A global study with 37000 patients has closed recruitment one month ahead of schedule. This is an extraordinary acheivement. We are very proud to be part of this achievement because it shows team work globally.
The study started in 2014 with first patient in in October 2014. We have 50 countries over 4 continents and >400 sites on board.
In this study we adopted the CRA Liaison on a larger scale. The CRA Liaison performs remote monitoring activities and works in close collaboration not only with the CRA’s but cross-functionally (data management, biostatistics) and the sites. To ensure that the sites present good quality data the CRA Liaison is in close communication with the CRAs. CRA’s visit sites based on the RBM approach.
We learned that for such a large study it is really important that all team members work closely together to be able to handle the large data that is generated in this trial.
Thanks to our great team work, good communication, leaderhip, strategies we are able to accomplish the other milestones set forth in this trial e.g. remote monitoring of key data, reviewing all safety data and ensuring timely adjudication, limit the amount of queries thanks to close collaboration with the sites.