After attending the 2020 TMF Summit in Orlando, Ryan Jones, CEO of Florence, gathered his thoughts and provided key takeaways that are transforming the clinical trial ecosystem.
Executive Summary: Trial operations now center around on connectivity, not visits. New categories of interconnected tools are helping the industry get there.
Executive Summary: Trial operations are now centered on connectivity, not visits. New categories of interconnected tools are helping the industry get there.
The foundation of Sponsor/CRO clinical trial site relationship management is the CRA site visit – with visits anchoring key milestones like feasibility, startup, and monitoring,
Because site visits tend to focus on data/document collection and verification, and tend to be delayed, we heard at the 2020 TMF Summit in Orlando that CRAs are left little time to think proactively about solving bigger challenges.
However, we also heard that technology is transforming this dynamic as it allows CRAs to move beyond basing their site relationship on the site visit, for instance:
The average site spends 768 hours per year filling out feasibility surveys. A digitally connected site can have these data and documents ready in their own system for a sponsor to consume and analyze.
The average (oncology) site spends 200+ days in study startup. A digitally connected site can be presented auto-completed documents that simply require review and signature.
The average site gets inundated with queries and tasks around an in person monitoring visit. A digitally connected site can have an ongoing dialog with CRAs in a shared online workspace.
At Florence, we’re able to measure how far the industry has come in connectivity. In January 2020, Sponsors collaborating with sites accounted for 47% of the more than one million feasibility, startup and monitoring actions across the Florence platform.
So if this digital site-sponsor connectivity is happening, what did we hear at the 2020 TMF Summit about how it is happening?
Three interconnected eClinical products make site-sponsor connectivity possible for the first time.
eTMF – Electronic Trial Master File solutions have been around for 20 years. Historically, sponsors relied on eTMF tools only for internal document tracking and categorization – collaboration with research sites was relegated to upload portals. At the TMF Summit, we heard enthusiasm for site connectivity and capabilities that enable site to sponsor workflows. Florence offers Florence eTMF.
eISF – The eISF (Electronic Investigator Site File) is the mirror-image of the eTMF. It enables document tracking, categorization and workflows for the site. Relatively new, the value of the eISF is apparent as 61% of research sites plan to have one in place by the end of 2020. Florence eBinders is widely recognized as the world’s leading eISF with over 6,300 active research sites as of January 2020.
eTMF – eISF Connector Solutions – It is clear that Sponsors/CROs are no longer content with isolated eISFs and eTMFs and see the value of seamless data/document exchange between the two. Connectivity platforms like Florence eHub and the Shared Investigator Platform (SIP) are now a reality for the first time ever to link existing eTMFs to the eISF.
Site-sponsor connectivity around documents can work in two ways:
1) Connecting Seperate Platforms Across Stakeholders
Each of the three key platforms (eTMF, eISF, and Connector) comes from a different vendor. This model allows for the flexibility of each stakeholder selecting the platform the best suits their needs and in instances where each stakeholder may already have a system they do not want to abandon. A central platform like Florence eHub can then integrating these separate site and sponsor systems via APIs.
2) Single Document Centered Integrated Platform Across Stakeholders
All three components are delivered by a single vendor, such as connecting the Sponsors using Florence eTMF to sites on Florence eISF via Florence eHub. This approach will deliver a better total user experience across modules, but you may run the risk of lacking some advanced features in each individual product.
What else did we hear at the 2020 TMF Summit?
Beyond observing site connectivity coming of age, the Florence team noted artificial intelligence (AI) for document processing as a maturing area of innovation. Here, sponsors focus on replacing the manual categorization and tagging work required for eTMF assembly with automated categorization from AI.
Discussions focused around which applications AI is well-suited for, and which it is not. And an acquisition was announced, with PhlexGlobal buying Cunesoft—we see these pragmatic events as a sign that AI is now a usable technology, not just a science experiment.
The winning solutions for site connectivity will exhibit the same characteristics as the best eClincal applications that have come before—they must be compliant, reliable and easy to use.
Look for announcements in 2020 to come as the best sponsors and CROs begin picking their site connectivity partners.
Learn more about Florence eHub, the first eTMF – eISF connector with more than 6,300 active research sites.