Blog
Acting out? Points to consider when planning to involve actigraphy measurements into your study design
From a medical perspective, addressing concepts of physical activity and activity capacity, vital signs (like heart rate or blood pressure), and/or sleep quality in a real-time manner rather than a snap-shot at a visit, make perfect sense and could enrich the value story of novel therapies. However, when planning to involve actigraphy measurements into your study design, there are several points to be considered, including issues of validity, data transfer and data analysis [...]
Don’t panic: It’s only the Simpson’s Paradox
Your results on the overall patient level contradict results on the subgroup level? There is no need to panic. With a deeper look into the data, one can get to the bottom of this observation. [...]
Das Bewertungsverfahren für Medizinprodukte: erste Erkenntnisse und Empfehlungen
Für welche Medizinprodukte ist die Bewertung relevant, wie läuft das Bewertungsverfahren ab und welche Lehren kann man aus den bisherigen Verfahren ziehen? [...]
Verpflichtung zur klinischen Nachbeobachtung (PMCF) von Medizinprodukten
Die klinische Bewertung ist fortan während des gesamten Lebenszyklus des Medizinprodukts anhand von klinischen Daten zu aktualisieren, die aus der klinischen Nachbeobachtung und der Überwachung nach dem Inverkehrbringen stammen.
SAE reporting in the age of digitalisation (eSAE)
The use of electronic data capture (EDC) and electronic case report forms (eCRF) is becoming the gold standard in clinical research. Today, the dream of a paperless (or at least near-paperless) study seems within reach [...]
User-friendly eCRF-design: the key for successful data collection
To ensure a perfectly suited eCRF design many different aspects have to be taken into account also with regard to user-friendliness [...]