Ergomed was an early adopter of a risk-based quality management approach to managing clinical trials.


As clinical trials become more complex and the volume of data grows exponentially, it has become increasingly important to be proactive in the conduct of clinical trials.

As FDA director David Burrow said: “The risk-based quality management concept is the whole system, not just the last component of monitoring.”

Our risk-based quality management approach has been developed and refined to manage the rising complexity of studies. It goes far beyond simple monitoring to ensure that risks are identified, monitored, evaluated and mitigated throughout study design, conduct and evaluation.

Ergomed’s risk-based quality management approach and systems:

  • Meet all FDA and EMA regulatory requirements
  • Are based on a continuous flow of information about the investigational medicinal product(s) to improve patient protection and data reliability.
  • Ensure a swift and smooth implementation
  • Deliver lower costs, improved data quality, higher patient safety, time savings and greater compliance.
  • Offer an adaptive clinical trial monitoring strategy that includes central monitoring in combination with triggered on-site/remote monitoring and targeted source data verification.
  • Will ensure continuous adjustment to trial dynamics to keep the focus on subject safety and ensure we obtain meaningful data.
  • Use our risk assessment categorization tool (RACT) and quality tolerance limits (QTLs), which allow us to move away from 100% source data verification of patient data and employ various tools, platforms and dashboards to identify early signals.

“Due to the RBQM built-in alert mechanisms, there are no late negative surprises. There is also the ability to maintain the study within timelines, build a knowledge base for intra-study comparison, predict the success of a study, and further reduce study costs.”