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Clinical Trial Optimization Podcast

Implementing the Successful Total Cost of Quality Model in Clinical Trials: Yes, You Can —and Must —Eliminate Waste with Linda Sullivan and Keith Dorricott


What’s the best way to get rid of unproductive waste in clinical trials? That’s one of the important issues discussed in Keith Doricottt’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Keith Dorricott, a Lean Sigma Master Black Belt with extensive experience in process improvement at CROs, is now Director at Dorricott Metrics & Process Improvement Ltd. in England. Dorricott describes the origins of the Total Cost of Quality Model in the US and its early adoption in Japan. He also discusses the basic idea that there is a balance between good and poor cost of quality – there are costs to building quality in, but much greater costs when quality does not meet the required standard. The costs of quality failure can include protocol amendments, low enrollment, extended timelines, rework, reputational damage and delay to market. Dorricott suggests- that there be greater accountability for those responsible for certain processes rather than a simple reliance on others to find issues later and then have the cost of fixing them. Dorricott says that there are now ways to estimate the costs of poor quality, and that indeed the biggest challenge for the clinical trials industry is how to become more efficient and ultimately bring more high-quality therapeutics to market sooner to impact patients’ lives.

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