RBM in 2018

IRT Essentials

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)

Managing Drug With IRT

Case Studies, IRT Essentials

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?

Here’s a quick checklist of things to consider:

Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include: