Does the TransCelerate RbM Guidance Offer Standardization?

Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post

The concept of risk-based monitoring (RbM) is evolving, as nonprofit organizations continue to collaborate with the biopharmaceutical/medical device industry to investigate, pilot and implement RbM practices. While the industry seems to be getting closer towards implementing RbM programs, the subject is still at its infancy, as the industry explores this paradigm.

The biopharmaceutical/medical device industry is still trying to find ways to establish standardization in its business processes and technological infrastructures in order to seamlessly conduct RbM, however, current RbM practices lack standardization. This, in essence, defeats the core purpose of RbM, which involves generating reproducible and consistent results in monitoring and study execution quality.

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