Managing Change While Dealing in the Complex World of Risk-based Monitoring


We met Dr. Merom Klein and Dr. Louise Yochee Klein on a trip to Israel last year and we were impressed. We asked these innovation and change-management experts on how to thrive with all of the uncertainty and the new pressures we face as Clinical Research professionals as we deal with “risk-based monitoring.” Their answer was: “Courage.” The following is an abstract of some of their thinking directed at the concerns of senior management at Target Health.


“Anyone can see how much more uncertainty and complexity we face getting new therapies approved and on the market. You wouldn’t be the first leader to listen to the latest imperatives in a project team or portfolio review meeting and say, “Yikes! You can’t be serious! How can anyone be expected to perform that much faster, better and capital-efficiently?!? Don’t you know how things are done?” Courage. That’s what it takes to break out of our indignation and to look beyond established best-practices. Courage. That is what is needed in order to learn and adapt, as regulatory, clinical, quality, pharmacovigilance, finance and other professionals may challenge our plans to introduce new technologies and up the ante. Courage. That’s what it takes to turn off the news about the latest corporate downsizing or merger and stay focused on what you can do to make a difference and built strong partnerships. Research from Israel’s Weizman Institute shows that we all have a “courage centre“ in the subgenual anterior cingulate cortex (agACC) region of our brains – which lights up when we grapple and engage with scary forces that we’d rather avoid. When we are threatened, research on the sgACC shows that we’re as hard-wired for adaptive creative innovative problem-solving as we are to fight or take flight. All we have to do is flip the switch. Our research with thousands of R&D and commercial teams shows how leaders activate the “courage centres” of smart capable teams – and enable them to face adversity, risk, uncertainty and seemingly unreasonable standards with the courage to adapt, innovate, accelerate, orchestrate and thrive. If you’d like to know more about the 5 Courage Activators that leaders switch on – and how you and the leaders in your enterprise measure up – take a look at the FREE courage assessment.”



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