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.
Contrary to the outdated image of the non-interventional study (NIS) as a pure marketing instrument, this kind of study is particularly suitable for emphasizing the effectiveness, efficiency and safety of a drug under real life conditions. A quick guide for the planning of your NIS.
Although not yet brought into daily clinical routine, new screening methods and individualized pharmacological treatment concepts are under evaluation and show promising first results. Three recent findings describe the advances in research for breast, prostate and pancreatic cancer.
Die Medizinproduktestudie als Variation der Arzneimittelstudie? Im Detail zeigen sich Unterschiede, die sich grundlegend auf Design und Auswertung einer Medizinproduktstudie auswirken können.