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"We're finalizing the SAP, and we only get one shot at this readout."

In-house statistical judgment, without the headcount

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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Clinical study plan & trial design

Three stages, one continuous statistical view

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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.

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Development

Optimal outcomes and sample size

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.

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Analysis

Integrated across the lifecycle

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.

Statistical second opinion

Independent validation for high-stakes decisions

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.

  • Replication of primary and key secondary analyses
  • Post-hoc exploration to test alternative explanations
  • Plain-language readout for boards and investors
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Least expensive point to bring us in · SAP lock

Read it before it locks. Pre-specified is leverage; post-hoc isn't.

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Get a straight answer about your data

We'll tell you what the analysis supports, and what it does not.