Study Design
Sound trials begin with sound design. We work with clinical teams to define the estimand framework and translate trial objectives into precise statistical strategies including sample size calculations, randomisation schemes, and adaptive design specifications that meet regulatory expectations and stand up to scrutiny.
Statistical Analysis Plan
Our SAP authoring service goes beyond template completion. We build in our novel BRAKES approaches to maximise your trial resources.
Statistical Programming
We produce CDISC-compliant SDTM and ADaM datasets alongside complete TLF packages. All outputs are independently quality controlled with Define-XML documentation accompanying every deliverable.
DMC & Interim Support
We provide fully firewalled continuous analysis execution, through the BRAKES platform, for Data Monitoring Committees, with strict information barrier protocols that maintain trial integrity. Our team prepares DMC reports, supports ongoing data review and delivers the unblinded statistical summaries your independent committee needs to fulfil its oversight role.
Clinical Study Report
We author the statistical sections of your CSR to ICH E3 standards and provide integrated summaries of efficacy and safety for NDA, BLA, and MAA submissions. Where queries arise post-submission, our team provides precise responses, drawing on direct familiarity with the study data and analytical decisions made throughout the trial.
Stay blinded, decide sooner
Want to speed up your clinical trials with early decision making? Want to run 20+ automated interim analyses while eliminating operational bias?