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Post-Market Clinical Follow-up zur Generierung klinischer Daten nach Inverkehrbringen
Warum wird die klinische Nachbeobachtung, das sogenannte Post-Market Clinical Follow-up (PMCF) so wichtig im Rahmen der Überwachung nach dem Inverkehrbringen? Welche Möglichkeiten gibt es, PMCF durchzuführen, und welche Bedeutung haben die Ergebnisse aus dem PMCF für die klinische Bewertung nach Inverkehrbringen?
eCRF mit integrierter ePRO Lösung– native App vs. browser-basierte Variante
Der digitale Fortschritt durchdringt das tägliche Leben in allen Bereichen. Die getroffenen Maßnahmen im Zuge von COVID-19 haben dazu beigetragen, dass diese Entwicklung vor allem im Gesundheitsbereich noch verstärkt wird.
The course of a pandemic – epidemiological statistics in times of (describing) a crisis, pt. 2
A few weeks into the pandemic, the RKI switched its main reporting indicator from the absolute case numbers to the time dependent case reproduction number R(t). R(t) represents the number of unaffected persons that are infected by an index case.
The course of a pandemic – epidemiological statistics in times of (describing) a crisis, pt. 1
Throughout the current Corona pandemic, epidemiological statistics are widely used in everyday life to an unprecedented rate. Various media use different indicators for all kinds of purposes, be it the honest attempt to objectively communicate the risk associated with SARS-CoV-2, or in order to up- or downplay the mortality rates.
Clinical prediction models in the COVID-19 pandemic
Facing the world-wide spread of coronavirus disease 2019 (COVID-19) infections with hospitals overcharged and a shortage of medical equipment in several countries, diagnostic and prediction models might help to identify patients with COVID-19 and predict the likelihood of the disease outcome (e.g. severity of disease, recovery, death).
Investigator Initiated Trials (IIT)
Can they demonstrate scientific merits and align with corporate objectives? Often initiated by researchers or investigators as a part of an observation, an Investigator Initiated Trial (IIT) or Investigator Sponsored Trial is one of the kind of clinical trials that take up specific questions from clinical care, such as therapy optimization or off-label use, and are usually of no economic interest.