Tag Archives: adverse events

Imaginary patients, Imaginary data, et Cetero, et Cetero…

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

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet … Continue reading →

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Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

Posted on 10 June 2011 by Evan Richardson

UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading →

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Conference Recap – 2011 ACRP Global Conference and Exhibition

Posted on 26 May 2011 by Ask-Cato.com Contributor

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals. Continue reading →

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FDA Enforcement of New IND and BA/BE Safety Reporting Requirements

Posted on 18 May 2011 by Ask-Cato.com Contributor

FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011.  FDA’s intent … Continue reading →

Posted in Clinical Trials, FDA, Industry News | Tagged , , , , , , , , | 1 Comment

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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