Central to the discussion of assuring access to safe and effective therapeutics and devices is the recruitment of study participants who represent those destined to use these products.
What must life sciences company leaders do to make sure their staff are engaged? While there are many aspects to be considered, one that takes this goal a long way is having an effective training program.
Better stress management and coping abilities have been noted in those professionals who have undergone mindfulness training. This increase in resilience can help project managers lessen the negative impacts of their demanding jobs.
Revolutions of the “way things are” vs. “the way things should be” sort are happening everywhere in the clinical research enterprise—for example, in trial designs and technologies, in workforce training and development, in regulatory compliance, in data management, and in patient recruitment and retention.
In vitro diagnostic devices are regulated as medical devices in the United States, but the obligations to demonstrate diagnostic test reliability involve some unique study designs and study implementation technicalities worth reviewing.