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
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.
Sep
2021
Release Notes | MyRBQM® Portal Version 6.7
MyRBQM Portal V6.7 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
Aug
2021
Release Notes | MyRBQM® Portal Version 6.3.3
MyRBQM Portal V6.3.3 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
Jul
2021
Release Notes | MyRBQM® Portal Version 6.3.2
MyRBQM Portal V6.3.2 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
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.
Nov
2020
Best Case Studies for RBQM | Controlling the Number of Open Queries
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.