Nancy Falls MBA Founder-CEO (Photo: Judith Hill)

THE CONCINNITY COMPANY LLC, based in Nashville, is raising capital to expand adoption of Cloud ConcinnityⓇ, the process-management platform it created and markets for use in programs undertaken by clinical trial sponsors and their allied clinical research organizations (CROs).

Concinnity is led by Founder-CEO Nancy Falls MBA. Chief Development and Legal Officer Heidi Solomon Allen JD joined as co-founder in 2016.

This market seems quite kinetic.

Looking to put the global clinical trials management system (CTMS) market quickly into perspective for fellow nonspecialists, VNC found this summary from SF-based Grand View Research.

At one point on its website, Concinnity asserts it offers "the most functional and comprehensive clinical trial oversight software on the market: a single, secure platform where all meetings, documents and processes can be centralized, automated and monitored, generating a complete audit trail."

In the course of interviews for this story, Falls confirmed for VNC that the company recently began a $500K convertible-debt bridge raise.

Proceeds from the bridge raise will extend Concinnity's runway while management considers revenue scenarios and tracks sector valuations, before pegging the company's first priced-round target, which is likely to fall somewhere in the $3MM-$10MM range, the CEO explained.

She told VNC that Concinnity management will soon be in "pretty constant conversations" with financial markets and strategics.

Heidi Solomon Allen JD

Concinnity has raised $4MM in outside capital since 2018, the year it launched its first software offering. Today, it operates with a virtual-first team of 12 FTE.

Falls, 67, told VNC that in pre-COVID 2019 Concinnity was approached by a potential suitor, but chose not to pursue a transaction, thinking it too early in the then-pivoting firm's journey.

Asked by VNC about eventual liquidity and exit options, Falls said that while organic growth now has priority, she does believes the company would "scale nicely" after taking aboard a strategic bidder or partner with complementary focus on adjacent software or services segments.

When asked her thoughts about eventually hiring someone to succeed her as CEO, Falls said "...while I love the day-to-day of working with my incredible team, I'm happy to play a new role when a strategic or financial investor comes to me saying they've 'got to have this company at any price'."

Falls added that she's known very successful entrepreneurs here and elsewhere who have remained successfully at their helms through many more pivots that she and Concinnity have experienced, thus far.

Concinnity's pivot to the CTMS market from its prior focus on providing software for traditional boards of directors and other committees has been underway several years.

Falls emphasized that CTMS has for some time been the company's singular strategic focus, although it still receives a modicum of revenue from earlier boardroom adopters.

"In the face of the pandemic," she said, "we pivoted to a use case in the life science vertical that had an even greater need for a solution to solve critical centralization, collaboration and compliance challenges than did corporate boards. Within a year of our pivot we were gaining the attention of the largest global players in this vertical and are now trusted with supporting dozens of clinical trials by top ten global CROs, pharmaceutical leaders and Key Opinion Leaders."

TEAM & ADVISORS

Matthew Cook

In addition to Co-founders Falls and Allen, the company's management includes CFO Michael Lalor, CPO Sarah McNew Razzaque JD, CTO Matthew Cook, Business Development Director Michael D'Amico, and Director-QA Nigel Walker.

Concinnity's business advisory board includes, in addition to Falls, Kyle Derham, Townes Duncan, Michele Flynn and Bo Sundstrom.

Its Clinical Trial Advisory Council members include sector veterans Susan Alpert MD PhD; Rob Grundy PhD; John Hedberg; Larry Meinert MD; Steven Sweeney; Dave Windley; and, Julie Krommenhoek.

Concinnity's outside advisors include attorneys with Dodson Parker & Behm, as well as with Bass Berry, and Hughey Business Law.

Concinnity banks with Pinnacle Bank -- via which Concinnity in 2020 accessed Treasury's PPP loan facility -- while its accounting assignments are with BDO and with Baker Sullivan & Hoover.

COMPS & CONSOLIDATORS

In December 2023, Concinnity was among a list of ten e-clinical trial management solutions companies considered notable by Pharma Tech Outlook.

The nine other companies in the PharmaTech listing included Switzerland-based Credent Partners' Medtack; Thermo Fischer's AES; Oracle partner Eclipse (plus Oracle's inhouse unit here); Boston-based AG Mednet (Judi); Oakland-based SimpleTrials; Richmond-based Slope; and, three North Carolina-based entrants, IQVIA Holdings, LabCorp and Studykik (Syneos). We note that other comparable listings include Captera's.

There's global innovation and M&A interest in CTMS. Brief VNC research surfaced numerous other CTMS sector entrants, particularly in North America and Europe, with, e.g., comparables in multiple regions including at least two in Zug, Switzerland, alone: WeMedoo.com and Oomnia.

We also spotted potential CTMS-related consolidators -- some of which are named above -- but others -- such as Blackstone-backed, Maryland-based Advarra -- are logically potential bidders.

For all previous VNC coverage of Concinnity, click here. VNC

.last edited 1745 9 August 2024