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Artificial Intelligence (AI) in clinical research: transformation of clinical trials and status quo of regulations
Artificial Intelligence (AI) supported technologies play a crucial role in clinical research: For example, during the COVID-19 pandemic the Biotech Company BenevolentAI found through a machine-learning approach that the kinase inhibitor Baricitinib, commonly used to treat arthritis, could also improve COVID-19 outcomes.
EU CTR: How to write a good Lay Summary of clinical study results
Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research.
Simply explained: Drug approval procedures in Europe and the example of COVID-19 vaccines
Summary: There are three different marketing authorisation procedures in Europe: the Centralised Procedure (CP), the Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).
Electronic informed consent (eConsent) in clinical research in Europe: opportunities and bottlenecks
While eConsent has become a reality in the US, Europe is still lagging behind in its implementation. To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.
DIN EN ISO 14155:2021-05 – Der neue Standard zur Guten klinischen Praxis für klinische Prüfungen mit Medizinprodukten
Welche Neuerungen sich durch die Überarbeitung der DIN EN ISO 14155 ergeben und auf welche zusätzlichen Aufgaben müssen sich Sponsoren gefasst machen sollten.
Synergieeffekte bei Zertifizierung und Erstattung digitaler Gesundheitsanwendungen
Zwei Expertinnen für Zertifizierung und Erstattung – ein Ergebnis ihres Gesprächs: Gut geplant können Synergien in den beiden Prozessen genutzt werden.