Case Study - Phase IV - Monitoring & Regulatory Affairs
SCOPE OF WORK
Phase IV study requiring full Monitoring support (including Regulatory Affairs) in Netherlands.
A phase IV study to compare the two available medications in the market.
THE CLINTEC APPROACH
The sponsor decided that this study required the role of a local monitor. They chose a member of the team who not only had the experience, but the flexibility in their schedule to visit the clinics to monitor and collect all the data and transfer it to the sponsor immediately. By using this set-up, the monitor was close to the data and could be responsive to all the sponsor’s requests. This also kept the communication channels for the study very tight, with the project manager being able to effectively liaise with the sponsor and study sites to maximize patient recruitment.
This has been an excellent example of how Phase IV studies should work, with intensive cycles of monitoring and decision making after the recruitment period.