Services

Biostatistics

Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout the entire clinical development process. 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 Statistical Experience

We have extensive experience providing biostatistical 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 to support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects. Or, partner with us to make our biostatistical team your team.

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Study design
Protocol development
Strategic statistical consulting
Sample size calculations
Endpoint development
Randomization schemes
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)