RBQM

RBQM is laser-focused. Risk-based Quality Management (RBQM) considers each research program holistically, identifies areas of increased risk, and uses that information as the basis for a customized monitoring program. RBQM is not “reduced” monitoring, it is strategic monitoring based on technologically enabled, risk-based algorithms that focus monitoring resources on the locations and activities where they are most needed.

RBQM isn’t static. If risk levels increase at any phase or stage of a study, monitoring can quickly be intensified.

The power of RBQM lies in risk identification and strategic vigilance.

May 2018

Key Risk Indicators Reveal Blind Spots in Clinical Trials

By |2018-05-16T09:02:30+02:00May 15, 2018|Blog|Comments Off on Key Risk Indicators Reveal Blind Spots in Clinical Trials

By design, the traditional spot-checking type of audits leave a blind spot on systemic quality threats. Key Risk Indicators however, form the core of a widely applicable concept that captures all relevant risks in scope and provides project managers and QM experts targeted and objective updates on actionable issues and trends.

Feb 2018

What is the Cost of Poor Quality in Pharma?

By |2020-09-23T09:07:14+02:00February 20, 2018|Blog, Free Infographics|Comments Off on What is the Cost of Poor Quality in Pharma?

Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.

Dec 2014

Duality of Risk-based Monitoring Definition: EMA vs FDA

By |2024-11-27T16:16:15+02:00December 9, 2014|Free White Papers|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 [...]

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