Our biostatisticians apply scientific knowledge to support you. Biostatistics is at the heart of every clinical study.
They work closely with the entire project team throughout the study. For example, they ensure that the correct data is captured and ready for analysis.
We have extensive experience providing biostatistical consulting and services. For example, our biostatistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.
We support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects.
We are happy to provide the help you need at any or all of the following steps in earning the data-based answers you request:
Strategic statistical consulting
Sample size calculations
Statistical analysis plans (SAP)
Adaptive Design clinical trial planning, simulation, and implementation
Statistical tables, data listings, and figures for clinical study reports (CSRs)
eCRF design and review
Statistical analyses and reports
Pharmacokinetic and pharmacodynamic analyses
Regulatory Submissions – Regulatory guidance, planning, and meeting representation
Integrated safety and efficacy analyses (ISS/ISE/ISM)
Data Monitoring Committee (DMC) services
SDTM and ADaM dataset preparation (submission-ready dataset packages)