Large-scale national registry on the safety and tolerability of a contrast agent, involving more than 3,000 patients across more than 500 hospitals
Background:
A clinical study on the safety of a contrast agent was conducted nationwide in the field of medical imaging. The registry aimed to document the tolerability and safety of a contrast agent used in routine clinical practice.
Conducted in more than 500 hospitals in France, the programme followed more than 3,000 patients, creating a database notable for its size and the diversity of the participating institutions.
This national medical imaging registry required rigorous coordination to ensure the quality, comparability and traceability of the information collected.
Challenges identified
The project presented several major challenges:
These logistical and scientific constraints called for a methodical approach and effective tracking and reporting tools
Pharmaspecific’s role
In this clinical study on the safety of a contrast agent, Pharmaspecific contributed to the quality and traceability of the safety data collected from the participating hospitals. This approach is in line with the medicines monitoring principles set out by the European Medicines Agency (EMA), particularly with regard to pharmacovigilance and adverse event follow-up.
Results
