Aktuell laufen ca. 1.500 klinische Studien in verschiedenen EU Mitgliedsstaaten, deren Sponsoren ihren Sitz in UK haben. Schätzungen zu Folge werden 50 % dieser Studien auch nach dem Austritt Großbritanniens aus der Europäischen Union (BREXIT) am 30. März 2019 weiterlaufen. In diesem Zusammenhang stellt sich unweigerlich die Frage: Wie geht es mit den klinischen Prüfungen und der Zusammenarbeit mit UK nach dem Brexit weiter?
The end of the eCRF in local language? Workflows for meeting local and global demands in your non-interventional study (NIS)
What aspects do you need to consider when planning a multi-lingual eCRF? Are regulatory requirements effective 22 November 2017 a cut-off date for the future of eCRFs in local language?
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.