QTL

Jul 2022

Release Notes | MyRBQM® Portal Version 7.0.0

By |2022-07-11T08:43:28+00:00July 11, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 7.0.0

MyRBQM Portal V6.9.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Jun 2022

Why Standards Matter in Clinical Research

By |2022-06-20T08:59:51+00:00June 20, 2022|Blog|Comments Off on Why Standards Matter in Clinical Research

The so-called "cucumber regulation" may mean nothing to you. However, it guarantees comparable products to retailers, consumers, and processors across Europe, a standard. Standardization drives quality over time and develops global trust. Do we have standards in clinical research? Yes, but not enough, and they may not always be adhered to.

May 2022

Release Notes | MyRBQM® Portal Version 6.9.0

By |2022-05-20T08:53:17+00:00May 12, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.9.0

MyRBQM Portal V6.9.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Mar 2022

Release Notes | MyRBQM® Portal Version 6.8.2

By |2022-03-17T06:54:54+00:00March 17, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.2

MyRBQM Portal V6.8.2 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Oct 2021

Milestone | We Have Just Received our ISO 9001:2015 Certificate

By |2021-11-02T06:29:03+00:00October 26, 2021|Blog, News|Comments Off on Milestone | We Have Just Received our ISO 9001:2015 Certificate

Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.

Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2021-12-22T16:59:18+00:00September 30, 2021|Blog, Case Studies|Comments Off on Risks of IMP Management Under Standard vs. Pandemic Conditions

The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.

Jul 2021

How to Build Critical to Quality Trees for Clinical Research

By |2021-08-02T10:19:22+00:00July 29, 2021|Blog|Comments Off on How to Build Critical to Quality Trees for Clinical Research

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 |2021-12-22T17:33:44+00:00June 29, 2021|Blog|Comments Off on Adverse Event Reporting as an Example of the Risk Assessment Process

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 |2021-10-26T09:01:42+00:00May 5, 2021|Blog|Comments Off on 7 Most Important QTLs for Clinical Trials

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.

Jun 2019

A Big Thank You to All Our Poster Visitors at DIA 2019!

By |2019-07-01T17:01:11+00:00June 27, 2019|Blog|Comments Off on A Big Thank You to All Our Poster Visitors at DIA 2019!

¡Buenos DIAs! Blown away that so many folks visited our QTLs vs KRIs poster presentation! Here is the infographic in the event that you plan to do home-work.

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