Coast IRB Suspends Clinical Trial Enrollment Following Government Sting
This article was originally published in The Gray Sheet
Executive Summary
Device and drug companies will have to find new institutional review boards to oversee some of their clinical studies in the wake of FDA restrictions on Coast IRB, a widely-used IRB in Colorado Springs, Colo
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Coast IRB closes doors
Coast IRB, a widely-used institutional review board based in Colorado Springs, Colo., is shutting down following an undercover sting by the U.S. Government Accountability Office highlighting systemic oversight problems, although the firm previously thought it would submit a corrective action plan (1"The Gray Sheet" April 20, 2009, p. 7). Several high-profile customers reportedly pulled their business once the troubles surfaced, including biotech firm Genentech. In an April 24 letter, Coast explains that it will transition ongoing operations to Columbia, Md.-based Chesapeake IRB
Coast IRB closes doors
Coast IRB, a widely-used institutional review board based in Colorado Springs, Colo., is shutting down following an undercover sting by the U.S. Government Accountability Office highlighting systemic oversight problems, although the firm previously thought it would submit a corrective action plan (1"The Gray Sheet" April 20, 2009, p. 7). Several high-profile customers reportedly pulled their business once the troubles surfaced, including biotech firm Genentech. In an April 24 letter, Coast explains that it will transition ongoing operations to Columbia, Md.-based Chesapeake IRB
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