BfArM Guidance on Statistical Requirements for Clinical Trial Authorization
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
The article addresses the aspects related to the fees payable by the interested parties and also provides definitions of the most important terms and concepts.
The new article highlights the aspects related to the timeframes the applicants should follow.
The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.
The new article highlights the aspects related to the timeframes the applicants should follow.
The new article outlines specific requirements to be considered depending on the study type or design.