Ergomed’s risk-based monitoring systems keep us at the cutting edge of innovation in clinical trials.


Risk-based monitoring is increasingly preferred and recommended by the FDA, EMA, ICH and other regulators. It ensures the optimization of monitoring efforts, as well as complete oversight and early identification of risks to patient safety or data reliability.

FDA guidelines recommend the following steps in risk-based monitoring:

  • Identify Critical Data and Processes to be Monitored
  • Risk assessment
  • Factors to Consider when Developing a Monitoring Plan
  • Monitoring plan.

Due to the built-in alert mechanisms in our advanced risk-based quality management system, there are no surprises. Risk-based monitoring is crucial in ensuring that the study is maintained within its timelines, a knowledge base is built for intra-study comparison, the success of a study is predicted, and study costs reduced.

Ergomed’s risk-based monitoring approach:

  • Allows for the detection of issues earlier, preventing any serious consequences.
  • Reduces the time spent on low-value activities, so reducing costs.
  • Ensures data quantity is reduced, by verifying data at high-risk sites and focusing on triggered events, which leads to improved data quality and reduced costs.
  • Helps to supplement or reduce the frequency and extent of on-site monitoring.

Our highly qualified monitors evaluate your protocol and develop the best approach for your specific needs, typically through one or more of the following RBM strategies:

  • Statistical monitoring
  • Centralized monitoring
  • Remote monitoring
  • Reduced monitoring
  • Triggered monitoring.

Our team works closely with you and the sites to tailor a strategy that best fits your needs and takes into account the unique nature of each site, ensuring smooth running throughout the trial.