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Aug 2017

Predictive Analytics in RBM (cont.)

By | 2017-09-18T19:55:38+00:00 August 8, 2017|Blog, Library, RBM Product Updates, Weekly RBM Feature, White Paper|0 Comments

In our previous "predictive analytics in RBM" article, we started a discussion about algorithms of machine learning (ML), predictive analytics, and artificial intelligence. We also covered that a risk software needs to calculate forecasts of Key Risk Indicators (KRIs) proactively and alerts when they [...]

Aug 2017

Predictive Analytics in RBM

By | 2017-10-04T17:01:30+00:00 August 2, 2017|Blog, Library, Weekly RBM Feature, White Paper|0 Comments

Predictive analytics is a very useful tool in the risk-based monitoring and overall risk-based study management. It increases the proportion of correct decisions, as the decisions start being more data-driven. It also helps to understand for a central CRA or study manager the trending [...]

Jan 2015

The RbM Consortium: 10 Burning Questions about Risk-Based Study Management

By | 2016-11-16T18:35:47+00:00 January 14, 2015|White Paper|2 Comments

Moe Alsumidaie, María Proupín-Pérez, PhD, Artem Andrianov, PhD, Beat Widler, PhD, Peter Schiemann, PhD, Johanna Schenk, MD, PhD Originally published on Applied Clinical Trials [link to the article]. Quality Risk Management (QRM), Quality by Design (QbD), Risk-based Monitoring (RbM), data driven monitoring or centralized monitoring [...]

Dec 2014

Duality of Risk-based Monitoring Definition: EMA vs FDA

By | 2016-11-16T18:35:47+00:00 December 9, 2014|White Paper|Comments Off on Duality of Risk-based Monitoring Definition: EMA vs FDA

In October 2014 at the Risk-based Monitoring conference in Copenhagen the Senior Director QA Operations of Janssen, Jan Van Parijs said: "Industry is historically heavily regulated, so as an industry we are kind of used to the fact that the authorities provide a set of [...]