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Troubled IRB closes shop

A company that serves as an independent review board for clinical trials and was caught approving a fake medical device study will close, the Wall Street Journal linkurl:reports.;http://online.wsj.com/article/SB124042341694744375.html The company, Colorado-based linkurl:Coast IRB,;http://www.coastirb.com/ was exposed in a government sting operation last month. Based on the undercover investigation's findings, the US Food and Drug Administration (FDA) sent Coast a formal reprimand on April 14 f

Alla Katsnelson
A company that serves as an independent review board for clinical trials and was caught approving a fake medical device study will close, the Wall Street Journal linkurl:reports.;http://online.wsj.com/article/SB124042341694744375.html The company, Colorado-based linkurl:Coast IRB,;http://www.coastirb.com/ was exposed in a government sting operation last month. Based on the undercover investigation's findings, the US Food and Drug Administration (FDA) sent Coast a formal reprimand on April 14 for violating rules protecting clinical trial subjects. The FDA's action resulted in Coast freezing some of its key operations and promising to devise a plan to correct its shoddy practices by the end of the month. In a linkurl:letter;http://s.wsj.net/public/resources/documents/WSJ_Letter-Coast-employees-Board-Members_041709.pdf sent to employees and board members last week and posted today (April 22) by the WSJ, the company wrote that as a result of the FDA's letter, "several key customers have already pulled their studies from Coast IRB. Thus, it was determined that Coast IRB, LLC should...





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