Time to celebrate as the PLUS Trial has begun taking enrolments.
For the team at The George Institute and us here at Spiral, it’s a major milestone. Enrolments mean the completion of the development stage and advancement towards the target of enrolling 8,800 patients.
Enrolments also mean the first shipments of study treatment have been delivered. The ordering process, the receipt of shipments at each hospital and then resupply are all handled via our software, Spinnaker.
To reach this point we do a lot of testing of the software and the database used in the trial. Bryn was kept busy for weeks checking that Spinnaker matched what was requested, after which the team at The George Institute got stuck in and tested the clinical side of things. Enrolment time for us is about making sure everything is ready including:
- setting up the monitoring
- cleaning up the database
- making sure we are available for technical support on go-live day
- copying the project to a development server so we are ready for any upcoming changes or issues
Once the project is “live” and enrolling patients, our work is not finished, we:
- continue to monitor the response speed and activity on the project
- monitor for teething problems
- do extra testing to double check everything is running smoothly
- monitor and manage the servers that host the study software and database
We also have some clever automations that run in the background and make sure things are ticking along with the trial.
We do this for each project and PLUS was no exception.
Congratulations to the PLUS team at The George Institute and to all the sites participating in the early enrolments. Today, 25 patients are enrolled with only 8,775 to go!