Preparation
Targeted literature reviews
Our deep understanding of clinical trials in progressive diseases enables our research team to perform targeted literature reviews for superior study design.
"We're finalizing the SAP, and we only get one shot at this readout."
We work like your in-house statistical team, with 100+ regulatory submissions behind us. We catch issues before they become deficiency letters, because we know what the FDA will ask.
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Preparation
Our deep understanding of clinical trials in progressive diseases enables our research team to perform targeted literature reviews for superior study design.
Development
Our statisticians strategically determine optimal outcomes, sample size, modeling, adaptations, corrections, inference, and overall study strategy, informed by comprehensive data insights including our proprietary integrated historical data.
Analysis
A unique integrated statistical perspective from EDC design to final reporting, ensuring data integrity and study power, plus efficient medical coding using MedDRA and WHODrug dictionaries.
We provide independent statistical second opinions, rapidly confirming prior analyses through replication and novel post-hoc exploration. This trusted independent validation empowers strategic decision-making for companies and investors.
Least expensive point to bring us in · SAP lock
Read it before it locks. Pre-specified is leverage; post-hoc isn't.
We'll tell you what the analysis supports, and what it does not.