This week Applied Clinical Trials published an interesting case study of the risk-based quality management learning curve. The provision of a set of training modules helped Merz Pharma to initiate a smooth RBQM rollout.
Adaptive and intelligent Risk Based Quality Management (RBQM) is a powerful strategy for rare disease research. One of the main benefits is that RBQM allows for patient-centric trial design that is uniquely tailored to the specific rare disease.
The need for a controlled research environment adds another risk dimension to the Phase 1 study design. The new Healthy Volunteers - Phase 1 RACT serves as a helpful source to ensure maximum subject safety and a reliable outcome.
As change can be a significant source of risk, RBQM or risk-based monitoring (RBM) implementation programs should include a roadmap and change management plan for initiating a process of continuous improvement.
Cyntegrity proudly welcomes MERZ Pharma to its MyRBQM Academy Alumni community! Established in 2019, Cyntegrity's MyRBQM® Academy, unites comprehensive online education, instructor-led classroom training and practical case study workshops.
MyRBQM Portal V6.0.8 has released! We're constantly working to improve your Risk-Based Quality Management experience, here's a summary of what has changed.
Cyntegrity, today announced its expansion into the USA with the appointment of David Lacagnina to its senior management team.
MyRBQM Portal V6.0.6 has released! We're constantly working to improve your Risk-Based Quality Management experience, here's a summary of what has changed.
A German pharma supply chain consortium formed by esteemed industry leaders Bayer, Boehringer Ingelheim, Frankfurt University of Applied Sciences, GEFCO, and others, announces its partnership with risk-based quality management pioneer Cyntegrity Germany GmbH.
Spare yourself a fall-from-grace by so called 'data detectives'. Implement RBQM, better sooner than later, and detect problems prior to publication.