Request from Sponsor
Real world evidence data collection of about 200 subjects in 7 European sites. Data needed to be collected and collected within 5 months of assignment awarded.
Our Solution
The challenges that we were facing were the delays in contract finalization which were at sponsors responsibility. All ECs wanted to have a traditional review of the study with the consequence that EC approvals were received within 2 months of submission, nevertheless still before contract finalization.
With these delays operationally, we were faced with a period of 3 months data collection and cleaning, which put additional stress on the research nurse at site. As we would like to honnor our patient centric and site centric approach, this meant that we would need to involve our site support team so that the pressure is off the site team.
Proactively (and in close communication with the study coordinator on site) our site support team worked together to gather the information already on specific forms as the EDC system could only go live once all approvals and finalizations were in place so that initiations could be performed.
As part of the site team our team was able to gather the information on these pre-prepared forms and was able to enter all the data in the EDC once everything was in place.
The above-mentioned challenges caused a slight delay in the quality process of the entered data, nevertheless still before the deadline set by the Sponsor. This was thanks to the good planning and communication with the Sponsor by our Project Manager and SSL Coordinator.
We would also like to emphasize that in collaboration with the Sponsor the clinical study protocol and the EDC was set up. This created the opportunity to engage the site within the set-up of this project and to avoid redundant queries. For the site this meant a big difference in how to handle queries and the amount of queries.
Outcome
A next project was awarded as the Sponsor considered a high quality of data was collected. This also reinforced the trust with the site to work together on the next assignment in the same way.