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FDA is about to get more money and new technology to upgrade its drug safety systems. One new technique likely to emerge in a big way is "data mining"-automated safety signal detection. The question is: who will mind the data miners?
In the post-Vioxx era of increased scrutiny into clinical data, spiralling trial costs and a growing mistrust of drug firms' motives, the advantages of electronic diaries for use in clinical trials begin to look clearer. Their adoption has mirrored the industry's uptake of electronic data capture (EDC) systems more broadly: painfully slow until recently, but finally taking off.
Drug firms need to conduct more, bigger, and better-monitored trials. They also need to cut costs. Electronic data capture presents a possible, but far from straightforward, solution.
A little younger than some of its competitors in the electronic data capture world, etrials Inc. has nonetheless made a name for itself since its 1999 founding. Revenues are up, its list of customers is growing and the European marketing is beckoning for its integrated suite of products designed to streamline clinical trials for biotech and Pharma clients.
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