Risk-Based Monitoring (RBM) is now a regulatory requirement and directs sponsors’ oversight activities, in order to mitigate risks to data quality and ensure protocol compliance.
Based on experience Kinapse has identified three reasons that prevent implementation which can lead to the risk of being non-compliant. Biopharmaceutical companies stand to benefit from a worthwhile investment in RBM which has the potential to improve the way of conducting clinical trials.
Kinapse has identified critical success factors for designing and implementing an RBM program while complying with the ICH published requirements.
Download the white paper and get an overview on how to leverage the right technology solutions and tools and get the best value from your RBM program.