Blog

Mar 2021

4 Ways to Optimize Vaccine Trials in Coronavirus Variants

By |2021-12-22T17:35:37+02:00March 15, 2021|Blog, News|Comments Off on 4 Ways to Optimize Vaccine Trials in Coronavirus Variants

Learn how risk-based quality management (RBQM) helps simplify coronavirus vaccine development and helps mitigate any unnecessary burden from clinical organizations ensuring vaccines are readily available when needed.

Nov 2020

Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

By |2021-12-22T17:37:35+02:00November 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+02:00November 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+02:00November 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+02:00November 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+02:00September 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 |2024-11-25T18:19:38+02:00March 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+02:00February 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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