Despite the scientific rigor that the pharmaceutical industry has applied to generating quality data throughout the clinical trial process, data quality issues still arise—sometimes with drastic consequences.

• Nearly a quarter (24 percent) of applications to regulators require one or more resubmissions before approval.
• Over half (52 percent) of resubmissions that are eventually approved resulted from inconsistent study results, either across endpoints, sites, or studies.
• The first unsuccessful submission adds a median delay of 435 days to the approval process.*

How can Sponsors operationalize a patient-centric approach into their drug development plans? In this paper, we discuss the value of using advanced technology—specifically centralized statistical analytics—to oversee patient safety and data quality/integrity in a risk-based manner. Relying on centralized statistical analytics will help ensure the quality of eCOA/ePRO data and compliance with ICH and FDA regulations on the use of risk-based monitoring.

*. Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE,“Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012.” JAMA.2014;311(4):378–384. doi:10.1001/ jama.2013.282542