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While there is no single correct way to develop process compliance controls to meet federal clinical trials billing regulations around Medicare, standardization of the entire billing process is key.
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The sponsor of a recent Phase II global study, conducted at more than 50 sites, invested in a centralized digital pathology core lab to ensure a homogenous and representative study population.
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The Food and Drug Administration approved nearly 40 new drugs in 2012, beating most recent totals, and is looking for provisions of the FDA Safety & Innovation Act (FDASIA) to further improve its operations and encourage innovation.
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Options have emerged that make DIY EDC technology more accessible to smaller organizations.
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CRO/SPONSOR : Trials in the Baltics eCLINICAL : DIY EDC Technology, Evaluation and Selection Also in this issue : Transforming Competition into Cooperation, Fellowships in Africa, Trial Planning and Execution
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