Biostatistical Services

Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services, and statistical reports are customized and designed specifically to meet your project requirements.

We manage all aspects of your data—from study startup to submission and closely collaborate with Data
Management and Clinical teams to ensure that the timelines and milestones of the trial are met.

What we do

Interim Analysis 

Interim Analysis offered with unblinded statistical support and advice

PK/PD analysis

PK/PD analysis by modelling the relationship between exposure and response using non-linear
models and non-linear mixed effect modelling

ISS/ISE

Support for the integration of safety and efficacy data provided prior to the regulatory approval

sample size calculations

Protocol inputs including clinical study design, sample size calculations and consultancy advice

Statistical Analysis Plan

We provide statistical Analysis Plans and TLF shells