Key Risk Indicators – The Vital Few

Risk-based monitoring (RBM) has gradually evolved into holistic risk-based quality management (RBQM). The cloud has made centralized monitoring of all risk-related trial factors a seamless reality, wherein Key Risk Indicators (KRIs) play an important role.

Risk Based Quality Management (RBQM) supports study teams with making timely safe and sound decisions, and revolves around 5 questions:

  1. What might go wrong?
  2. What is the likelihood that it will go wrong?
  3. What are the consequences?
  4. How easy is it to detect?
  5. How can it be resolved?

A risk indicator can be any metric used to identify your risk exposure over time. It becomes a KRI when it tracks an important risk, or does so especially well because of its predictive value.

KRIs in clinical trials could be safety, performance or financially driven. They could contribute either marginally or substantially to the identification of a risk. Some Key Risk Indicators are more frequently being used than others.

What makes a good risk indicator?

Ideally you want the indicator to be relevant, measurable, predictive, easy to monitor, auditable, and comparable.

KRI Modules Available in Cyntegrity’s MyRBQM® Portal

Each of the KRI modules holds a set of carefully selected and validated key risk indicators, and are all 21 CFR part 11 and GCP compliant.

Each KRI is tested based on retrospective methods using real and artificial data. The KRIs are developed based on the most recent industry standards and with the support of industry experts and key opinion leaders as well as our own internal “KRI think tank”. Our KRI think tank consists out of academics with substantial field experience either as CRA, lead CRA or clinical project manager.

Let’s discuss your needs!