Technology Guidance

Technology – and its ability to support data integration and analytics – is a key enabler for efficient implementation of the TransCelerate RBM methodology. The availability of a technology solution would be foundational in allowing an organization to fully implement the RBM concept to scale.

Before jumping into a new technology, however, companies need to know how it will be used in practice. Sponsor companies must understand the technology available and how it will integrate with the roles and processes set out by their RBM plan. Once organizations understand the impact that technology will have on their operations, they will be better prepared to move forward in adoption.

According to the results of a blinded survey, TransCelerate Member Companies that have implemented RBM have introduced a broad range of technical solutions – some introducing advanced technologies, others utilizing more basic software solutions that leverage their existing systems.

What is key is that technology used for RBM is designed to support a directed, data-driven, risk-based approach that provides data from multiple sources, so that users can access the information when there is a need to adjust the related monitoring activities.

What are some values and elements ideal to RBM technology?  

What are some specific types of technology systems that a RBM methodology may integrate?

Future technology solutions would need to combine clinical trial data sources and operational systems such as clinical trial management systems, to supply the necessary data for predictive analytics.

Since RBM is evolving, successful technology solutions selected and implemented now should also be able to evolve.