Jul 2021

How to Build Critical to Quality Trees for Clinical Research

By |2021-08-02T10:19:22+00:00July 29, 2021|Blog|0 Comments

Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.

Jun 2021

Adverse Event Reporting as an Example of the Risk Assessment Process

By |2021-08-02T15:33:48+00:00June 29, 2021|Blog|0 Comments

Do you find the prospect of Risk Analysis and Risk-Based Quality Management (RBQM) to be daunting? Then bear with us. We shall help you simplify and demystify the process by using an example to illustrate the key steps to consider.

May 2021

7 Most Important QTLs for Clinical Trials

By |2021-06-29T11:24:22+00:00May 5, 2021|Blog|0 Comments

Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.

Mar 2021

4 Ways to Optimize Vaccine Trials in Coronavirus Variants

By |2021-03-15T13:28:19+00:00March 15, 2021|Blog, News|0 Comments

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 |2021-03-16T14:12:24+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.

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