This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.
Discover KRI Wiki, the only Key Risk Indicator resource out there that provides a compliant by-design approach to clinical trial risk management.
MyRBQM Portal V7.0.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
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.
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.
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.
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.
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.
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.
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.
