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Despite all of the buzz around adoption of digital health tools and whopping VC investments in consumer-facing digital health firms, pharma has yet to articulate a business model for co-development or integration of behavior-modifying digital therapeutics into their portfolios.
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.
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