• By implementation of RBM pilot are you sure, you are looking at all relevant risks within a trial?
  • Are there other risks that could be missed?
  • Does RBM add additional risks?

If we rely too much on some sort of “formula”, there can be adverse effects on the quality and patient safety.

Technology plays a critical role in effective RBM. However, monitoring and trial management team are more important.

RBM is not a “formula” to configure and forget. It demands a structured, holistic approach. Only then, it can be used as a powerful tool to increase efficiency of clinical trial management.

Cyntegrity has rich experience in design and implementation of an Integrated Risk-Based Monitoring helping a company to go through change management and build up a full process around efficient RBM.

What is Integrated Risk Based Monitoring (IRBM)?

Integrated risk based monitoring is a process, where all participants of a clinical trial are involved: training department, audit, clinical trial operations, and management. Everybody is united into the highly efficient team.  Clinical trial is better managed, better conducted and in the long run costs are reduced.

The Cyntegrity team helps you in implementing the IRBM for your organization. It applies the best change management methods for all the participants:

  • sites
  • clinical monitors
  • study managers
  • data management
  • QA
  • top management

We are passionate to help our customers to unveil their efficiency. At the end of each trial Cyntegrity prepares a specialized report about the improvements and saved resources.

Integrated Risk-based Monitoring

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