Blog
High-Quality Surveys (HQS) under the MDR – A Concise Overview
High-Quality Surveys (HQS) are an elegant type of study, increasingly used by medical device manufacturers to support the Post-Market Clinical Follow-Up (PMCF) activities required by the European regulatory framework.
45 Jahre GKM Gesellschaft für Therapieforschung mbH
45 Jahre GKM Gesellschaft für Therapieforschung mbH: Ein Unternehmen der Forschungsdienstleistung im Spiegel der globalen und nationalen Gesundheitspolitik
Machine versus human: Can Koda replace expert drug coders?
Exploring how WHODrug Koda performs in real‑world clinical data workflows: strengths, gaps, and what still requires human review.
IMPs vs. AxMPs: What’s the Difference and Why Does It Matter?
In clinical trials, distinguishing between Investigational Medicinal Products (IMPs) and Auxiliary Medicinal Products (AxMPs or AMPs) is essential for regulatory compliance, robust trial design, and patient safety.
Das Forschungsdatenzentrum Gesundheit – eine neue Datengrundlage fürs AMNOG Verfahren?
Mit dem neuen Forschungsdatenzentrum Gesundheit (FDZ Gesundheit) werden die Abrechnungsdaten der gesetzlichen Krankenversicherungen erstmals zentral für datengestützte Gesundheitsforschung nutzbar gemacht.
Real-World Evidence
Real-World Evidence (RWE) is clinical evidence regarding the use, potential benefits, and/or risks of a medical therapy. It is derived from the analysis of real-world data (RWD).