HSM Consultancy Services, LLC

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.

What We Do

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 & Planning

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, Figures 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

Our Technology

TFL Development Tool

A Validated, Flexible, and Efficient Solution for Clinical Trial Reporting

HSM Consultancy Services has developed a customizable and validated SAS macro platform that provides a powerful and flexible solution for generating industry-standard Tables, Figures, and Listings (TFLs), including patient profile reports.

Our TFL Development Tool is designed to support efficient, consistent, and high-quality TFL production across clinical development programs and therapeutic areas.

Key Features

Fully Validated SAS Macros

Our SAS macros are thoroughly validated and well documented to support reliable and consistent production of clinical trial outputs.

Flexible TFL Generation

The platform can generate a wide range of industry-standard TFLs, including patient profiles, and can be customized to meet individual study requirements.

Individual and Combined Reports

Generate individual and combined reports efficiently using a standardized production framework.

Automated Report Generation

The tool provides automated Table of Contents with page numbers, page breaks, and column breaks.

Efficient Use of Resources

The TFL Development Tool has been used in multiple environments and has demonstrated the ability to significantly reduce (up to 40%) the resources and man-hours typically required to generate TFLs for individual clinical studies.

Get in Touch

Contact

Email: [email address] ↗