Proven Statistical Leadership
Our statistical strategies are backed by decades of GI-specific experience and academic rigor:
- 30+ years of specialized GI clinical trial expertise
- Supported >70% of all IBD compounds currently in development
- 200+ peer-reviewed publications in the last 5 years
GI-Focused Statistical Design and Analysis
Great statistical design starts with endpoints that match the disease. We then appropriately size the study, select the most robust models, and set rules that fit your data collection, including visit timing, imaging with central reading, biomarkers, and follow-up.
Thorough Statistical Design Services
We apply rigorous statistical methods to ensure every aspect of your trial design is robust, compliant, and optimized for decision-making:
Sample size and power
Calculated for the questions you need to answer and tested with simulations
Advanced modeling
Longitudinal, time-to-event, generalized linear, and Bayesian when appropriate
Multiplicity and missing data
Upfront strategies to handle multiple comparisons and missing data points so your results hold up to scrutiny
Interim analyses
Clear boundaries and roles, with unblinded work strictly segregated to maintain integrity
PK/PD Modeling
For pharmacokinetics and pharmacodynamics (PK/PD), we design the sampling scheme, select the optimal model, and connect exposure to response so results can inform dosing and later trial phases.
Adaptive Trial Design
When it’s appropriate, we specify adaptations (group-sequential stopping, sample size re-estimation, enrichment, or response-adaptive randomization) and simulate their impact to validate performance before implementation.
Rigorous Statistical Design
When you partner with Alimentiv for statistical design, you’ll receive:
- Statistical analysis plan (SAP) with mock shells for key outputs
- Simulation summaries, including an assumptions log
- Interim analysis charter development and calendar
- Programmed tables, listings, and figures (TLFs) and mock outputs
Partner With the GI Statistical Design and Analysis Experts
We integrate with clinical trial design services early, maintain close communication with operations, and coordinate with data science and imaging so all analyses accurately reflect your study.
