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Building Risk Assessment and Mitigation into Study Startup

Risk management efforts in drug development have mostly emphasized post-marketing drug safety, but the clinical trials process has its own set of potential risks that can easily derail a company's costly development programs. For study startup, a problematic area of clinical trials, these risks include site selection and patient enrollment issues, budget and contracting delays, logistical problems with timely drug shipments, and regulatory hurdles. Risk-based challenges for this multi-step process are escalating as clinical trials become more global, and as market pressures to speed new therapies to market intensify.

As a result, better risk management is critical, and with the advent of purpose-built technologies, it is starting with study startup.

Download our white paper to learn how to identify and mitigate risks that may arise in starting clinical trials.