By Blake Adams, VP of Marketing and Growth for Florence
90% of clinical trial sponsors rely on some form of remote monitoring. This statistic makes reliable, efficient remote site access more important than ever. Through our network of 10,000 study sites in 44 countries, the Florence eHub platform now facilitates more than 3 million monitoring actions every month (as of October 2021).
Florence eHub’s growth has more than doubled for the past two years, and our new clients have given us better insight into how remote site access helps sites and sponsors.
How can always-on remote site access benefit your research organization? We’re seeing the following metrics:
1. Higher Site Adoption of Technology (95%+ activation rate)
Clinical trial sponsors struggle to drive site adoption of their new technologies. Documents are loaded into the system slowly at best, and the site never makes use of the platform at worst.
What’s going on? Despite being disguised as a site technology, the technology wasn’t designed for the study site: it was made for the sponsor. This won’t work.
Florence eHub delivers a 95% site adoption rate, with most sites fully functioning within 6 weeks. What’s the secret? For the past eight years, we’ve developed the world’s best electronic investigator site file (eISF), which is now trusted by 10,000 study sites across 44 countries.
Sites love our platform. This means sponsors can conduct studies faster. Sponsors and CROs will also benefit from more accurate documents, quicker form exchange, and the chance to use real-time remote monitoring throughout the study.
2. Increased CRA Utilization Rate (52 sites monitored per week)
Because of high rates of burnout, recruiting and retaining CRAs has become increasingly difficult. At the same time, the enormous amount of documentation generated by modern clinical trials is impossible to comb through manually or by using disjointed systems. So what happens? Overwhelmed monitors can’t visit sites as often or check on as many documents as they would like to.
Florence eHub allows top CRAs to monitor 50 sites remotely per week. The eISF provides direct remote access to sites as well as a dashboard that lets CRAs move between sites in a flash. Instead of looking at hundreds of documents, CRAs can use Florence to identify which sites, and more importantly, which documents, to focus on each day.
What’s the result? The site produces more complete, timely, and high-quality documents.
3. Higher eTMF Quality
CRAs spend days performing quality control for site documents. When sponsors and sites use disjointed systems to complete and maintain these documents, quality control becomes even more time-consuming for both sides. Before moving to Florence, one of our key site clients was seeing an average pass rate of just 65% for their regulatory submissions.
Florence eHub allows sites to receive, complete, sign, and submit all documents in one place. These documents can then be QC’d and routed directly into the sponsor eTMF. As a result, the consistency, completeness, and quality of the documents improves. With the help of Florence, the same site client now achieves an average regulatory submission pass rate of 98.7%.
4. Faster Site Activation Timelines
The study start-up process takes a long time, and much of this time is spent on document management with the study site. One Florence customer reported an average start-up time of six months. Ultimately, slow start-up times result in delayed findings, longer lag times before sponsors can determine whether they need to find replacement sites, and the risk of not being first to market.
Sponsors can use Florence to distribute documents to all of their study sites at once, ask sites to complete all documents electronically, and then manage those documents remotely. In Florence, the average signature time is less than 100 hours. By taking advantage of that and high site adoption rates, the above sponsor was able to reduce study start-up time to an average of 18 days.
5. Remote Monitoring and Source Data Verification
Even when using a risk-based monitoring strategy, the CRA needs to conduct source data verification. The process can be done remotely but normally requires logging into a variety of systems, such as an EMR/EHR. Using remote monitoring across multiple systems delays the process significantly and increases the site’s workload and that of its sponsor.
When sites use Florence eHub, regulatory data, source data, communications, logs (DOA, Financial Disclosure, AE, SAE), and consent forms are all synched into one place for the monitor to access. Sites can employ front-end integration across their entire software suite, no matter what tools they choose. They can then route all of their data to Florence in a single click. This gives monitors real-time access in a compliant and permission-controlled environment.
Embracing Remote Access Across Sites and Sponsors
COVID forced sponsors and sites to collaborate virtually. Florence helped this collaboration expand beyond basic electronic document exchange to a fully integrated ecosystem that delivers lasting results.
The relationship between the sponsor and site remains as crucial as ever, even as decentralized trials, virtual trials, hybrid trials, and agile trials expand. Florence makes this relationship stronger.
We can get you up and running with remote site access, monitoring, and SDV quickly. Our team can also help you see which sites that you work with are already on our platform and how your CRAs are using Florence for remote monitoring today.
Want to learn more? View the Florence eHub on-demand tour here.