September 13th, 2022 – Boston, MA – Today at DPHARM 2022 in Boston, Florence Healthcare announced it is investing in how clinical research sites and sponsors collaborate to advance cures by opening its SiteLink™ platform to connect with any site-based electronic Investigator Site File (eISF) or eRegulatory system.
“A clinical trial’s success entirely depends on the success of the research sites,” says Catherine Gregor, Chief Clinical Trial Officer of Florence and former Director of Clinical Research Administration at a cancer center. “These sites, however, are often forced to abandon long-established workflows they’ve perfected for years because the sponsor chooses its own tool for a single study. In turn, the site must sacrifice efficiency and patient engagement to make time for duplicate work and learning new systems not designed for their needs.”
According to Florence Healthcare’s 2022 State of the Industry Report, the average clinical trial site logs into six different platforms for each study they conduct. A major academic medical center conducting hundreds of trials can suffer from thousands of duplicate workflows and failure points, as well as hundreds of lost patient engagement hours.
“Clinical research technology is fragmented, increasing drug development costs, stalling the FDA’s push for diversity in clinical trials, and ultimately delaying cures for patients,” says Ryan Jones, CEO of Florence Healthcare. “We can’t fix disconnected systems through a uniform platform – each research site has vastly different needs requiring different tools. Only using an open API to link sponsors’ tech with sites’ existing tech can solve this problem.”
The most common existing site tech is the eISF, which is now at more than 89% of large research sites, according to Florence’s 2022 State of the Industry Report. Outside of those large research organizations, however, the prevalence of an established eISF drops to 30%. This especially affects “frontier sites” that are new to research, like pharmacies, labs, and doctors’ offices, preventing true collaboration.
Many clinical trial technology vendors have addressed this problem by trying to pressure sites and sponsors into using only their platforms for studies. This ignores the needs and preferences of research sites, especially those who already have an eISF.
“We wanted to come up with a solution that works for sponsors and CROs, for sites who already have an eISF, and for frontier sites who don’t,” says Jones. “That’s why we chose to give SiteLink an open API.”
Florence Healthcare’s SiteLink™ was introduced in 2019 and became the backbone of many COVID-19 studies in 2020 when digital links between sites and sponsors were essential. As SiteLink matured, sponsors quickly began using it to connect most of their active and new studies. Over 5.5 million research workflows are facilitated monthly on the platform, across activities like remote start-up, site management, monitoring, source data review and close-out.
SiteLink also integrates the site’s eISF directly with the sponsor’s eTMF for quality-controlled document exchange, whether the sponsor is using Florence’s eTMF solution or another vendor’s.
SiteLink enables research sponsors to integrate with three types of research sites: sites that already use Florence’s eBinders™ as their eISF, sites that use another vendor’s eISF, and sites without an eISF. For sites that use an eISF from another vendor, the open API will allow SiteLink to integrate with their existing systems. For sites that don’t have an eISF, the sponsor can partner with Florence to deploy eBinders, the #1 ranked platform by research sites on G2 for ease-of-use, support quality, and set-up.
SiteLink’s API and expanded integration capabilities will allow connected management of roles and permissions, inbound and outbound document exchange, and document status reporting for any regulatory and source documents involved in clinical research.
“SiteLink’s open integrations will help sponsors better equip their study sites for success and will allow them to work with frontier sites, those new to research, by deploying well-integrated, best-in-class technology,” says Gregor. “Linking sponsors to a network of traditional, major sites and frontier sites will allow any patient to participate in a clinical trial, accelerating timelines, increasing diversity, and advancing cures.”
Gregor goes on, “But to make this a reality, clinical trial technology vendors need to work with instead of against each other. Florence is embracing that philosophy by providing integrations and an open API.”
About Florence Healthcare
Florence Healthcare’s clinical trial software helps more than 10,000 research sites in 45 countries manage their documents, data, and workflows. The Florence Healthcare™ platform also provides remote access so sponsors and contract research organizations (CROs) can collaborate with their sites around the world. Florence Healthcare users now perform 5.5 million remote monitoring activities each month. To learn more, visit florencehc.com.