We met the sponsor through a common contact. After a teleconference and some emails, they came to meet us from the US and we immediately got along.
As in any relationship, we first laid the foundations: budget, conditions, negotiation and contract.
Then, we started working on a very nice project in advanced therapy. One of those that make you feel proud to be in this sector.
After a year working with them, the sponsor told us that they URGENTLY needed a partial closure of the database to obtain the marketing authorization in Europe.
We only had 3 months to include all the data in the CRF, monitoring it and close all queries for 317 patients.
If the report was not ready for the deadline, the study could be terminated.
We had to change the strategy and get to work or we could not reach the deadline.
And so we did it.
We went from 2 monitors to 24 people (22 monitors and 2 data entries) working on the study.
The monitoring visits were increased overnight. During 3 months we did on site monitoring EVERY DAY and in many of those we met the 24 of us at the site.
We literally lived in the hospital!
Truth be told, it was very stressful.
But it was also very cool, and the well-deserved party we had at the end of this milestone was epic.
I’m not saying everything was perfect. It wasn’t. But we are very proud of the work we did, proud of the team and proud of the response we had.
The sponsor ended up very satisfied and to this day we continue working together on other projects.