Risk-Based Quality Management By Remarque Systems

Between 2000 and 2012, the U.S. Food and Drug Administration (FDA) cycle review failures and 16% of overall study failures were due to quality issues. As clinical trial complexity increases over time, quality issues end up taking longer to alleviate and incur greater costs. These growing risks can negatively affect a study’s operational success, make it more challenging to recruit patients, and reduce the ability to generate reliable results.