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Author Archives: EvanRichardson
August 2010 FDA Guidances
Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in August 2010 (links go directly to PDF documents). Special … Continue reading
Posted in FDA, Industry News
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Five Keys to Successful Adaptive Trials
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are … Continue reading
Important Steps Forward for Early Detection and Diagnose of Alzheimer’s Disease
Image via Wikipedia This is a guest post by Erik Berglund, M.D., Ph.D. Erik is a Senior Regulatory Scientist and the Associate Managing Director of Cato Research‘s San Francisco, CA office. In a recent report by Geert De Meyer of … Continue reading
Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective
Image via Wikipedia This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. The Joint Statistical Meetings is often a good place to learn about emerging issues in the … Continue reading
Bookmarks – Collapsed or Expanded?
At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened). We’re often asked … Continue reading
