This is not to say we should do as we always did. This is also not to promote unnecessarily frequent monitoring visits or a 100% source data verification (SDV). However, in times were risk-based quality management including centralized monitoring are in the regulatory focus, I feel we forget to reflect the undeniable value that on-site monitoring can give to a clinical study [...]
For successful patient engagement keep information high and live patient centricity throughout your study. How? Let’s explore some approaches by having a closer look at 4 reasons why patient centricity is not just a buzz word.
As the coordinator or manager of a clinical trial, I have one simple goal: I want my clinical trial to be successful. However, to guarantee success, I need to be able to manage my project efficiently. But what system is suitable for this?
The for mid-2017 expected final version of the ICH-GCP guideline addendum takes the subject risk management to the next level: the extent and implementation of a risk-based quality management for a clinical trial no longer remains within the judgement of the sponsor but actually becomes a legal obligation.