by Blake Adams, Sr. VP of Marketing, Florence
The first three months of 2022 have seen a 3x uptick over the first three months of 2021 in clinical trial sponsors and CROs contacting Florence about deploying Electronic Investigator Site Files (eISFs) to their study sites.
These sponsor/CRO-driven initiatives help sites digitize and standardize their Investigator Site Files, regulatory files, and often source files and workflows on a central platform. With eISFs, sites maximize efficiency and enable remote linking with their sponsors’ and CROs’ workflows.
So why are sponsors prioritizing eISFs in 2022, in particular? Here are the five most common reasons we hear:
1. The eISF is now mature, fully replacing the “site-portal” model that disrupted sites.
The past eight years have seen an evolution in how sites manage, store, and interact with clinical trial documentation.
Sponsors began offering site portals and document vaults in mid-2010, allowing one-way uploads of site documents into sponsor systems. As noted in the Florence 2017 white paper on the impact of remote monitoring, the move to sponsor portals increased the burden on site staff, with sites indicating 40% more work associated with “remote monitoring.”
In 2019, sites began to realize the importance of investing in site-wide Electronic Investigator Site Files (eISFs) to standardize their operations, with over 4,000 investigator sites activating their eISF on Florence eBinders that year.
At the time of this writing in March 2022, close to 12,000 study sites in 46 countries use Florence eBinders as their eISF. The Florence 2022 State of the Industry Report revealed that 87% of all sites plan to have an eISF solution in place by year’s end.
What is the significance of this? It is now possible for sponsors to deploy full-featured eISFs at their study sites that feature the tools sites need to complete their tasks. A platform like Florence eBinders, which can manage electronic signatures and audit trails as well as permission controls and remote access, provides sites with everything they need to succeed.
2. Sponsors no longer have to worry about site adoption: ease-of-use makes an eISF an easy choice for sites.
“Sites’ adoption of technology” continues to rank as a top barrier to sponsors successfully driving digital transformation plans, with 36% of sponsors ranking it as the top barrier to technology investments in the Florence 2022 State of the Industry Report.
However, with the rise of eISFs that focus on site needs first, sponsors are now seeing nearly 100% adoption and activation rates among sites. Site activation has gone from taking several months to taking less than 1 month for 95% of sites.
Sites rank Florence as #1 out of 291 clinical trial platforms for ease-of-use, ease of setup and quality of support. By thinking about sites’ needs, Florence Healthcare has been able to help sponsors ensure adoption at their study sites.
With high adoption rates across the portfolio, sponsors are able to accelerate study start-up by as much as 40%–which also means 40% faster start-up for sites. Additionally, sponsors can centralize all of their site monitoring, enable continuous and always-on access to sites, and implement modern protocols that enable non-traditional sites to participate in research.
3. COVID forced sites to adopt new technology-driven approaches.
While the move to eISFs was happening pre-COVID, sites mostly followed the same processes they did when using paper. . Almost overnight, COVID forced them to move into a digital-first world and to rework their processes to take full advantage of electronic systems.
We witnessed this transformation firsthand at Florence as research centers moved regulatory staff off-site, restricted on-site monitoring, and remotely deployed patient-focused technologies like eConsent.
After two years of sites tinkering with these rapid changes, we now see the changes sticking around and maturing further. Sites continue to take a remote-first approach both with their team and with their sponsors, because this approach allows them to speed up their study timelines.
A digital workflow centered around the electronic Investigator Site File gives sites unprecedented efficiencies – accelerating study startup times by more than 40%, enabling multi-center trials, activating fully remote monitoring for sponsors and CROs, and providing the capability for teams to work remotely.
4. Sponsor CRAs became accustomed to remotely working with sites during COVID.
As site staff did, CRAs at a majority of sponsors and CROs quickly adapted to working in a digital/remote-first environment almost overnight.
It has become common practice for CRAs to log into research sites’ systems remotely, have always-on access to documents, and connect directly with sites when needed without having to fly, rent a car, or stay in a hotel. Florence SiteLink alone facilitates more than 3.8 million remote research workflows every month.
A majority of sponsors and CROs now have CRAs monitoring enterprise study sites on the Florence platform. As a result, when the sponsor chooses to roll out Florence eBinders eISF through Florence SiteLink, a large portion of the CRA team already knows how to work the system.
When sponsors roll out the eISF across their site portfolio, they realize significant benefits, including optimized CRA efficiency so they can monitor 50+ sites per week, faster document cycle times, reduced overhead, and ultimately, faster study timelines.
5. Decentralized trials require the digitization of the site and sponsor link.
As covered in this previous article on digitizing the site network for decentralized trials, the push to decentralized trials is accelerating. Survey data from WCG Avoca indicates 89% of clinical trials will feature hybrid elements in the future.
In these hybrid studies, the role of the site will evolve but will not go away. That means that sponsors will still need a way to collaborate with the study site, whether the site is also running the DCT elements or not.
The eISF is the obvious choice for enabling this hybrid trial by serving as the digital link between the site and the sponsor/CRO. By digitizing the eTMF as well, many sponsors have been able to load documents directly from sites’ eISFs to their eTMF. But the most important factor is that sites have an eISF that they control, that works for their needs, and that they can use to share documents with their sponsors.
Is an eISF initiative right for your study?
While every clinical trial organization is unique, an eISF initiative can help nearly all of them. For large sponsors and CROs, the eISF helps standardize and maximize the effectiveness of their workforce. For emerging and mid-sized organizations, the eISF helps them scale their workforce and gain competitive advantages.
Sponsors are seeing clear results on study speed, activation timelines, site satisfaction and CRA effectiveness.
If you’re considering deploying Electronic Investigator Site Files (eISFs) to your study sites in 2022 or would like to understand more about what the eISF does, let our team know. We can give you an inside look at Florence’s SiteLink and eBinders platform, the #1 rated eISF in the industry, help you understand how sites are using the eISF today, and walk you through strategies other sponsors are using to get started.