Blog

Nov 2020

Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

By |2020-11-03T14:42:10+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Controlling the Number of Open Queries

By |2020-11-03T14:43:21+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Accurately Predicting Important Events

By |2020-11-03T14:44:18+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest

By |2020-11-03T14:45:36+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Sep 2020

FDA Concerned About Statistical Power COVID-19 Impacted Clinical Studies

By |2020-09-29T05:40:58+00:00September 10, 2020|Blog|0 Comments

Checking and maintaining trial integrity, and proactively adjusting trial analysis strategies to ensure trial data validity, are the FDA's two key areas of concern.

Aug 2020

Optimization of eCOA Data Quality using Risk-Based Quality Management

By |2020-08-17T09:26:20+00:00August 14, 2020|Blog|0 Comments

It took a pandemic to eventually shift the focus to long-overdue regulatory changes. In this article, we explore the concept of risk-based eCOA and how it has evolved over time to befit this ‘new normal’ phase.

Feb 2020

Indication Focused RBQM for Rare Disease Drug Development

By |2020-02-28T08:30:17+00:00February 28, 2020|Blog|0 Comments

Adaptive and intelligent Risk Based Quality Management (RBQM) is a powerful strategy for rare disease research. One of the main benefits is that RBQM allows for patient-centric trial design that is uniquely tailored to the specific rare disease.

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