Founders, Fortitude, And Clinical Trials
By Dan Schell, Chief Editor, Clinical Leader
When I first started working for this company nearly 27 years ago, I was writing about resellers of technology solutions. These were mostly small businesses; many with less than 10 employees. I’d write about the challenges and struggles they went through, often just from running “a” business, not any type of business. You know, stuff like hiring, payroll, marketing, business development/management … the things that impact the success of a business often more than just having tech know-how or a “good/innovative” product/service (sorry for all the slashes).
Coincidentally, during the past month or so, I’ve had the opportunity to chat with a number of founders of new or very early clinical trials-related companies. Unlike those early assignments I had in this career, these interactions weren’t intentional, meaning I didn’t go into them thinking I was going to write an article about the companies. On the contrary, unless you’re a sponsor, site, or site network, I usually am not doing interviews with you, especially if you’re a vendor or service provider.
But man, I sure do enjoy hearing the stories of founders, and I do admire their tenacity and fortitude. And let me be clear; that goes double for site owners, who must deal with all the aforementioned challenges IN ADDITION TO all the tech challenges and crappy payment terms all while trying to serve patients who need them. I know, you’ve heard it before, but it bears mentioning it again here.
Now … what was I saying?
Building, Pitching, And Persevering
Oh yeah, I’ve met some founders both in person and via some calls lately that shared their business journeys, which I found super interesting. The first I’ll mention is Shruti Tiberwala, who I first connected with in February 2025 while her company, Double Blind Bio, was still in stealth mode. At the time, I think Shruti was the only employee of this company that designs “AI agents that automate clinical trial operations for research sites and sponsors.” We ran into each other at multiple subsequent conferences where she was always working hard networking and building relationships — both integral jobs for founders. When I reached out to her recently, she said the company has grown to 10 employees and has deployed across 200+ sites including 30 networks and some biopharmas. I don’t know anything about their product, but I know Shruti is the kind of founder a tech company needs; outgoing and can get into the nitty-gritty of the product design.
Another founder I admire is Wessam Sonbol of Delve Health. Like Shruti, it seems like I ran into him at every conference I went to for a while. I also remember, more than once, him pitching me hard to write an article about his company and product. Despite my rebuffs, I’ve always enjoyed our brief conversations. Last week at the ING conference, he shared the difficulties his company has gone through during the past six years, including one of the worst tasks a founder faces, reducing staff. But it seems, through his perseverance, that his company, which “combines eCOA, wearables, and human concierge support into one execution model that keeps studies running the way they were designed to” is now kicking butt. I talked with him about his new office in Egypt and he told me how he has been adding more and more staff. In one of his recent LinkedIn posts he also mentioned a company milestone: over 20,000 concierge conversations in a month. And of course, he’s at the SCRS Summit as I write this, and likely will be attending other fall conferences in the coming weeks.
Taking The Leap On A New Idea
At ING, I also caught up with Erika Talbott. I met her last year at … some conference … just after the company she was working for, Yonalink, got acquired by Veeva. When we spoke this year, I was surprised to hear she had decided to start her own company, JACKIE, which is part consultancy and part tech company that helps clinical companies maintain and improve their customer relationships. Keep in mind, our conversation about this brand-new company of hers took place in a loud and crowded restaurant/bar that was the host of the opening party at ING, so I may not have all the details correct. But what I did get is that through her experience working in customer and site success, Erika saw a need for a service that she felt so passionately about that she took that first scary step of going out on her own.
That’s a similar story of two other women I recently had calls with.
Megan Khaddar had worked in ClinOps for the past decade in pharma companies and CROs before venturing out on her own this past April to start bowlyn (yes, that “b” is supposed to be lowercased). Megan founded her company after repeatedly seeing ClinOps teams lose critical knowledge and rely on spreadsheets for trial oversight. bowlyn offers two solutions: Bridge, an on-demand service combining a company’s protocols and procedures with AI-generated, expert-reviewed operational guidance; and Compass, a configurable platform that replaces oversight spreadsheets with an auditable source of truth. Bridge is live, while Compass is being tested with early users. Megan said her biggest challenges are building the technology as a nontechnical founder, bootstrapping the company, finding early adopters, and communicating Compass’s value before it is broadly available. So, basically, what many founders struggle with.
I’m guessing Nermin Lafee could sympathize with Megan about starting a company on her own. She launched Cleanical late last year to expand clinical trial capacity and patient diversity in the Middle East by helping hospitals become research-ready and digitize paper-based processes. Most of her work has been done in Jordan, although she is trying to expand to Saudi Arabia. But there’s a problem, and it’s a big one. Despite offering tailored proposals, free assessments, training, staffing, and accreditation support, she has struggled to secure clients. When approached about taking on clinical trials, many of the hospitals there fear added workload, liability, and operational change, while Nermin — whose background is in clinical research, not sales — is still refining the company’s positioning and marketing. It’s been frustrating for her, especially since she has 10 years of experience in this industry and knows that her company could really help improve access to trials in these regions.
Looking Beyond Efficiency
Finally, I spent about an hour at ING talking with Rahlyn Gossen, who founded Revise 16 years ago after working at sites as a CRC. Her small, independently owned company — I believe it has fewer than 10 employees — offers a platform that helps sponsors communicate more effectively with sites (yes, I’m simplifying that). Our conversation ranged from her founder’s journey to Ken Getz’s Partnership for Sites keynote and the tension she saw between his argument that PE-backed site networks will bring needed standardization and efficiency and what sites were saying about the distinct operating realities that can make rigid standards counterproductive. That tension reflects a larger point Rahlyn often makes: The industry’s biggest bottleneck isn’t efficiency, but alignment, and no amount of AI will fix poor communication or make doing the wrong thing faster a good outcome. I also appreciate her willingness to admit that the longer she works in clinical research, the more she realizes how much she still has to learn — a mindset that may explain why she remains curious, independent, and still engaged after all these years. We even floated the idea of a webinar with Rahlyn and Ken to explore whether site fragmentation is really a bug to be eliminated or a feature that deserves more nuance. Nothing has come of it yet, but I hope it does.
My point in telling you about all these interactions isn’t to highlight these companies or their founders in any promotional way. No, It’s just me restating something you already know: Being a founder of any type of business in clinical trials — probably any industry — isn’t for the feint of heart. Some of these companies likely won’t exist in five years. In fact, a lot of people talk about how AI is not only spurring the proliferation of new “vendors” in this space but also hurting that growth by creating the vibe-coding revolution that’s enabling the would-be customers of those same vendors to create the “solutions” on their own. Indeed, “innovation” has its pros and cons.