Atlanta-based clinical investigation trial site master file vendor Florence received an additional $7.1 million in Series B financing led by Fulcrum Equity Partners with participation from Atrium Health and Bee Partners. The vendor initially focused on-site master file digitization (much needed) and found it needed to also close the document exchange loop with sponsors and hence must use the capital to market and sell into big biopharma but competition is fierce with vendors such as Veeva that have a strong market position.

The quest to digitize document exchange between sponsor and site has not been as straightforward as many would have assumed. After all, document management, collaboration, and business process and workflow technology are ubiquitous and increasingly economical.

Florence

Founded in 2014 under the premise that they would supply software to replace paper-based investigational site files, trial master files and source binders they sought to develop and implement a shared platform for sites where remote monitoring would be simplified while improving quality and compliance for site-side eSource documents for instance. They tout that hundreds of customers trust their technology (eBinders) to transcend the paper-based study and its well-known roadblocks.

In fact, they report that they are now leveraging their progress of digitizing site trial document management as they begin to build a network of 5,000+ clinical trial sites and clinical trial sponsors for essential study documents and data exchange. It all centers on their “eBinders” platform and the infusion of fresh capital will allow them, they declare—to “digitally connect sites to pharmaceutical sponsors and clinical research organizations (CROs), creating a new type of research network that speeds progress” reported their CEO, Ryan Jones.

The Challenge

Florence is on a noble mission but they face a daunting reality. First and foremost the sponsor market for the electronic trial master file (eTMF) is now dominated by Veeva for software market share. With a $20+ billion market cap and what appears to be overwhelming market share for eTMF, Florence will have to “plug-in and play” tools with Veeva for sponsor side digitization. There is some big pharma still using Documentum-based trial master file-based technology and that will need to be considered as well. Florence will not have it easy selling sponsor side as they got their start 5 years ago selling into clinical investigational sites and didn’t build up the assets required to do business in “big pharma.” (although this could be changing with venture capital inflows). Sponsor side technology sales cycles are long (6 to 24 months) and expensive—not a friendly formula for startups—and $7 million can go fast.

On the site side, although Florence has seen some success selling its software based on press releases and market claims, there are many other vendors that offer digital site master file technology. In fact companies such as Forte Research sell not only regulatory document modules but also trial management, electronic data capture for investigator-initiated studies, etc.

Moreover Sites, often pinched for cash, frequently use tools such as Microsoft SharePoint for a baseline document management and collaboration (although this platform isn’t “validated” by itself and hence requires specialized customization).

Importantly, they must contend now with Veeva Site Vault Free which we reported on recently as “no site left behind.” 

As Veeva seeks to build a new form of connected document exchange network between Sponsor and Site—they also position a unified document and data offering to sponsors—something Florence seems to be trying to copy in some form. Veeva has an overwhelming advantage. And now that it is offering its Vault product (including assurance of regulatory compliance) free of charge to the investigational site the game of selling site trial master file software into sites just got seriously more complicated. Florence’s price point is considered high by some sites this author has lectured to—prominent NCI designated cancer centers for example. 

Florence’s Window of Opportunity

We have not reviewed Florence’s site-side software in great detail but we are aware they have signed up quite a few clients. For Florence to be successful at least four elements must be present. First software superiority—their site and sponsor-side software modules must be superior—not just similar to the quality and effectivity of a Veeva for example. Second, Florence must have superior domain expertise concerning site side dynamics—with rapid change in the clinical investigational site market there is a window of opportunity for the disruption that Florence can exploit if it understands what is unfolding. Third Florence must be able to hire the better talent (not only developers and architects but also professional services and marketing/sales) and fourth its vision for how to connect sponsor and site exchanges must transcend those of established players such as Veeva—the experience with their network must be overwhelmingly better for site usability and convenience.

Source: The State Journal

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