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.
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.
Spare yourself a fall-from-grace by so called 'data detectives'. Implement RBQM, better sooner than later, and detect problems prior to publication.
Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry.
¡Buenos DIAs! Blown away that so many folks visited our QTLs vs KRIs poster presentation! Here is the infographic in the event that you plan to do home-work.
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
Neat Features: wanting to dig a little deeper into the neat software features that make your risk-management life easy? Well, you’ve come to the right place. Learn more about Risk Flowers charts - a bunch of information.
Even without it being mandated, health authorities typically expect pharma and biotech companies to conduct two well-controlled Phase 3 trials demonstrating efficacy and safety. Still today this principle ensues discussions regarding the quantity and quality of the evidence needed to establish effectiveness.
To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.
