Our expert team reviewed the March 2019 RBM Q&A guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
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.
The Clinical Trial Risk and Performance Management Summit is interactive. You’ll roll up your sleeves with speakers and fellow attendees as you tackle case studies that will bring clarity to the metrics process — and provide you with the answers you need. Don't miss (Day 1): [...]
In October 2014 at the Risk-based Monitoring conference in Copenhagen the Senior Director QA Operations of Janssen, Jan Van Parijs said: "Industry is historically heavily regulated, so as an industry we are kind of used to the fact that the authorities provide a set [...]