development programs associated with successful FDA submissions and approvals, providing practical, scientifically rigorous statistical expertise to help clients make informed decisions throughout the development process.
Our Services
We work closely with clinical development teams to ensure that study objectives, endpoints, estimands, analysis populations, sample size, and statistical methods are appropriately defined and aligned with the overall development strategy.
Study Design
Protocol Development
Sample Size Calculation
Randomization
CRF Review
Estimands & Statistical Methodology
Analysis & Reporting
Statistical Analysis Plans
TLF Specifications and Mock-ups
Statistical Programming
Generation of Tables, Figure and Listings
ADaM Datasets and Define-XML Development
DSMB Support
Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
Regulatory & Strategic Consulting
Statistical Review
One-on-One Statistical Advisory
Ongoing Development Program Support