Services

Biostatistics in Clinical Trials

Ensure the validity, reliability, and interpretability of clinical trial data throughout the entire clinical development lifecycle

Biostatistics is at the heart of every clinical study—driving study design, study conduct, data collection, analysis, and reporting—and our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis. Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout clinical development.

Need biostatistics expertise or resources to support your program? Let’s Talk.

We have extensive experience providing strategic statistical consulting and services from study design and protocol development to study analysis through regulatory submission and agency meeting representation. Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.

Engage our biostatisticians for the planning and biostatistical analysis of your clinical trial and regulatory submissions projects and support for your research and developing manufacturing activities. Or, partner with us to make our biostatistical team your team.

Study design
Protocol development
Strategic statistical consulting
Sample size calculations
Endpoint development
Randomization
Statistical analysis plans (SAP)
Adaptive Design clinical trial planning, simulation and implementation
Data Monitoring Committee (DMC) services

Statistical tables, data listings, and figures for clinical study reports (CSRs), interim analysis, CSRs, and post hoc/exploratory analyses
Abstract and publication writing
eCRF design and review
Statistical analyses and reports
Regulatory Submissions - Regulatory guidance, planning, and meeting representation
Integrated safety and efficacy analyses (ISS/ISE/ISM)