Pandemic Pivot to Remote Monitoring
Background
Stiris Research was brought in to rescue a global phase II/III rare disease clinical trial providing project management, monitoring, TMF, and vendor support and then a few months later the COVID-19 pandemic hit.
Challenge
IMPACT OF GLOBAL PANDEMIC ON SITE BUDGETS, REMOTE MONITORING COSTS, ETC.
Due to the COVID-19 pandemic and the need to complete this trial for this rare disease population, the pivotal study was forced to shift from onsite monitoring to remote monitoring. While some sites have secure portals where the CRAs can log in (time-sensitive access) to gain access to the EMR for source document review, for many other sites, remote monitoring was going to be more time-consuming as documents had to be redacted and scanned prior to sharing with the CRA.
For sites that would still permit onsite monitoring during the pandemic, COVID tests were often required and not paid for by the facilities. Thus, incurring additional costs that were not originally budgeted for.
Solution
RESPONSIVE COLLABORATION and RAPID ADAPTATION
Stiris relied heavily on their well-developed rapport and relationships with the sites to make easy work of logistical conversations to rapidly obtain information on remote monitoring feasibility. Stiris approached each site to assess their remote monitoring capabilities and capture the appropriate fees for conduct of remote monitoring in their site budgets.
The well-developed relationships with the sites enabled the CRAs to pursue remote monitoring in the pandemic. The monitoring plan adaptations were constructed in such a way, that the remote monitoring approach could be toggled on and off as the pandemic exposures and vaccine development effected guidelines and protocols.
Stiris builds solid CTA amendments/templates for every study, so when the budget had to be amended – it was easily adapted. COVID tests were added as a pass through to the Work Order with the client.
Results
- Due to the flexible and scalable nature of Stiris. The project team was able to rapidly evolve to the situation.
- The Stiris PM and CRAs are strong communicators and exercised their good rapport with sites to identify remote monitoring needs and work efficiently at updating budgets/contracts
- Successful inclusion of remote monitoring fees, fees for conduct of hybrid visits, on-site COVID testing, etc. into site budgets