As the new year of 2018 begins, it does so with the transition to Risk-Based Monitoring (RBM) one of the key initiatives on the table for the clinical trials industry.
Backed by federal regulators, RBM urges a move away from ‘rote’ approaches to quality control – for example, 100% Source Data Verification -- in favor of a variety of heads-up, algorithm-driven assessments of potential trouble spots, with preventive and corrective actions the key focus for study monitoring activities.
Veracity Logic (VL) has contributed to the RBM discussion in these hot topic pages on more than one occasion, highlighting some of the many key data points available first in IRT (IWR/IVR) systems, data that support the RBM initiative (for example: Actionable Intelligence from the IRT for CRAs or Risk-Based Monitoring with IRT)
In alliance with Algorics Inc. (http://www.algorics.com/), we continue to explore and enhance the role of IRT in the new world of RBM. The focus on RBM principles is key in the latest ICH E6 r2 issue of ICH GCPs. Click here for a detailed whitepaper from Algorics on E6 and RBM.
An ongoing key source for RBM enactment as we move into 2018 is TransCelerate BioPharma Inc., an industry non-profit whose mission is “to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.” TransCelerate offers a Risk Assessment and Categorization Tool (RACT) for the RBM initiative. Though not without controversy, the RACT remains a solid beginning for consideration of RBM issues. Click here for more information on the TransCelerate RBM model.
As the year proceeds, Veracity Logic (VL) will continue to attend these most critical transitions in clinical trials processing and the role of IRT data collection. Keep an eye on the VL website for future developments!
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