Tag Archives: biostatistics

Statistical Reviews of Case Report Forms

Posted on 28 April 2011 by Ask-Cato.com Contributor

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. … Continue reading →

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Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

Posted on 16 August 2010 by Ask-Cato.com Contributor

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a … Continue reading →

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When Should You Write your Statistical Analysis Plans?

Posted on 24 May 2010 by Ask-Cato.com Contributor

Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading →

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