Quality defects remain a significant cause of health authority inspection findings. According to the EMA Good Clinical Practice Inspectors Working Group, findings related to quality-related issues such as Protocol Design, Protocol Compliance, Monitoring, and Data Management accounted for 23% of all findings in 2012, 21% in 2013, and 21% in 2014. And from 2000-2012, 32% of all NME submissions (N=302) failed initial submissions due to quality related issues and 53% of those were never approved, with the remaining 47% approved after a median delay of 14 months (Sachs et al., JAMA 2014).
The recent finalization of the ICH GCP E6(R2) Addendum provides a unique opportunity to incorporate risk assessment and quality into clinical study management and portfolio management.
We see increased use of risk management tools and techniques tied to quality to not only ensure compliance but also enhance operational effectiveness and efficiency at the study level and increase speed and accuracy of decision making at the portfolio level. How do you include quality risk management in YOUR portfolio?
Jeffrey Handen | TayganPoint Consulting Group | email@example.com | LinkedIn