Tag Archive: clinical study report

Feb 04 2013

New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Humanitarian Use Device (HUD) Designations E3 Structure and Content of Clinical Study Reports – Questions and Answers …

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Jun 30 2011

Clinical Study Reports to STFs

Module 5 - No STF

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

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Nov 19 2010

Download the Slides from the Data Quality and Integrity Webinar

Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success!  For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for details on our upcoming webinars! Related articles: Introduction to Good Clinical Practice Webinar Slides (ask-cato.com) …

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Nov 05 2010

Data Quality and Integrity: From Clinical Monitoring to Marketing Approval

At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.”  The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist from our office in Montreal, Canada.

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