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International Clinical Trials

Data Literacy: Modernising Clinical Trial Execution

There was a time when clinical trials followed a uniform, predefined format. That time has passed.

Today, clinical trials take on a multitude of designs basket trials, umbrella trials, and adaptive trials have increased in popularity, consequently telescoping trial timelines and cost structures, while increasing participation opportunities for patients eager for effective treatments. Decentralised trials have also gained serious traction, their perceived value now exponentially enhanced by the exigencies of the pandemic.

New trial designs are better supported when executed using a risk-based quality management (RBQM) framework that enables further safety and drives higher quality within a rapid, agile framework. Yet, effective RBQM cannot occur without trial teams that are data literate and can use data to think critically and make fact-based decisions. Its time to reskill the clinical trial industry.

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About the Author

Kristin Mauri, Director of Solution Services, Remarque Systems, has more than 25 years of clinical research experience, including eClinical technology implementation for pharma, biotech, and CRO organisations. A recognised thought leader and industry speaker, Kristin has extensively presented on the clinical operations topics of risk-based monitoring, quality management, clinical trial forecasting, and budgeting.
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