Blog

Nov 2020

Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

By |2021-12-22T17:37:35+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

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 |2021-12-22T17:41:30+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Controlling the Number of Open Queries

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 |2021-10-25T13:55:23+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Accurately Predicting Important Events

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 |2021-12-22T17:42:58+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest

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|Comments Off on FDA Concerned About Statistical Power COVID-19 Impacted Clinical Studies

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.

Mar 2020

Coronavirus | What if you can no longer visit your sites?

By |2020-05-13T14:36:45+00:00March 6, 2020|Blog|Comments Off on Coronavirus | What if you can no longer visit your sites?

We can help establish near real-time centralized monitoring, enable the use of "ad-hoc crisis management" Key Risk Indicators (KRIs), and mitigate patient safety and study quality risks.

Feb 2020

Indication Focused RBQM for Rare Disease Drug Development

By |2020-02-28T08:30:17+00:00February 28, 2020|Blog|Comments Off on Indication Focused RBQM for Rare Disease Drug Development

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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