Blog
Arzneimittelzulassung vs. frühe Nutzenbewertung – die Unterschiede
Häufig gibt es Diskrepanzen zwischen den Designanforderungen der Zulassungsbehörden und der Anforderungen an Studien für die Herleitung eines Zusatznutzens nach §35a SGB V. Die Eignung einer klinischen Studie als Basis für eine Arzneimittelzulassung bedeutet nicht zwangsläufig, dass diese Studie auch für die Bewertung eines Zusatznutzens geeignet ist [...]
A hitchhiker’s guide to data review in an ongoing (“live”) study – part 2: data review for interim analysis
If you are thinking of a clinical trial, you might ask yourself why and how data review for interim analysis can be a topic for a whole article. However, in a non-interventional study there are certain challenges [...]
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?
Why the value of on-site monitoring cannot be challenged by remote/ centralized monitoring
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 [...]
A hitchhiker’s guide to data review in an ongoing (“live”) study – part 1: data review for pharmacovigilance purposes
In a way, data review for pharmacovigilance purposes is the simplest and yet most demanding kind of data review, as time is a pressing matter in this context. The data are reviewed in different time frames according to the potential risks that arise from them [...]
What to consider when planning the sample size for a non-interventional study
The determination of an "adequate" sample size is an essential part of the statistical planning process. Depending on your type of non-interventional study design and your specific study objectives, there are different approaches for the planning of your sample size [...]