Tag Archive: quality control

Jul 28 2011

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

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 predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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Aug 04 2010

GlobalSubmit Suite 2010 Beta Test

GlobalSubmit is hard at work on the next version of their software suite.  In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool.  As I’ve previously mentioned, I joined the GlobalSubmit team at DIA 2010 and was given a demonstration of …

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