FDA draft guidance and clinical trials

In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry. According to the FDA, the purpose of the guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. More specifically, […]

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A conversation about clinical trial costs, challenges and opportunities

A report by the Tufts Center for the Study of Drug Development claims it costs $2.6 billion to develop a drug over the course of more than a decade. When the Center conducted the same research in 2003, it cost an estimated $802 million to develop a drug — or the equivalent of $1.04 billion in 2013. So why the 8.5% […]

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