Medical-scientific committee and DSMB: two key bodies for ensuring the safe clinical development of a medical device. Roles, composition, and regulatory issues.
The essential role of medical-scientific committees and other committees of interest Read more »
The PSUR medical device: regulatory requirement MDR 2017/745 for Class IIa, IIb, and III MDs. Content, frequency, and challenges for manufacturers.
The PSUR: a complex puzzle with multiple dimensions Read more »
The digitization of clinical trials is advancing in France: pilot phase open for 20 projects. Dematerialization, rSDV, decentralized trials—regulatory framework and opportunities for sponsors.
Digitization of clinical trials in France: the window is open! Read more »
Adaptive designs allow a clinical trial to be modified based on interim results, while ensuring scientific validity and patient safety.
An adaptive design to optimize clinical investigation Read more »
The master protocol pools resources and infrastructure for multiple clinical investigations. This modular approach accelerates development and meets the requirements of the MDR regulation.
Master protocol: a pillar for structuring clinical investigations. Read more "
The PSUR becomes mandatory for Class IIa and higher medical devices under MDR. Find out how to structure this safety report and turn it into a strategic asset.
MDR Regulation: everything you need to know to write a compliant PSUR. Read more »
Biostatistics transforms raw data into robust clinical evidence. Discover its role in study design, data analysis, and benefit/risk assessment of medical devices.
The importance of biostatistics in clinical research Read more »
