Q&A | Minds-On Impact COVID-19 on Clinical Trials
We've created this "ask the experts" Q&A to provide clear responses to the questions that were most often asked by the forum's participants.
We've created this "ask the experts" Q&A to provide clear responses to the questions that were most often asked by the forum's participants.
Frontiers Health Ecosystem Companies Fighting Back the COVID-19 Outbreak As the COVID-19 outbreak continues, it has become even more challenging for patients to seek in- person medical care and for healthcare providers (HCP) to guarantee community health services for people who may have symptoms [...]
Cyntegrity developed a special COVID-19 RACT that guides those involved in clinical trials on specific risks which may arise as a result of COVID-19, and how they can mitigate them. This special RACT is part of the COVID-19 rapid deployment pack for ad-hoc centralized monitoring.
We can help establish near real-time centralized monitoring, enable the use of "ad-hoc crisis management" Key Risk Indicators (KRIs), and mitigate patient safety and study quality risks.
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.