Mini-Case Study – A COVID-19 Rapid Response Story
We all know adjusting to the new reality with COVID-19 has been challenging, but it hasn’t been without its rewards. Last week Trifecta Clinical quite literally “answered the call” from a top 10 pharmaceutical company looking to launch an observational Coronavirus study in 24 hours. No, that’s not a typo. Think Jack Bauer, but behind a desk, and the threat is a real life scenario that affects the globe. Knowing the critical importance of this project we sprung into action. And we’re proud to be working on this project free of charge as part of our announced Coronavirus donation pledge.
The timeline went as follows: (This is where you play that Jack Bauer countdown clock in your head.)
Thursday 3:40pm – Trifecta Clinical answers the call. “We can make that happen!”
4:30pm – The project team is selected and notified.
Friday 10:00am – Kick off Call with Study Team – The briefing covered an observational study in Indianapolis that is designed to estimate the number of SARS-CoV-2 infections in a population of people presenting without symptoms for COVID-19 at time of testing. The study requires 3000 subjects, which will be screened and then processed via a drive-thru testing facility. Follow-up to be provided on positive cases to see if symptoms develop.
11:30am – Configure Training Requirements in InvestigatorSpace – The study required two user groups each with custom training curriculums. Principal Investigators and Call Center Associates would need to be certified on different aspects of the study. This was configured in InvestigatorSpace to allow tracking of compliance and make training easy to report and monitor.
1:00pm – Secure Training Content – Working with sponsor’s content owners we were able to construct protocol overview training via click through presentations. A GCP Training (Good Clinical Practices) module was also included in the training curriculum.
4:00pm – User Management – Due to the rapid nature of this project, we implemented a two front approach to adding investigators. First a simple list upload into InvestigatorSpace to bulk create new accounts. Second, we enabled a self registration process where principal investigators could sign-up via an online web form which triggered notification to study managers, which in turn, allowed them to approve and provision the study account.
8:00pm – Final Review – Even on short notice, all studies need to go through our quality assurance process to verify everything is in proper working order. Green checks across the board and we were ready to go.
10:00pm – Launch – The study launched Friday night just before 10 PM. A record 12-hour turnaround time from kick off to launch. All training was immediately available through our InvestigatorSpace platform. We received, configured, staged, reviewed, QA’d, and launched the training as per standard Trifecta Clinical SOPs in record time.
Sunday – As of Sunday evening, there were 13 investigators, with certified training, active in the study.
Monday – Extra Credit – A virtual investigator meeting was held and recorded that added extra levels of clarification from the sponsor plus answered any questions about the study. This training was also made available on-demand within the platform.
While we always take a great deal of pride in our work, given the nature of this study, we were privileged to have the opportunity to contribute first-hand to a possible solution to the current crisis. We believe this initiative will have a profound positive impact and we are excited to have this rare opportunity to work alongside our client. Thank you to all my fellow Trifecta employees for confronting the challenges of COVID-19.
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