While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks just waiting to derail a company’s high dollar development programs. These risks include patient enrollment issues, site staffing shortages, logistical problems with drug supplies, and regulatory delays. Moreover, risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace.