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International Clinical Trials

Beyond the Data-Hungry Beast

Digital information is so embedded in our everyday lives that it almost goes undetected. That may be a bit surprising, given the vast amount of data that we generate. Consider the fact that every minute of every day, over 41 million messages are exchanged through WhatsApp, 208,333 participants are in Zoom meetings, and 1,388,889 people make video or voice calls (1). The sheer volume of information that is being created, exchanged, and collected illustrates just how valuable data are in powering almost everything we do.

Nowhere is this value and growth more apparent than in clinical research. Over the past decade, the amount of clinical data used per trial has increased by 183%, while many sponsors are now using an average of five or more data sources per trial (2-3). Because drug development relies on the insights garnered from clinical trial data, this exponential increase presents a multitude of challenges in data management, which has led to trial delays.

The Evolution of CTMS

As clinical trial data have grown, so have the complexities of trial management. One of the key platforms for managing trials are CTMSs, which have more data to choose from than previously available, with more systems, including EDC, IVRS, and eCOA, now involved in research that can give early indicators of trial performance. These systems hold a wealth of metadata that are crucial in reporting on the operational progress of trials.

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Sheila Rocchio is the Chief Marketing Officer of eClinical Solutions and oversees the company’s marketing and product management functions. She enjoys hearing and telling customer stories, and building products and services that help clinicians, data scientists, and technologists do the challenging and important work of bringing new therapies to market.
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