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International Clinical Trials

Through the Clouds

The ubiquitous nature of cloud computing offers new ways
to both collect information from disparate sources and
introduce real world evidence into studies. The industry is
reaching a point in which genomic, laboratory, imaging and
wearable sensor data can be ingested seamlessly into clinical
trial data management systems. These new sources create a
much richer dataset, but what do they mean for the field of
data management?

Managing the Benefits

At its core, cloud computing enables advanced machine
learning that can replace many of the mundane and error-
prone practices of traditional data management. For instance,
the ICH recently amended its Good Clinical Practice guidelines
to encourage companies to embrace risk-based monitoring
practices. Why? Because the ICH called out the pharmaceutical
industry’s misguided focus on the “completeness and accuracy
of every piece of data at the expense of critical aspects (e.g.,
carefully managing risks to the integrity of key outcome data).”

It comes as no surprise, then, that the FDA, EMA and
other agencies represented at the ICH are following suit
and encouraging fresh approaches.

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Mike Capone brings a unique blend of client-facing operational experience and strong technical knowledge to his role as Head of Operations at Medidata. In his capacity as Chief Operating Officer, Mike oversees delivery of all of the company’s products and services, including product management, software development, data science, professional services and marketing.
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