Building Risk Assessment and Mitigation into Study Startup
Risk mitigation pivotal to starting clinical trials
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 (SSU), 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 SSU.
Download our white paper "Building Risk Assessment and Mitigation into Study Startup" to learn how to identify and mitigate risks that may arise in starting clinical trials.
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