RESCUE CASE STUDY: Pandemic Pivot to Remote Monitoring
An ongoing multi-year, Phase IV infectious disease clinical trial involving more than 3,000 participants for which Stiris Research was providing full service clinical trial management was adapted in order to keep the study on track when the COVID-19 pandemic hit.
Due to the COVID-19 pandemic and the need to keep this trial running, the study was forced to shift from onsite monitoring to remote monitoring. While some sites had secure portals where the CRAs could 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 new and require dedication to learning and adapting to new technology.
Beyond the technological hurdles, there was a major demand of time that could be a schedule restraint while everyone learned the technology and ensured they could access the records so that remote monitoring could occur.
Stiris tapped into their well-developed rapport and relationships with the sites. These relationships allowed for Stiris to collaborate with the sites and make easy work of the logistical conversations necessary so information on remote monitoring feasibility could be quickly assessed. During the transition, Stiris was able to continue collecting data through encrypted emails and conducting video Zoom calls.
During virtual visits, Stiris trained the sites on new technology, guided them on virtual monitoring processes, and navigated through and overcame the pain points that arose throughout the process. Thus, allowing the Stiris CRAs to review IP, storage rooms, Lab & EKG supplies, ISF binders and perform source document verification.
This process nurtured relationships with the sites allowing for the Stiris team and the study sites to remain flexible to each other’s needs.
Since patients were not coming to the site as often, care packages were sent providing them with the proper tools to keep the study wound site clean.
- Due to the flexible and scalable nature of Stiris. The project team was able to rapidly evolve to the situation.
- The Stiris PM, CPA and CRAs are strong communicators and worked diligently with sites to identify remote monitoring needs and possible efficiencies.
- Despite pandemic-induced hurdles, the study was able to stay open and on track and complete enrollment.