It is an exciting time as risk-based monitoring (RBM) application grows throughout industry.
This year at CBI’s RBM Conference, Dr Maria Ali, Manager of George Clinical’s Medical and Scientific Liaison group, joined a large gathering of professionals from around the world to share ideas in applying RBM concepts.
Every organization is trying to find the right solution to implement, and there is a degree of variance in how different organizations are interpreting what RBM encompasses. TransCelerate, a not-for-profit organization made up of some of the world’s largest biopharmaceuticals, are currently running 26 projects on their RBM model, and plan to publish the results to guide industry on lessons learnt and the effectiveness of this approach. This will have great impact in direction and guidance to what RBM should include, how it should be implemented, and how to measure it’s success.
The FDA engagement at the conference was also very encouraging and supportive of the use of RBM. They discussed useful recommendations and also indicated their support for new technologies that would simplify many aspects of the clinical trial process.
Service providers should play an active role in RBM development, not merely apply components of what they assume the sponsor demands. We too have a responsibility to address what is becoming an increasingly unsustainable cost of clinical development. A robust RBM model that lays out processes and methods clearly, and in a manner that stands up to rigorous scrutiny, is fast becoming a minimum requirement.
An important evolution is on the way we manage our resources. Centralized monitoring is the role of a central monitor, or a team composed of CRAs, DM and Stats personnel. This challenge to the traditional skill set of these personnel calls for a change in the way we train, develop, manage and collaborate between these historically segregated teams.
At George Clinical, we will soon be sharing our wholistic approach to RBM, and we greatly look forward to contributing to the advancement of this model.