Thursday, April 23, 2009

Coast IRB Closes Doors After Federal Investigation

From FierceBiotech:

At the beginning of this month, Coast IRB was a flourishing independent-review firm overseeing some 300 clinical trials. Today, it's dead.

The company has sent out an e-mail saying that the company's owners have decided to cease doing business. Oversight of the clinical trials it has been working with is being transferred to other independent review board companies.

Coast IRB's trouble hit hard and fast after the company approved a clinical trial for a product that never existed. Federal investigators wanted to see how much due diligence the review boards were bringing to the table. And in Coast IRB's case, that wasn't a lot--at least not in this instance.

The company CEO tried to fight back, saying that the federal sting operation amounted to nothing more than entrapment. But lawmakers were a little less than happy to hear that.

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