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.

Oct 2021

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2021-10-19T07:04:49+00:00October 17, 2021|Blog, Free Infographics|Comments Off on Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.

Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2021-10-04T07:08:22+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 |2021-08-02T15:33:48+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.

Mar 2021

4 Ways to Optimize Vaccine Trials in Coronavirus Variants

By |2021-03-15T13:28:19+00:00March 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 |2021-10-25T13:30:39+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.

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