Request by client
In this specific case study the client is not the Sponsor but an independent Clinical Research Site. It was at the start of the pandemic in 2020 that this research site experienced issues with available site staff and the fast pace of the data entry. Based on a regulatory inspection the research site approached us for following challenges for a covid-19 project in 1200 patients:
- Delay in data entry
- High number of queries
- Additional covid-19 study
- PI oversight and overall quality
Solution provided
We compiled a team of 10-15 site support liaisons to help first with the data entry and query resolution. 1 Part of the site support team was occupied with the backlog: Delay and backlog in data entry and query resolutions was catched up in barely less than a week time. At the same time the other part of the team ensured data entry within 24 hours of new patients in the new additional covid-19 study.
This team also made sure that all queries were resolved and timely meetings were set up with the data management team of the CRO managing the study at that research site for the Sponsor.
With this approach our team managed to proactively avoid/respond to all queries and guide the Sponsor as well on erroneous queries.
After these activities were catched up and under control, time was also spent on verification of the eISF and ensuring all essential documents were corrected and completed as needed.
With our built in quality process the inspectors request on improvement of overall quality was met for the points that our team was responsible for.
Our SSL supported the PI and sub-investigators and were able to support in a better oversight of their site and the activities in these busy times of covid-studies.
The challenges that we could encounter with the SSL team was that the on site team felt a bit overwhelmed by the activities that the SSL team could take over. After our SSL lead could coordinate and communicate in an efficient manner with the clinical research coordinator responsible for that study, we could see and notice an increase in patient recruitment, patient retention and how the on site research nurses were able to focus on the patient in a more efficient way.
Outcome of this collaboration
Set up a remote data entry process compliant with all applicable regulations.
We are able to perform data entry within 48 hours of the patients visit.
There was a significant reduction of queries and protocol deviations.
Based on the above we were able to expand these services to all trials in that respective clinical research site.