Florence Healthcare, a software startup in the Advanced Technology Development Center’s (ATDC) Signature portfolio of companies, said its eBinder offering for the clinical drug trial sector, grew more than 560 percent in March.
The company is focused on creating technology to cut costs related to the monitoring and validation of study site processes and documents in clinical drug trials. Site monitoring is a personnel-intensive process that requires visits, documentation, and other workflow requirements.
The Association for Clinical Research Professionals says the pharmaceutical industry spends roughly $35 billion a year on clinical drug trials to test new therapies and about $10 billion of that amount is spent on monitoring and validation of study site processes.
Florence Healthcare’s eBinder Suite simplifies these tasks for both trial sites and pharmaceutical sponsors. Site users of eBinders spend less time tracking, editing, and submitting documentation and more time advancing therapeutic research. Meanwhile, sponsors using the tool realize faster startup, more flexible electronic trial master file assembly (eTMF), and the ability to activate remote trial site monitoring.
“Our team focuses expressly on building tools that make study documentation easier and more compliant for sites,” said Ryan Jones, Florence Healthcare’s CEO. “It appears that the sharp growth in usage we’ve seen is the direct result of how easy it is for sites to transition to digital regulatory and source documentation work via our tools.”
Growth measured in March is based on the total count of study documents managed by the Florence Healthcare system across its customer base.
Separately, Florence Healthcare announced marquis research centers University of California San Francisco and Mount Sinai Hospital in New York joined its network of site customers. Research institutions use eBinders to accelerate startup and track compliance for studies spanning cardiology to oncology.
Florence Healthcare’s eBinders is built in alignment with eSource and GCP (Good Clinical Practice) guidance from the U.S. Food and Drug Administration (FDA) and the International Council on Harmonisation. The company also serves and the company serves on the Clinical Data Interchange Standards Consortium‘s eSource Stakeholders Committee with the FDA. Florence Healthcare was founded by experts in document management (Microsoft SharePoint), enterprise encryption security (Airwatch / VMWare), clinical trials (Medtronic), and healthcare (Emory). Software built by the Florence Healthcare team has been deployed to 6 of the 10 largest pharmaceutical companies in the world and to 600 academic medical centers.