Are you GCP Audit and Inspection Ready?
RBQM done correctly can significantly reduce findings. Jo Burmester provides practical hints and tips to prepare your organization for an audit or inspection.
Nov 2021
Oct 2021
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
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
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
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
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
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
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.
Feb 2021
Collaborate on Rare Disease RACT
Are you an orphan expert? Do you care about rare? We invite you to collaborate with us on a rare disease-focused RACT that will help reveal and address orphan drug trial risks more efficiently.
Nov 2020
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.