Europe

goBalto complies with European trial regulations

Wednesday, October 21, 2015

San Francisco-based goBalto, a provider of cloud-based clinical study startup solutions, has announced compliance with new European regulatory directives aimed at creating an environment that is favorable for conducting clinical trials across the European Union.

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European patient engagement in critical condition

Thursday, October 15, 2015

Western Europe boasts one of the largest and most active markets for clinical trials. Indeed, more than one in five active clinical investigators is based in Western Europe, and the growth in sponsor spending there now outpaces that in the U.S.

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EMA fast-tracks antidote to Pradaxa

Monday, September 28, 2015

The EMA has recommended granting a marketing authorization, following Accelerated Assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.

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