Service Description

Tasked to ensure timely enrollment of the study, also to have monitoring of the data and high quality timely data retrieval from sites.

What Went Well

The enrollment after a slow start, picked up and the study was completed on time. Regarding monitoring and quality of data, again, after initial hiccups, they were able to change the team (CRAs) and refreshed the training resulting in high quality data

What Could Be Improved

Monitoring of the data is an example. Initially lots of queries and missing data, not handled properly. Resulting in some CRAs changed on team and than two refresher trainings conducted. also decrease the number of sites per CRA from 8 to 5 helped.

Lessons Learned from the Experience

Most of the thinking was aligned, where its typically to have changes on team if one CRA doesnt have the right background or has issues in terms of site relationship. Similarly the travel schedule etc eased a bit after they reduced the site burden.