Risk-Based Monitoring

Together, we’ll proactively identify, prevent and manage risks. The result? Higher quality. Together we’ll create more efficient and effective use of resources, higher quality data and greater value from your study.

Transforming Risks Into Returns.

  • Proactive, preventive and systematic approach

  • Your team includes cross-functional experts who understand your clinical trial challenges

  • Deploy your resources strategically to yield the greatest return

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Working Smarter: Make sure your resources are directed to the areas of greatest need.

You need to design a monitoring program that delivers quality and uncovers and addresses risk proactively. Working together, we will focus on risk prevention and ensuring primary data quality. With the flexibility to scale up or down and adapt efforts as study and site risk profiles evolve, our risk-based monitoring program can result not only in savings, but in higher data quality. A focus on fit-for-purpose design helps you categorize risks and proactively address behaviors that may impact patient safety, data quality, regulatory compliance and drug approval.

Design out risk. Design in quality. And deliver faster.

We understand risk and what it can do downstream. As your partner we help you reduce the likelihood of delays, rework and threatened quality. With tools like optimized site selection through Xcellerate® Clinical Trial Optimization®, we help you identify the best performing trial sites.

Document what matters in the real world.

Regulatory compliance to keep your study on track is designed in from the start, with a focus on eliminating errors that can impact patient safety and data quality. Actions taken to address risks and establish a robust state of control across the trial are clearly documented, as well as risk prevention plans.

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