Sep 23, 2020
How can sponsors, CROs, and sites improve the performance of clinical researchers? That’s one of the important issues discussed in SAM Sather’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Sather, Cofounder and Vice President of Clinical Pathways (CP), LLC, a consulting firm in North Carolina, leads the quality management consulting services for the company. She talks about the critical importance of human performance improvement (HPI) for the clinical trials industry, a science that is particularly significant today given the integration of quality risk management and GCP. HPI is about structuring your organization in ways that enable your employees to be star performers and engage in critical thinking, Sather says. “It’s based on doing a business analysis and defining what matters … and is very linked to metrics and what is an enforceable agreement, and [involves] the concepts of gap analysis and root cause as well.” she explains. One HPI model successfully used by Sather is Gilbert’s Behavior Engineering Model (BEM), which considers factors on two levels: environmental and individual. All factors included in these levels are equally important and need to be present for individuals to perform well. For example, organizations implementing risk-based management should consider whether it truly provides team members with the information, resources, incentives, knowledge, capacity, and motivation they need to succeed. The pandemic has pushed the industry to be agile and some stakeholders have succeeded, and others haven’t, she concludes.