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 2019

Your Practical Guide to Understanding Clinical KRIs

By |2019-03-20T10:55:19+00:00March 12, 2019|Free Infographics, News|0 Comments

Our key risk indicator infographic will give you a foundational understanding of KRIs, provide valuable examples of KRIs, and guide you towards getting started with your risk-based monitoring (RBM) program.

Oct 2018

Data Integration – A Valid Concern or a Convenient Excuse?

By |2020-09-23T10:10:46+00:00October 11, 2018|Blog|0 Comments

Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.

Jul 2018

DIA 2018 Global Annual Meeting: was this year’s theme the most dead-on yet?

By |2018-07-17T09:10:07+00:00July 16, 2018|Blog|0 Comments

The dramatic expansion of prescription drug deaths inspired this year's theme "driving insights to action". Insights that could be deployed through novel disruptive technologies such as Risk-based Quality Management (RBQM). Cyntegrity's Johann Proeve and Nimita Limaye were in Boston and share their observations with us.

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