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Moving Management of Clinical Data Standards Out of the Stone Age

For the past decade, there has been more and more of a push toward clinical data standardization, and with the Prescription Drug User Fee Act (PDUFA) authorizing the FDA to mandate clinical trial..

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Forming a Clinical Metadata Management Working Group

In March of this year, an Emerging Technology working group was formed at the FDA/PhUSE Annual Computational Science Symposium. The group was launched with two main areas of focus:  metadata..

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TransCelerate BioPharma to Address Clinical Data Standards

Last year was record setting for new drug approvals, with 39 new drug and biological products approved in the U.S., the highest number in 16 years. The prediction is for even more approvals in 2013. 

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Don't Miss d-Wise at the Upcoming FDA/PhUSE Event!

d-Wise Technologies will be at this FDA/PhUSE event, (booth #6) and will be promoting Reveal, our clinical search software for clinical programmers as well as sharing some unique case studies on ..

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FDA/PhUSE 2013: A Working Group Overview

d-Wise Technologies will be participating at this year's FDA/PhUSE event in Silver Springs, MD. March 18-19.

The event will provide updates on collaborations with project groups to improve..

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Building a Hosted Statistical Computing Environment: Is it Possible?

Despite their size, small pharmaceutical companies must adhere to the same regulations that govern large ones. Production of statistical computing environments must be validated and compliant; no..

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