Applied Clinical Trials-02-01-2013

Applied Clinical Trials

Regulatory Landscape Changes in Russia

February 01, 2013

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Russian regulators have reportedly implemented the much awaited changes to the nation's regulatory process for medical devices, and the revised regulations took effect at the start of January.

Medicare and the NCD

February 01, 2013

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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.

Central Lab Review Prevent Underpowered Studies

February 01, 2013

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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.

FDA Speeds More Breakthrough Drugs to Market

February 01, 2013

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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.

Applied Clinical Trials Digital Edition - February 2013

February 01, 2013

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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